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Fran DeGrazio is an industry leader with over 35 years of experience in technical product development, quality, regulatory, marketing, and business strategy. Prior to retirement in 2022, DeGrazio was West Pharmaceutical Services’ Chief Scientific Officer and led a legacy of innovation through Quality by Design (QbD) and leading patient-centric elastomer components. Before her retirement I had the opportunity to discuss the development of 4040/40 gray formulation as the newest addition to West’s quality by design program the formula journey, the evolution and its importance in the marketplace.
1. What do West customers value the most?
“Customers value consistency and the ability to bring new products to market through innovation. Delivering high-quality products is not based on specifications alone; what our customers look for is a supplier that understands the broader picture by providing a consistent product whether it is brand new or something that has been delivered to market by West for many years.”
2. What is unique about West’s collaborations with customers?
As an industry leading supplier, West is focused on connecting with each customer to understand their needs and working to find solutions for their specific requirements. West has a growing portfolio of products using QbD principles under our NovaPure® brand. Our focus on identifying challenges and providing solutions has truly made a difference in the industry; QbD was originally not an expectation in drug manufacturing. Harmonized ICH Q8, Q9, & Q10 Pharmaceutical Development, Quality Risk Management, and Pharmaceutical Quality System were finalized in 20091. “Our strategy was to connect with our customers on their level to align with the changes in regulatory expectations. West needed to apply that same thought process and approach to the development and manufacture of our components. When we talk about QbD, it's all about improved product and process understanding and continuous improvement for drug products, and packaging later extending to combination products and drug devices through design controls. QbD and design control requirements are intended to demonstrate suitability for intended use and start and end with the patient in mind. Following both sets of standards helps to meet the industry expectations from a regulatory standpoint. Having our customers follow a QbD process for drug manufacture and development highlights the importance to have components developed with those same principles.”
Additional learning- The expectations for quality by design for pharmaceutical development can be better understood by reading the guidance documents accessed both on the FDA and EMA, and ICH websites just to name a few.
3. Fran you were leading R&D when 4040 was developed, why was it important to include a rubber formulation developed under quality by design principles?
“Our historical approach with the first NovaPure® products was to leverage existing rubber formulations, those were not in scope to change. West set out with a holistic approach to understand the process and product parameters that would allow a paradigm shift for a higher quality component.” NovaPure products are West’s highest quality complete offering that are more than just tighter specifications for particulate and AQL dimensions, rather NovaPure is based on scientific understanding, beginning to end. “We evolved then from process understanding to product designs and most recently, we found the need for a product developed with QbD beginning with the rubber formulation. To begin a new formula, we had to demonstrate to a much greater degree the decisions that were made around factors such as which materials were chosen, the optimization for quality, and the impact on the formulation physically and chemically. This strategy was the beginning of the development of 4040. The process of developing this formulation relied not only on, our experience in manufacturing capabilities at West, our optimization of materials and prior knowledge in each product, but also our experience with understanding customer needs.
4. Why is understanding the raw materials and the chemical profile of a formulation important to a customer?
“One of our positions was to understand and support with data a low extractables and potential leachables profile. For instance, each of the selected raw materials had a function in the way that this formulation has been developed. The selection of raw materials relied heavily on listening to and understanding customers’ needs. Critical functions and testing to understand the attributes that each raw material provided were essential in final selection.”
5. What do you feel were the biggest challenges in bringing a new formulation to the market?
“One of the biggest challenges is identifying the benefits of using a newer formulation and ensuring that in manufacturing and quality, the industry understands the uniqueness of these products. The control strategy associated with our products is essential in assuring consistency. Continuing to learn about each product and updating controls as part of continuous improvement is an important aspect as regulations and the industry shifts.”
6. How does the development of a rubber formulation using QbD principles create the foundation for what’s expected for the longevity of primary packaging configurations and potential long-term use in a combination product?
“QbD is best practice for drug development and complements the cGMPs of 21CFR Parts 210 & 211, which are applicable directly to the drug and its package. As for medical devices, one must follow the 21CFR Part 820 regulations (US example). For combination products there is a need to comply with both sets of standards. I can speak to best practices and what experts in the industry are saying about combination products. The industry expectation from a regulatory standpoint is for our customers to be following a quality by design process for drug manufacture and development so having an elastomeric formulation and component that follows a similar process makes a lot of sense. When we talk about quality and the broad design for our components this fits quite nicely into that paradigm of the expectations for a combination product.”
Click here for more information on our 4040 LyoTec® stoppers.
Reference:
LyoTec® is a registered trademark of West Pharmaceutical Services, Inc. in the U.S. & other jurisdictions.
Subvisible particulates (defined as those in the 0.1-10 micron range) are a growing concern for injectable drug manufacturers. The particles may cause aggregation, which can impact the drug product and create a potential safety risk for the patient. To help ensure product quality, the U.S. Food and Drug Administration recommends that manufacturers gain a better understanding of how subvisible particles impact the drug.
In recent years, there has been a shift in the pharmaceutical industry toward a Quality by Design (QbD) philosophy. To maximize a drug product’s safety and efficacy, pharmaceutical companies and their drug packaging and delivery partners are building new quality principles into the entire manufacturing process, from design and development to commercialization and administration. This scientific, risk-based QbD approach is fast becoming an essential strategy for bringing high-quality therapeutics to market quickly and efficiently.
The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs to provide a product that meets payer’s requirements and facilitating profitability in order to continue adequate business reinvestment.
<strong>NovaPure® Components Overview</strong><br /><em>By leveraging nearly 100 years of pharmaceutical packaging knowledge and implementing Quality by Design principles, West has developed the continuously improving NovaPure® elastomer portfolio which can be ideal for all drug product phases.</em>
In its 95+ year history, West has developed and marketed a very large number of elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention – a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
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