As biosimilar development is expected to accelerate over the next decade, many customers are seeking packaging recommendations for these drug products. Because biosimilars are extremely sensitive to any changes from the innovator’s manufacturing and packaging processes, in every case it is important to understand the factors that affect the safety, purity and potency of the drug product as it relates to component selection.

Join our subject matter experts at the new West headquarters building for the 2013 Educational Series, “Supplying Safe Medicines to Patients: Considerations for Container Closure and Delivery Systems.”

With the explosive growth in social media, mobile devices, cloud computing and access to data both internal and external to West (now referred to as Big Data), West IT has been working to ensure that we are able to leverage these transformational trends. In 2012, we updated our IT strategy to allow us to be part of the revolution while making it feel more like an evolution. The initial phase began with investments in cloud technologies – both private and public – to drive down IT operating costs and to enable us to take advantage of software enhancements made by our strategic partners.

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Patrick Curran¹, Vinod Vilivalam¹, Suzanne Kuiper² and Derek Duncan^2
1West Pharmaceutical Services, Inc. and ²Lighthouse Instruments B.V.

An increasing number of pharmaceuticals including vaccines, stem cells and proteins require cold storage to maintain efficacy prior to use. However, the ability to maintain container closure integrity (CCI) during cold storage is not completely understood. Concerns about CCI failure have been raised for the storage and shipment of pharmaceutical products in rubber-stoppered vials under cold conditions (e.g. -80°C or dry ice). Commonly used butyl stoppers are believed to lose their elastic properties below their glass transition temperature (Tg) posing a risk to sealability [1], [2]. The temporary loss of CCI under cold conditions can allow cold, dense gas from the surrounding low-temperature storage environment to leak into the stored vial. The ingress of the gas can contribute to loss of efficacy of the stored drug product due to interaction with the gas as well as overpressurization of the vial. Overpressurization occurs when cold, dense gas becomes trapped within the vial as the rubber stopper warms to a temperature above its Tg after it is removed from the cold storage conditions. After the rubber stopper has regained its elastic properties and reseals the vial, the headspace pressure of the vial increases as the cold, dense gas warms to room temperature.

West’s Fran DeGrazio, Vice President, Global Research and Development, will present, “QbD for Elastomeric Components – A Case Study” with Mihaela Simianu, Research Advisor, Manufacturing Science, Eli Lilly and Company, on Tuesday, May 14 at 10:30 a.m. at the 2013 PDA/FDA Container Closure Components and Systems Workshop.

• Tom Forte, Senior Research Scientist, Battelle
• Ronald Forster, Director, Packaging Design/Engineer, Amgen, Inc.
• Dana Guazzo, PhD, President, Research & Development, RxPax, LLC
• Desmond Hunt, PhD, Senior Scientific Liaison, Standards Development, USP
• Donald Klein, PhD, Senior Reviewer Chemist, ONDQA, CDER, FDA
• Frederick Stearns, Partner, Keller Heckman Law Firm
• Kalavati Suvarna, PhD, Microbiologist, DMPQ, Office of Compliance, CDER, FDA

Prior to the workshop, PDA's Training and Research Institute (PDA TRI) will hold the Essential Elements of Extractables & Leachables: From Material Selection to Final Report course. This course will demonstrate through examples and case studies the essential elements of the extractables and leachables process from the selection and evaluation of packaging materials to the writing of the study report – conversion of data to information.

West is pleased to kick off the West without Borders fundraising initiative for 2013! In 2012, our global team raised more than $260,000 for local charities that aid children in need. This year, we have once again chosen to aid children by supporting charities located close to our facilities.

Since its inception in 2004, when our fundraising programs aided those affected by the Asian tsunami, West team members around the globe have helped the West without Borders campaigns raise more than $1.25 million to support a variety of charities. Recent campaigns have focused on local charities, and our success over the past several years has only grown. In 2012, we raised more than $260,000, outdoing our 2011 campaign by more than $50,000. In 2010, our first campaign targeting local charities, team members raised more than $200,000, and we’re looking forward to another stellar fundraising year.

The drive for high-quality packaging has helped manufacturers focus on increasing consistency of performance in devices such as auto-injector and patch injection systems. In addition, there is an increased focus on providing drug delivery systems that are easy to use. A consistent quality of components can help to improve performance and ensure delivery in the home environment, while user-centric systems can help assist with compliance.

On December 1, 2013, the United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010) revised standard will become effective. The revised chapter affects all injectable drug products, human and veterinary, intended for sale in the United States.

West Pharmaceutical Services, Inc.’s Carol Mooney, Global Market Segment Director, Pharma/Biotech, offers guidance to pharmaceutical manufacturers seeking to comply with the new standards.

In addition, the revised chapter restricts printing to cautionary statements, which are statements intended to prevent an imminent life-threatening situation and may include instructional statements that provide potency or other safety-related instructions if warranted. Cautionary labeling statements must be simple, concise and devoid of non-essential information. Only cautionary statements may appear on the top (circle) surface of the ferrule and/or cap overseal of a vial containing an injectable product. The statement should be printed in a contrasting color and be clearly visible under ordinary conditions of use. Other statements or features, including but not limited to, identifying numbers or letters, such as code numbers, lot numbers, company names, logos or product names, may appear on the side (skirt) surface of the ferrule but not on the top (circle) surface of the ferrule or cap overseal.

Visit West’s online resource center for more information and watch for additional Frequently Asked Questions on USP Ch <1> coming soon!

Camp Victory, which is located in Millville, Pennsylvania, operates camps for children with special needs and children who live with chronic health disadvantages including spina bifida, autism and cancer.  In 2007, West donated the funding and manpower needed to build a wheel-chair accessible tree house and has maintained an affiliation with the camp ever since.  So when Camp Victory sent out a call for fundraising as part of its 2013 Corporate Sponsorship Program, West was pleased to become a Corporate Partner with a donation of $25,000.

