September 22, 2021 - 11:00 a.m. EST
Peggy Frandolig, Technical Knowledge Manager, Scientific Affairs, West Pharmaceutical Services
Fran DeGrazio, Chief Scientific Officer, West Pharmaceutical Services
The evolving regulatory expectations for the pharmaceutical industry require early evaluation of sterile (or injectable) drug product packaging materials. Biologic drug products have seen increased growth and typically use parenteral drug packaging systems. The sensitivity of biologic/cell/gene therapy drug products drives the need to minimize the use of silicone and maximize the use of barrier films and coatings. Primary container component manufacturers have been working to improve these films and coating through multiple technologies. This webinar will discuss:
- Market insights of biologic/cell/gene therapy drug product sensitivities that establish the need for using barrier films and coatings.
- Scientific rationale for surface barrier technologies, comparison of processes, chemistry, and characterization techniques.
- Case study comparison of the impact of two elastomer closures with different surface barrier technologies on a model protein, Immunoglobulin G. including differences of silicon levels and protein particle aggregation.
October 5-6, 2021
October 12, 2021 - 10:00 a.m. EST - Registration Required
Olga Laskina Ph.D,Technical Account Manager
Abigail Hisler, Strategic Marketing Director
This webinar will focus on challenges that emerging biologic companies face early on in drug development and decisions you can make to mitigate delays and risks. Dr. Olga Laskina will provide an overview on packaging components that can protect your biologic, while eliminating potential barriers to success by ensuring you have a high-quality containment solution that can seamlessly transition you from preclinical development through commercial scale up. Abigail will provide solutions to common challenges faced by smaller companies that do not have the in-house expertise or resources to support the containment closure decisions they need to make. These available solutions will help reduce your risk and help maximize your speed to market, without costly delays. You need a partner that can help guide you through these challenges, allowing you to focus and make the best use of your resources.
Following the webinar, Abigail and Dr. Olga Laskina will host a Q&A session. If you work for a start-up or emerging company and are in the process of developing a biologic drug, don’t miss this opportunity to learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.
October 13-14, 2021
October 19-21, 2021
New York, NY
Wednesday, October 20, 2021
4:14-5:00 p.m. on Stage 3
Drive Robust Container Closure System Optimization for Risk Mitigation Through Big Data Analysis
October 25, 2021 - 10:00 a.m. EST - Registration Required
Jennifer Riter, Senior Director, Business & Technical Operations
Matthew Woods, Manager, Extractables and Leachables
Regulatory scrutiny of extractable and leachable (E&L) submissions have increased substantially over the years and particularly over the last 5 years. The Food and Drug Administration (FDA), United States Pharmacopeia (USP), and organizations such as the Product Quality Research Institute (PQRI) have published guidance documents and best practices concerning extractable and leachable studies for the pharmaceutical industry. This webinar will discuss these guidance’s and provide insight on how to perform studies and provide the FDA submissions that will their expectations.
November 4, 2021 - 11:00 a.m. EST
Diego Zurbriggen, Technical Account Manager, TCS, West Pharmaceutical Services, Inc.
Ed Trappler, President, Lyophilization Technology Inc.
Lyophilization is a complex, time intensive and often challenging process. It has become a common manufacturing practice for parenteral pharmaceuticals that are unstable in aqueous solution. The process itself poses critical demands on primary packaging. Often the selection of packaging materials is considered too late in the development cycle of a lyophilized drug product to fully evaluate these complexities. Choosing an optimized container closure early for your drug application can improve yield, reduce line downtime, influence lyophilization performance and speed time to market.
Different stopper designs and elastomer formulations have different chemical, physical and functional characteristics. In the case of a lyophilized product, the choice of stopper and vial combination contribute not only to the ease of manufacturing, but also to product quality and stability.
This free webinar will explore considerations of primary packaging selection and review potential risks based on chemical, physical and functional testing. The key discussions will be focused on the following:
- Recognizing packaging features that influence lyophilization process performance and manufacturability
- Understanding the impact of stopper design and elastomer formulation when choosing primary packaging
- Addressing common challenges faced when selecting primary packaging components for lyophilized drugs
- Learning about the complexities of freeze-drying, and the interrelationships of product formulation and primary packaging
November 9-11, 2021
June 8, 2021 -View OnDemand
Diego Zurbriggen, Technical Account Manager, TCS, NA West Pharmaceutical Services
Samantha Singer, MS, Scientist I/Project Director Lyophilization Technologies, Inc.