West presented a check to Camp Victory on March 28th 2013.  From left to right: Rick Luzzi, VP Human Resources; Don Morel, Chairman and CEO; Dave Bergerstock, Sr. Director, Operations; Jim Collins, Plant Manager, Jersey Shore, PA; Dave Lanzer, Plant Manager, Williamsport, PA; Jamie Huntley, Executive Director, Camp Victory, Jim Smith, Board member, Camp Victory;  Joanne Troutman, Marketing Director, Camp Victory.

“West has had many years of friendship with Camp victory, and the Pennsylvania plants have continued to support the camp through donations of time and money,” said Dave Bergerstock, Senior Director of Operations, Americas.  Dave also serves on Camp Victory’s Board of Directors.  “We’re very pleased to become a Corporate Partner as part of the 2013 Partnership Fundraising campaign, and look forward to continuing to support Camp Victory as much and as often as we can.”

On April 14, 2013, West celebrated its 90th anniversary. This landmark occasion commemorates our long history of working side-by-side with top pharmaceutical and biotechnology companies around the globe to meet the biggest challenges  in delivering life-changing therapies safely and effectively to patients.

Every day, more than 90 million West components are used around the world, from vaccines to at-home drug administration, to injections in hospitals and other healthcare settings. Since West’s founding in 1923 by Herman O. West, collaboration, innovation and partnership have been in the company’s DNA.  Leveraging 90 years of experience, West works collaboratively with the pharmaceutical and biotechnology industries to understand their needs, navigate the global regulatory landscape, and help design and manufacture packaging and drug delivery systems to bring safe, effective drugs from concept to the patient.

“As we commemorate our company’s 90^th year of serving healthcare markets, we look back with pride on the role West has played helping deliver drugs safely to patients around the world,” said Donald E. Morel, Jr., Ph.D., Chairman and CEO. “From packaging systems that enabled the wide-spread distribution of drugs such as insulin and penicillin to innovations that enable the administration of today’s biologic drugs, West has been and will continue to be by the side of our pharmaceutical customers and patients for a healthier world.”

In addition to the company’s dedication to helping deliver life-saving therapies, West has made philanthropy a key priority. Each year, West employees around the world donate their time and money to assisting children and families in need.  In 2012 alone, contributions to various organizations around the world exceeded $600,000 for organizations dedicated to caring for children in the many communities where West employees live and work. 

Learn more about us!​

At West, we have adopted the philosophy that there are no IT projects, only business projects.  Even business projects with a high dependence on IT are still business projects that require a business case with a measurable return on the investment.  During the past year, West has been working to develop a unified project and portfolio management process.  The initiative’s main goal is to ensure that we derive the full value from all business investments, including those that require IT enablement. 

West is pleased to announce that it has become a multi-year foundation sponsor of the Young Men In Charge Foundation, Inc. (YMIC). The program is dedicated to increasing the number of African American and Latino males in science, technology, engineering and math (STEM). West’s sponsorship will support the Foundation’s mission of integrating STEM exposure and mentoring with a focus on leadership, business and social skills.

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Sascha Karhöfer, Director Global ICS Platform at West, presented “New Elastomeric Formulation and Relevance of Quality by Design (QbD) in Primary Packaging” on March 19, 2013, at Pharma-Kongress: Production and Technique in Dusseldorf, Germany.

Join West’s Diane Paskiet at the 2013 PDA/FDA Container Closure Components and Systems Workshop:Protecting Parenteral Drugs and Biologics Using Suitable Container Closure Systems, on May 14-15, 2013, at the Hyatt Regency Bethesda in Bethesda, Maryland.

This 1 1/2 day workshop will tie together a broad scope of attributes for container closure systems and the potential impact to the quality of therapies from the point of component selection, to the manufacture of the medicine and delivery to the patient. The discussion will touch upon packaging materials, components, delivery systems, human factors, supply chain and Quality by Design. 

West has created a technical resource site to provide its customers with specific product information that is available whenever our customers want it – 24 hours a day, 7 days a week!

West Customer Connection is an online, secure resource that serves as a central location for a variety of West’s technical information, including West’s prefillable syringe technical reports and bulletins. Documentation supporting NovaPure® and ReadyPack® components will be available soon.

                        1 Bennett St.
                        Cambridge, MA 02138

In addition to enabling some of the traditional processes that IT is called upon to support, West IT has been given the opportunity to support West’s global knowledge management initiative. Our colleagues in Quality Assurance and Research and Development have enlisted IT to assist in the enablement of our Knowledge Management strategy. We are currently in the discovery stage of the initiative: identifying all the source systems (both internal and external) and databases where information is stored across the enterprise, and determining who will need access to that information and in which languages.

Author:


Beverly Prohaska
V.P. Global Information Technology
Beverly.Prohaska@westpharma.com

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While you won’t see cats on vacuums, cute dogs doing crazy tricks or any dancing toddlers, the WestFYI YouTube Channel does offer a variety of product videos to help customers and potential customers learn more about West’s products and our company.

The PDA Annual Meeting, “Modern Sterile Product Manufacture – Exploring Best Practices and Seeking New Approaches,” will be held April 15-17, 2013, at the Peabody Orlando in Orlando, Florida.  This meeting will focus on the challenges currently faced by the pharmaceutical industry, advances in modern manufacturing and look ahead to the future of the industry.

At West, we’re always interested in learning more about the pharmaceutical industry and how we can support and partner with our customers to provide innovative solutions to their drug product packaging and delivery needs.  We’re by the sides of our customers from concept through commercialization with industry expertise and manufacturing excellence.

A European Customer Satisfaction Study conducted in 2012 offered West customers a chance to be heard, and provided a contribution to the José Carreras Leukämie-Stiftung (José Carreras Leukemia Foundation) based in Munich, Germany. The EU-wide study was conducted as an online survey and ran throughout the summer. To encourage customer participation, West made a charitable contribution for each completed survey. Thanks to a high level of customer participation (customers from 28 countries provided feedback), West was able to generate €2,260 (more than $3,000) for the charity. The donation will support:

West is pleased to announce the commercial introduction of its ID Adapter, an accessory designed to help improve consistency and reliability of intradermal injections for vaccines and other injectable drugs.

The ID adapter, which recently received 510K clearance from the U.S. Food and Drug Administration, complements West’s portfolio of prefilled syringe offerings and technologies.  Designed for use with  1 mL allergy syringes, the ID adapter consists of a sterile, disposable, single-use injection molded part that:

Click here for more information or call your West account manager or a Technical Customer Support representative.

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On December 1, 2013, the United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010) revised standard regarding labeling for cap overseals and ferrules on injection vials will go into effect. This revised standard may affect seals customers currently purchase from West.

West’s subject matter experts are out and about this spring with speaking engagments and booths booked at a variety of conferences and trade shows.  Come out and see us at one of the following events:

West has announced a new online resource center to assist pharmaceutical and biopharmaceutical manufacturers as they prepare for the industry’s revised standard regarding labeling for cap overseals and ferrules on injection vials, United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010).

The revised USP General Chapter <1> Injections standard will go into effect on December 1, 2013. The standard applies to multiple packaging, storage and labeling requirements, as well as procedures and methods that provide specifications for individual drug products or substances. The revision will limit printing to cautionary statements on the top surface of the ferrule or cap overseal of a vial containing an injectable drug product. A cautionary statement is defined as one intended to prevent an imminent life-threatening situation if the injectable drug is used inappropriately.   

The West USP General Chapter <1> Online Resource Center is designed to provide drug manufacturers with key information, considerations and regulatory assistance to prepare for implementation of the revised standard.

“The revised standard represents a fundamental shift in the pharmaceutical and biopharmaceutical industry, and drug manufacturers need to begin preparing now for implementation,” said Carol Mooney, Global Market Segment Director. “West is working side-by-side with customers to provide high-quality insight and guidance through the transition and ensure uninterrupted product supply.”

The West Online Resource Center is available here. 

For more information about the USP General Chapter <1> revised standard, visit http://www.usp.org/usp-nf/notices/retired-compendial-notices/general-chapter-injections-labeling-ferrules-and-cap-overseals-section. 

Lyophilization removes water from a drug product through three phases: freezing, primary drying or sublimation, and secondary drying or desorption. To begin the process, the drug product is frozen and then placed under a vacuum, which allows the ice to change from solid to vapor without passing through a liquid phase. The process typically includes the following phases:

According to the FDA, lyophilization has many advantages, including enhanced stability, extended shelf-life while maintaining potency, increased resistance to changes in temperature, and rapid and easy dissolution of the reconstituted drug product. However, the process requires increased handling and processing time, and can be complex and costly – particularly if the materials selected for the primary container are not consistent or interfere with the lyophilization process. The proper selection of a lyophilization stopper manufactured with Quality by Design (QbD) principles can help to ensure that the freeze-drying process moves smoothly while preventing and/or reducing potential contamination from the atmosphere or the container closure system.

Visit http://www.westpharma.com/en/products/Pages/SmallVolumeStoppers.aspx to learn more.

Author:

Sascha Karhoefer
Director, Global ICS Platform
Sascha.Karhoefer@westpharma.com 

Beyond the challenges of ensuring that data privacy laws are observed across the globe, West IT is faced with the need to safeguard intellectual property, trade secrets, and confidential company and employee data while ensuring that we can serve our global customers. This is becoming increasingly more complex with the rapid advances in mobility and cloud computing. At West, IT is evaluating the best way to enable our employees to take advantage of these rapid advances in technology while still ensuring protection for confidential company information.

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Employees at West’s Eschweiler, Germany, facility celebrated the holidays with a party that had some very generous results.  The party took place on December 15, 2012, with more than 520 employees attending and participating in a lottery for three superb prizes, including a flat-screen television, digital camera and gift voucher for gas.

From left to right: Elli Dahmen, Eschweiler; Heiko Schutz, Production Manager Eschweiler; Andreas Thiersch, QA Manager, Stolberg; Brigitte Vlaovic, Fortschritt; Marita Holper, Fortschritt; Helga Bayer-Steguweit, Eschweiler; Simon Rühe, Manager Finance & Controlling Germany

A scientific poster by: Clara Goodfield, Eugene Polini, Amy Miller and Wayne Curry

OBJECTIVES

Employees of The Tech Group Puerto Rico donated $1,000 to Optometry Giving Sight (OGS), an organization dedicated to helping people around the world who are blind or vision impaired. OGS is a global fundraising initiative that specifically targets the prevention of blindness and impaired vision due to uncorrected refractive effort – simply the need for an eye examination and glasses. Created in 2003 by the World Council of Optometry, the International Centre for Eyecare Education and the International Agency for the Prevention of Blindness, OGS helps to mobilize resources from the global optometric community to fund the development of sustainable eye care products in communities where need exists.

L-R: Grace Seilhammer, Cooper Maintenance, Repair and Operations Buyer;  Glenda Robles, Cooper Purchasing Manager; Ruben Aguayo, Tech Group Puerto Rico Plant Manager; and Vanessa Alvarado, CooperVision Human Resources Senior Manager.​

Bart Burgess, Director, Business Development, Self-Injection Systems at West, and Peter Krulevitch, Ph.D., Engineering Director, Packaging, Devices & Delivery at Janssen Pharmaceutical Companies of Johnson & Johnson will present “A New Self-Injection Technology and Unique Partnership” at the Drug Delivery Partnership Conference.  The conference will be held February 6-8, 2013, at the Hilton San Diego Bayfront, San Diego, CA.