This webinar showcase a comprehensive approach to understand potential risks to lyophilized drug product quality based on chemical and physical performance testing. The discussion covers key considerations in the study design for manufacturability and packaging leveraging this analytical approach.
Key Learning Objectives
- An innovative approach to assessing inherent risks to lyophilized drug product quality
- Comprehensive analytical strategy through expanded study design
- Demonstration of the analytical strategy for a lyophilized preparation
May 20, 2021 - View OnDemand
Aaron Chapman, Ph.D, Program Manager, Commercial Technical Development – Oncology & Administration Systems
Peggy Frandolig, Technical Knowledge Manager, Scientific Affairs
Victoria Morgan, Director, Segment Marketing, Global Biologics
This webinar intends to educate attendees about the best decisions to make in early development which will proactively minimize risk, rather than have you managing risks later in development. Guidelines will be provided on how best to understand individual components as well as the interactions of those components with your oncology drug properties & sensitivities, giving you an increased chance of getting to market quickly.
Key Learning Objectives are:
- Understanding and establishing the drug needs (QTPPs) to enable long term packaging solutions to meet the patient’s needs.
- With regards your packaging, how to gain the technical expertise and knowledge to get you through BLA ensuring you know how your chosen packaging enhances your molecule, rather than detracts from it.
- How to use data to ensure compliance to USP<800> and CSTD use in the preparation of vial packed oncology drugs.
May 12, 2021 - View OnDemand
This webinar focuses on three big challenges pharmaceutical companies face as they consider life cycle management strategy and transition to a combination product.
Daniel Bantz, Manager, Scientific Communications, Self-Injection Systems
Jennifer Riter, Sr. Director, Business Technical Operations, Services and Solutions
April 13-15, 2021 -View OnDemand
This 3-day virtual workshop (4 hours per day) brings together industry experts and thought leaders in a unique forum to address a series of challenges and to learn practical strategies to mitigate risk in Combination Product development and commercialization.
Key Challenges & Risks to be addressed are:
- Translation of regulation to development execution
- Drug & Device Integration
- Device reliability & robustness
- Change & Lifecycle management
December 3, 2020 -View OnDemand
In November 2019, the International Council for Harmonization (ICH) Q12 guideline entitled Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management was finalized. This webinar will provide an overview of the guideline and will explain the Established Conditions (EC) discussed therein, as well as the applicable regulatory requirements. A deep dive into Post Approval Change Management Protocols (PACMP) and Product Lifecycle Management (PLCM) as tools to manage change will also be discussed.
November 12, 2020 - View OnDemand
Generic organizations will be required to continue to provide high quality in their drug manufacturing processes and bring their products to the market faster. They must also have a mindset that fosters operational simplicity and excellence to enable these requirements. With these needs in mind, this webinar will offer insight into the West’s AccelTRA® Elastomer Components Program
November 5, 2020 - View OnDemand
This webinar will explore why adherence, safety and quality of life are important for patients, and how these key enablers contribute towards positive outcomes. We will also discuss existing challenges, such as drug development, regulatory, patient accessibility, and how device technologies can further improve patient outcomes.
October 21, 2020 -View OnDemand
It’s been estimated that of the 35 million global healthcare workers that exist, 2 million of them suffer needlestick injuries each year, with approximately 500,000 of these occurring in the US. Of these, about 40% of cases go unreported each year. Due to these high numbers, regulations, laws and directives have been set to try to reduce needlestick injuries among healthcare workers. Consequently, some customers are now scrambling to understand what safety devices exist for their current and pipeline prefilled syringe (PFS) products. This webinar will discuss the need for safety devices and how the current COVID-19 pandemic is expected to accelerate adoption of regulations set to increase the use of safety devices to safeguard healthcare workers.
September 30, 2020 - View OnDemand
This webinar will place the oncology patient and the drug company at the heart of the conversation and will give situational awareness of the challenges both parties face, along with the proven solutions to help overcome these challenges.
September 17, 2020 - View OnDemand
This Webinar will explain the baseline requirements for elastomeric physiochemical and functional properties. Examples to illustrate qualification of components for intended applications will be included. A strategy for testing the entire packaging and delivery system inclusive of the drug product is essential. These USP updates are meant to increase patient safety by reducing risk through more thorough product understanding beyond component level testing, and these significant changes will be highlighted.
July 16, 2020 - View OnDemand
This Webinar, presented by Christa Jansen-Otten and Whitney Winters on July 16, 2020, explains the key critical product requirements, such as performance studies in prefilled syringes, container closure integrity, dimensional measurement results and particulate measurements that can be used to support delivery system assessment and implementation at pharmaceutical companies.