In a recent post, my colleague Diane Paskiet discussed testing for extractables and leachables. Often, leachables migrate from a container closure system into the drug product. To help mitigate risk from leachables, West offers a variety of solutions, including closures coated with FluroTec barrier film.

FluroTec stoppers have been used widely in the pharmaceutical industry for close to 10 years. FluroTec, a fluoropolymer film (ETFE), is applied during the molding process to the elastomeric material. The film easily bends to cover the unique surface shapes of closures and pistons used for lyophilization and dry powder applications. The film is typically applied to the drug contact surface of a closure, but can also be placed on the top, non-drug contact side, to help prevent lyophilization chamber shelves from sticking to the vials during the lyophilization process.

A FluroTec laminated stopper works well to eliminate the need for free silicone oil as the FluroTec film has lubricious characteristics. This lubricity aids in machinability and stopper seating during filling. The film also works as a barrier to drug product interaction with the closure material, reducing extractables and leachables of the packaging components.

For more information on West’s FluroTec packaging offerings, contact a TCS rep to discuss a FluroTec closure selection.

Joanne Neizer
Joanne.Neizer@westpharma.com

FluroTec® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
FluroTec® technology is licensed from Daikyo Seiko, Ltd.
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In 2012, West rolled out a new global branding initiative that included a new tagline: By Your Side for a Healthier World^TM. What does that mean? Every day, injectable drugs and vaccines are administered to improve the health of millions of patients around the world. And every day, West works by the side of its health care partners to design and manufacture drug packaging and delivery systems that will bring those drugs and vaccines from concept to the patient more efficiently, reliably and safely. This has been West’s legacy since the Company was founded in 1923.

Customers know West for its high-quality products and as a global partner that can meet their needs in a challenging and changing industry. The new tagline emphasizes that West works in partnership with its customers as they move their product from concept to the patient. By doing so, West offers expertise and insights that can help develop comprehensive solutions for our customers’ drug development, manufacturing and delivery needs.

Watch our new video here: http://www.westpharma.com/en/about/Pages/OurValues.aspx  

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The West sales office located in Buenos Aires, Argentina, chose to support Obra Dominical Recreativa para Especiales, or O.D.R.E., (translated: Recreational Dominical Work for Special People) for the 2012 West without Borders fundraising initiative.  The civil association, which was suggested by employee Christian Jimenez, provides support and services to those suffering from mental illness.  Employees purchased a variety of items to support the association’s efforts, including musical equipment, food, plastic chairs and products for handicrafts. 

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Reza Esfandiary¹, Sangeeta B. Joshi¹, Vinod Vilivalam² and C. Russell Middaugh¹

Over the past several decades, IT has moved from a data-center model, where most information and data was inside the enterprise, to the Internet, where there’s more information outside the four walls of the enterprise than within it.  More recently, the pervasiveness of mobility, social media, and bring your own device (BYOD) and cloud (BYOC) are bringing about both technical and cultural changes that are profoundly changing enterprise IT and computing. 

Much like the Internet in the 1990s, the greatest impact to enterprise IT is coming from the personal adoption of mobility that is assimilating into the workplace.  The onslaught of BYOD in combination with cloud services is shaping corporate change.  In its narrowest definition, BYOC is where employees save their personal and work-related data and files in the cloud.  It is said that the ancient Vikings were successful because they were the first to see water as a highway and not merely as a defensive barrier.  With a comparable mindset, IT must invert the way we view BYOD and BYOC.

Author:

West’s Glen Zimmermann, Director, Sales & Marketing, Administration Systems, and Alvaro Estrada, Senior Director, Strategic Program Management and Technical Operations, will present, “Considerations for Integrated Drug Delivery Systems: Exploring new technology and innovation in injectable drug therapy devices” at the ISPE-DVC January Program Meeting on January 15, 2013, from 5:00 p.m. to 8:30 p.m.

For the 2012 West without Borders campaign, the headquarters team selected to support Caron Treatment Centers, a nationally recognized non-profit provider of alcohol and drug addiction treatment. With experience in treating co-occurring disorders, Caron offers comprehensive treatment programs for adolescents, young adult, adults and their families.  Its mission is to provide an enlightened, caring treatment community in which all those affected by alcoholism or drug addiction may begin a new life. Caron is based in Wernersville, Pa.

The 2012 West without Borders fundraising campaign raised nearly $250,000 for organizations dedicated to caring for children in the many communities where West employees live and work.  Since its inception in 2004, West without Borders has raised more than $1,000,000 to help those in need around the world.

West executives and West without Borders committee members present representatives from Caron with the 2012 donation from Lionville employees.  From right to left: Rick Luzzi, Christina Zion, Joel Miranto, Susan Gilman, Don Morel, Sue Hendrickson (Caron), Janet Cooper, Kurt Hershey and Dave Rotenberg  (Caron). 

Last month, I gave an overview of how West’s IT strategy supports the “One West – Customer First” business strategy through three major investment areas:

Teams Place 15 and 28 out of 120 Teams

DragonPhlame rowed to third in the qualifying race, fourth in the semi-final and 5^th place in the C Division finals with a time of 2:36.97.

In a ceremony on September 27, 2012, West’s German facilities, Kiefernweg, Eschweiler and Stolberg, presented “Förderkreis Schwerkranker Kinder” and “Förderverein Fortschritt” with more than €12,000.  The funds were raised as part of the 2012 West without Borders charity campaign.

For the past three years, the three facilities have teamed up to collect money for  charity organizations.  This year’s selections support handicapped children and those that suffer from severe disease as well as their families, who may have difficulty covering the cost of treatment.

For many years the pharmaceutical industry has siliconized elastomeric closures to reduce the coefficient of friction so that machinability, insertion forces and closure functionality are improved. West siliconizes elastomers through the addition of a pharmaceutical grade silicone oil fluid emulsion in the Westar^® washing process or by the application of B2-coating, a technology licensed from Daikyo Seiko, Ltd.

 

Patrick Gallagher
Patrick.Gallagher@westpharma.com

Employees at West’s Kinston, North Carolina, facility understand how important it is to give back to others in the community who need a helping hand.

Says Ken Morris, Plant Manager, “I am truly amazed by the generosity of our employees and the West organization. It is an example of living the Company’s values in a way that really benefits the citizens and community where we live and work.”

In 2012, the employees at the Kinston facility set new internal plant records for both the United Way and West Without Borders fundraising campaigns. Employees raised a total of $68,522 for both campaigns, with $45,452 going to United Way and $23,070 donated to charities as part of the West without Borders fund drive. With the match from the H.O. West Foundation, the Kinston employees were able to offer more than $118,000 to help the community.  Since 2004, the facility has raised more than $700,000 for its community.  

The United Way agency for Lenoir and Greene Counties provides support for member agencies located in and serving these communities. Many local businesses actively support this worthwhile effort and many provide incentives to encourage donations. One such effort is the donation of a new car to be awarded to a “fair share giver” in the community. This year’s United Way campaign theme was Race to Donate; a tie to North Carolina’s NASCAR heritage.

For the West without Borders campaign, the Kinston employees selected the Ronald McDonald House of Eastern North Carolina and the Children’s Home Society of North Carolina as the charities that they wished to support. The theme for this campaign was Summer Love. With a service area covering much of Eastern North Carolina, these charities provide a wide range of support to local families of children in need. Because there are so many deserving charities to choose from, selecting just two was not an easy process.

“A committee made up of a cross-section of our site’s employees goes through an extensive process to identify and determine which charities in the community are most in need of our support at that point in time,” said Morris. “The group takes this responsibility very seriously and asks management to support its recommendations. Our employees want to know what their support will be used for and where it will do the most good. It is an extensive process and one that our employees very actively support.”

The funds will go far to serve many individuals and families in need throughout the Kinston area, and the Kinston employees are all smiling, knowing that they have made a strong difference in the lives of those in need.

 

From left to right (foreground): West employees Sandra Jarman, Mary Margret Gore and Jay Conner; (background) Susan Bland and Glenda Washington.

From left to right: West employees Jay Conner, Rosa Whitfield, Ronald McDonald House Marketing Director Erin Acree, West employees Susan Bland and Sandra Jarman; (background) Ronald McDonald House President of the Board of Directors Donald Pack, West employees Jim Merkel, Rocknard Williams and Daryl Freeman.

 

 

 

 

 

 

As a parenteral packaging provider for a number pharmaceutical companies specializing in generic products, West is often asked whether or not a generic drug should use the same packaging components as the innovator.  The answer depends on the innovator’s packaging choices as well as the desired chemical and functional properties for the container closure system.

Think back on your favorite childhood memory. Did it involve camping?  Climbing a tree? Running through open fields and playing with friends?  For children who attend Camp Victory, in Millville, Pennsylvania, such childhood rites of passage can be more than hard to come by. 

“At the end of the day, everyone knew the ultimate goal was to benefit the Upward Foundation,” said Mike Treadaway, Vice President and General Manager, Tech Group America.  “We’re pleased to be able to provide support to those who help so many special children and adults.”

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The responsibility to protect a temperature sensitive drug product should be shared by all supply chain stakeholders to ensure patient safety. Any deviation from the defined temperature range that occurs during manufacturing, distribution and storage might impact patient health and recovery. Temperature-controlled supply chain integrity not only refers to cold-chain-maintained drug product distribution, but also to medicine that should be kept at ambient temperatures. The aim is clearly to maintain product quality, safety and efficacy, which can be achieved by minimizing risks such as product degradation, product adulteration, counterfeiting and theft.

Temperature-controlled supply chain integrity and security were among the topics discussed at the PDA conference on Cold Chain Management in Berlin in October 2012. Challenges include the complexity of global distribution, environmental conditions, geopolitical boundaries, local lack of a reliable infrastructure and different regulations worldwide. Temperature monitoring is mandatory and supported by various technologies such as USB data loggers, RFID and even real-time monitoring via GPRS tools. Data analysis, storage and protection, as well as the organizational challenges in cross-supply-chain coordination are critical since all sub-contractors need to use the same technologies.

Awareness, visibility and transparency are important targets for improvement. This is especially difficult for the last step of the so called “Last Mile”: the delivery of the drug product from pharmacies to patients. A new Good Distribution Practices guideline for Europe is currently under review and will be implemented in 2013. Also, the USP is developing a new version of the regulation regarding pharmaceutical supply chain integrity. The new regulation will include education of inspectors and investment in new technologies or upgrading existing equipment by companies involved in the supply chain of temperature-controlled drug products. Economically these expenditures may find some compensation in the reduction of wasted drug products for which the temperature profile is unknown if returned to the pharmaceutical industry or wholesaler. A complete temperature log file could save money, but what is far more important is that the security and integrity of a temperature-controlled supply chain will save patients’ lives.

Lisa Bavis, Laura Stubbs, Diane Paskiet

Are you in a quandary?  Are questions like the following going through your mind?

Joanne Neizer

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At West, our IT strategy is founded on the principle that all IT investments should enable us to leverage our global presence and better serve and manage our customers.  To this end, we have agreed that the core IT investments that will enable us to achieve our goals are made up of the following three pillars:
 
• Customer Relationship Management, or CRM
• Supply Chain Management, or SCM
• Business Analytics to measure how we’re meeting our goals

We launched our CRM initiative, Project Chronicle, in April 2012 to more than 300 sales, marketing and other customer-contact professionals across 14 countries.  In the first six months since the program was launched, feedback has been positive as we become comfortable with new business processes and visibility to customer information.  As Chronicle becomes part of our day-to-day operations, we are initiating the next of the three pillars – supply chain management – to enable West to leverage its global presence.  Next month, I will provide a more detailed glimpse into the goals of the SCM program and how IT fits in. 

Author:

 

Bev Prohaska
Beverly.Prohaska@westpharma.com

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There is a rising need for auto-injection systems that can treat a variety of conditions, including autoimmune, diabetes, anti-migraine, rheumatoid arthritis and multiple sclerosis, hepatitis C and other areas such as reproductive health.

Tibor Hlobik
Tibor.Hlobik@westpharma.com

In September 2012, the employees of West’s Kearney, Neb. facility celebrated the plant’s 50^th anniversary with a host of events for employees, retirees and families.  More than 300 employees attended a formal dinner, where executives including CEO Don Morel, Jeff Hunt, Bill Federici, Rick Luzzi, Karen Flynn, Jim Faust and Troy Player were on hand to help celebrate.

Since 2010, West’s Colombia employees have been on mission to make life more normal for one special young lady.  Eight-year-old Karen was born with a femur problem that requires the use of a prosthesis.  To remain active and comfortable as she grows, Karen needs a new prosthesis every 12 to 18 months.

Since receiving her first prosthesis thanks to donations from West Colombia in May 2010, Karen has been able to lead a normal life. She attends school and plays with friends. As Karen grows, her prosthesis becomes uncomfortable, which lowers her activity level.

To learn more about Karen, check out the West without Borders special issue.

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Growth in injectable therapies has resulted in an increasing number of new biologic drug products. Treatment regimens for these products can be complex, and often fall directly to the patient or a caregiver rather than a trained clinician. Many new and desirable treatments may require larger doses, which would require multiple injections by the patient. Biologic drug products are often of a higher viscosity and may require a high-volume dose that cannot be easily delivered using traditional methods. Delivery devices such as pens, auto-injectors and patch injectors are often the best choice for self-administration. 

Graham Reynolds

Don’t miss the last installment of West’s 2012 Educational Series!  Join our subject matter experts on November 9, 2012, in San Francisco, California, as we present “Pharmaceutical Development Considerations: Injectable Delivery Systems Quality Planning.”

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Providing the best solution to the challenges of packaging and delivering today's sensitive and complex biopharmaceutical products requires not only an effective drug container, but also a delivery system that can enable safe, effective and reliable delivery of the medication, especially when the administrator may be a patient.

West will be responsible for co-developing and handling the commercial scale-up and manufacture of the product, and will have the ability to offer the SelfDose injection technology as part of its expanding portfolio of self-injection technology platforms. The SelfDose injection technology complements West's ConfiDose® and SmartDose® injection technologies, and offers a solution for improved manual injection.

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While it is easy to minimize the importance of social media, it is clear that protecting West’s reputation and shaping the buzz about West in social media is growing in importance.  West is actively participating in Twitter, LinkedIn and Facebook, and is well-positioned to tap the power of social media to manage business risk and drive growth. 

Beverly Prohaska
Beverly.Prohaska@westpharma.com

In today’s healthcare industry the expectations are for zero defects. West, as a provider of pharmaceutical packaging components, is constantly challenged to meet extremely high quality standards. Pharmaceutical manufacturing requires physical inspection of filled containers to reject those showing evidence of contamination with visible foreign material. Biopharmaceutical drug products in particular are scrutinized for particles.

Packaging components are an important subset of this process. Component manufacturers can contribute to reducing particulate matter in finished drug products by supplying closures with reduced embedded and adhered particles. Vision inspecting components leads to improved upstream quality in the closure manufacturing process; verification of this improvement provides a lower risk of rejecting the final drug product for particulate and foreign material.

Driving quality and product understanding upstream to the component manufacturer may improve the finished goods production process. Helping to reduce customers’ end-of-line rejects is a major benefit of 100% vision inspection of rubber components.

 

Peggy Frandolig
Director, Technical Customer Service
Peggy.Frandolig@westpharma.com

West’s 2012 Educational Series is coming to a close – don’t miss your chance to attend!  Join us on November 9, 2012, in San Francisco, California, as our subject matter experts present “Pharmaceutical Development Considerations: Injectable Delivery Systems Quality Planning.”

The PDA Universe of Prefilled Syringes and Injection Devices conference is just a few weeks away, and West will be attending and speaking at the event.  This year’s theme is “Integrating the Unmet Market Needs: Bringing it All Together for Tomorrow's Success” and the conference will be held October 15-17, 2012 at the Red Rock Resort and Spa in Las Vegas, Nevada.

• Quality Infrastructure and Issues
• New Technologies and Trends in Manufacturing Processes
• Case studies
• Human Factors/Usability
• Injection Devices: Critical Attributes and Risk Management
• Regulatory and Compliance Aspects Such as Combination Products
• New primary Containers, Safety Devices, and Delivery Systems
• Global Market Trends

Erik J. Woods_1,2, Aniruddha Bagchi₁, Robert Nase₃ and Vinod Vilivalam₃
1General BioTechnology, LLC, Indianapolis, IN, USA; 2Department of Microbiology and Immunology,Indiana University School of Medicine, Indianapolis, IN, USA; and 3West Pharmaceutical Services, Inc., Lionville, PA, USA

With the upcoming move to our new global headquarters building in December, West employees will soon have faster and more reliable access to collaboration technologies than ever before. West’s information technology team has been actively involved in the design and move to the new building since the initiative started in 2010. The building features two new conference centers fitted with Cisco telepresence technology for collaborating with other West facilities. West will also have the capability to hold telepresence sessions with customers and suppliers who use the Cisco telepresence technology.

Bev Prohaska
Beverly.Prohaska@westpharma.com

For the 2012 West without Borders campaign, West Brazil once again teamed up with Lar São José.  West Brazil has supported Lar São José since 2004 by supplying them with food and other needed products.

During the month of May, West employees participated in candy sales, equipment auctions, raffles, a charitable breakfast and bingo to raise money for the organization. Employees also donated food, items for the home and money to the campaign.

To learn more information about Lar São José, please visit http://larsaojose.net (Portuguese site).

Glass constituents as well as conditions for shaping container systems can have an impact on overall glass quality and suitability for use with today’s pharmaceutical and biopharmaceutical products. Glass is not chemically inert. Variability is inherent to the source of raw materials used in glass and can give rise to differences in a container’s chemical make-up and quality. Silica (SiO₂) from naturally occurring sand or rock may originate from various regions. To process glass, fluxes such as sodium or potassium can be added to lower melt temperature. Also, stabilizers may be used to improve durability and reduce potential for glass to break down into its constituent parts. Finally_, there are a variety of naturally occurring minor trace elements in glass that can have an effect on the forming process and an immeasurable impact on the quality of drug products. Variation in the glass batch constituents and forming conditions can affect the quality, durability, workability characteristics and aesthetic appearance with an overall impact on short-term and/or long-term drug product quality.¹

Director
Diane.Paskiet@westpharma.com

Tech Group Europe partnered with Temple Street Children’s Hospital for the 2012 West without Borders campaign.

On Friday, May 25, the staff at Tech Group Europe gathered for a stationary cycling event to raise much needed funds for the Hospital. The group cycled the equivalent distance from Malin Head to Mizen Head (500 km, the length of Ireland!) on stationary bikes. The event was a resounding success with hundreds of onlookers/shoppers contributing as they watched the cyclists sweat the distance in the shopping mall. The fundraising total is currently €19919.15 and all the proceeds will go directly to the Renal Ward in the Children’s Hospital.

Visit West’s technical experts at the following fall conferences:

New Brunswick, NJ
http://conference.contractpharma.com/ 

The quality dynamic is a critical element to the successful marketing and commercialization of drug products. Relevant factors are associated with development time, drug product approvals, manufacturing efficiencies and patient loyalty. Strategies employed in early phases of drug development that consider delivery devices such as prefilled syringes and their components can mitigate risk to quality and position the product to meet needs throughout the drug product lifecycle. The return on investment is realized once a drug product is commercialized and has gained patient and caregiver loyalty. Patient loyalty stems from realizing ease of use, therapeutic benefit and confidence in the drug product; the caregiver will recognize availability of needed medicines, accurate dosing, administration options, increased safety and efficacy. The drug product manufacturer faces multiple challenges to meet these needs and can benefit from early investment in the right drug delivery system.

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Linda Lathrop and Alexis Kopp - West Pharmaceutical Services, Inc.

West’s 2012 Educational Series is a hit and we’ve still got two more to go.  Join us on September 13 in Gaithersburg, Maryland, as our subject matter experts present “Pharmaceutical Development Considerations: Injectable Delivery Systems Quality Planning.”

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Sometimes even the best training can’t change a dog’s energetic nature.

 

Watch for updates on Friend – coming soon!

Drug delivery devices and systems are becoming increasingly essential due to growth in injectable therapies driven by increased incidence of long-term diseases such as diabetes and auto-immune diseases. Many of these treatments require regular injections, often performed by the patient or caregiver in the home setting. Understanding the needs of these patients or caregivers is essential when considering designs for drug delivery systems.

Also, there can be a cost benefit when transitioning health care delivery from the hospital environment to the home environment or other health care facilities. Effective drug delivery devices and systems that enable a patient to self-inject can aid this transition. For example, it is now possible to transition from hospital IV to home-administered subcutaneous injection through the use of an electronic patch injector or auto-injector.

Pharmaceutical and biotech companies are working closely with drug delivery device manufacturers at an early stage to ensure that there is efficient development of an overall system to enable cost-effective drug delivery. Cost factors may include: the ability to move the product to market as quickly and effectively as possible; reducing in-process rejects due to breakage or lack of function; and the overall cost of quality, which has to be built into a system from the start. Reimbursement and end-user factors should be considered when designing drug delivery devices.
Prefillable syringes can aid in patient compliance, but most are still based around conventional glass syringes, which may suffer from challenges such as breakage, poor functional consistency, as well as potential interaction with sensitive biopharmaceuticals (due to silicone aggregation and  tungsten or adhesive sensitivity). Newer drugs, including those with high viscosity or that need to be administered in high concentrations, can present additional administration challenges.

Delivery systems companies such as West are introducing new materials for prefillable syringes, including break-resistant cyclic olefin polymers, such as Daikyo Crystal Zenith®products,and unique designs. These systems are not only manufactured from a novel polymer material that reduces the risks of breakage, but the dimensional tolerances, quality standards, and freedom from materials such as silicone oil, tungsten or adhesives ensure that the systems provide the combined benefits of a plastic with the features necessary to contain a sensitive biopharmaceutical.

For more information, visit westpharma.com or westPFSsolutions.com.

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Lloyd Waxman, Tadd Steeley and Vinod Vilivalam

Manufacturers of sterile drug products are confronted with increasing quality standards to produce defect-free products, reduce process/product variation and minimize product rejects. Parenteral drug products intended for injection must meet requirements set forth in the United States Pharmacopeia (USP) Chapter <1> Injections. Regarding foreign and particulate matter, “Each final container of all parenteral preparations shall be inspected to the extent possible for the presence of observable foreign and particulate matter in its contents. The inspection process shall be designed and qualified to ensure that every lot of all parenteral preparations is essentially free from visible particulates.” ¹

Particulate matter in finished pharmaceuticals can come from multiple sources such as the ingredients in the drug product, processing equipment or the container closure system. Manufacturers of sterile drug products should consider a means to reduce or exclude particulate matter and container closure defects in products. ²

 

Peggy Frandolig

First and foremost, there is a need to meet regulatory and insurance reimbursement requirements.  Also, there is a need to develop “new” products, rather than developing products where an equivalent brand already meets the market need.  Such “me-too” products have only a small incremental value.  Finally, it is always important for R&D to meet regulatory, compliance and quality challenges early in the development process – particularly with regard to suitability of packaging.  Early partnerships with packaging manufacturers can help to establish suitability and meet quality challenges throughout the product’s lifecycle.

Author:

Fran DeGrazio
Vice President
Fran.DeGrazio@westpharma.com  

At West, we are continuously expanding the ways we collaborate and communicate with our customers and business partners.  Social media is just one of the ways that we are improving the way we work together to make our communications more interactive.  You can find West on the social media “giant” sites LinkedIn, Twitter, and Facebook.  If you follow West on Twitter, you can stay informed about technology workshops where West personnel will be presenting at, news on product advancements, and new product launches.  

 

Beverly Prohaska
Vice President
Global Information Systems
Beverly.Prohaska@westpharma.com

In late fall, Dookie took a ride in an airplane, where Carol and Dookie got a tour of Chester County from a bird’s eye view.

Dookie also was able to attend church, ride the train and even catch a movie, but one of her favorite pastimes was riding in the car with Carol’s husband, Chuck. When riding in Chuck’s Mazda Miata convertible, Dookie places her front feet on the console, so she could face the back of the car with the wind blowing her ears. 

 

To learn how you can volunteer or assist CPL, visit www.k94life.org

At West, our mission is to develop and apply proprietary technologies that improve the safety and effectiveness of therapeutic and diagnostic health care delivery systems.  We believe our employees are our most important asset and that respect for the individual helps us to focus on providing outstanding value to our customers.  As a responsible corporate citizen, we comply with all applicable laws and regulations in each country where we do business, but we also expect continuous innovation.  Accountability is fundamental to our success, which is why West has long held a firm commitment to the environment. 

For any pharmaceutical manufacturer, landing on the FDA’s Good Manufacturing Practice (GMP) non-compliance watchlist is a headache of major proportions.  Recent citations from the FDA for issues such as metal particles in finished injectable products, contamination from stainless steel particulate in finished sterile products and poor aseptic technique have been issued to a variety of major manufacturers. Although these issues were handled quickly by each of the companies involved, the cost to both bottom line and reputation can be immense.

 

Dookie was not the only CPL dog in Volunteer Carol Cully’s household. Carol also takes part-time care of another CPL dog, Kitty. Dookie brings out the puppy in five-year-old Kitty by playing with toys and rough-housing. This summer, Dookie and Kitty joined the family on a trip to North Carolina.

To learn how you can volunteer or assist CPL, visit www.k94life.org

Subscribe to our news feed to get more updates about Dookie days at West!

 

West is pleased to introduce Customer Connection, West’s global customer portal.  You may remember Customer Corner, the predecessor to Customer Connection, which was our first generation customer portal.  Customer Connection extends our reach beyond the U.S. to our global customers.  Customers around the world can now retrieve technical documentation easily and there’s a newly-created library for official NovaPure component information.  In addition, sales reporting for customers outside the U.S. is planned for release in the near future.  This will allow us to provide customers with the ability to obtain order status on-line without having to call a West location to provide this information.

 

Beverly Prohaska

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Quality by Design (QbD) philosophy begins with the development of a Quality Target Product Profile (QTPP). The QTPP forms the basis for drug product formulation and process development in a QbD framework. A series of considerations should be made for the QTPP of a sterile product. Some of these considerations include the desired product performance based on the intended clinical setting, dosage strength and delivery mode, pharmacokinetic characteristics, drug product quality criteria, sterility and the container closure system itself, just to mention a few.

Six-month-old Dookie got a chance to see Chase Utley and the Phillies play at Citizens Bank Park during summer 2011.

 

Dookie weaved her way through the crowds and made it safely to her seat where she could watch the Phillies from the second deck first base line. Although she didn’t catch any foul balls, Dookie enjoyed her first Phillies game.

The West Ready Pack^® system provides a convenient, one-stop source for sterile vials, stoppers, seals and vial adapters.  This system is ideal for early clinical evaluation, R&D work and small commercial fills.  The sterile, ready-to-use format eliminates costly component preparation before use.  West vial adapters support the primary container closure system and allow you to optimize the drug delivery amount and minimize costly drug overfill.  All Ready Pack components are available for rapid order fulfillment and shipping.  For more information, view the Ready Pack video.  Contact West to learn how the Ready Pack system can provide a solution to your containment needs. 

In a previous post, my colleague Fran DeGrazio discussed lifecycle planning and the use of a single material for packaging components from development through commercialization. There has been a great deal of innovation around drug container materials. Although glass has been the traditional material of choice for drug containment, it has significant limitations including breakage, glass particulate, visual quality and functional performance. Glass syringe systems require siliconization to enable mechanical performance when used in a delivery system, and this material can interact with certain drug products, causing aggregation.

 

Graham Reynolds

 

Once a puppy is placed into the program, volunteers are required to go through two different levels of training. The first level includes the basic obedience commands - sit, down, stay and off. The second level is more in-depth, and includes teaching the puppy movement commands such as heel, front, back, side and up. The skill “up” will help the dogs learn to manipulate a light switch and open doors.