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By Your Side for Optimal Patient Outcomes – A Quality Perspective
In order to ensure the best quality drug product and optimal patient outcomes, it’s important for drug manufacturers to foster a collaborative effort with their packaging suppliers from the beginning – and that means starting with the patient in mind. Understanding patient needs and how that drug will be delivered, whether through one of West’s delivery devices or some other device, will help determine the needs within the West manufacturing process.
By working by the side of our customers early in the drug development process, we are able to clearly understand what the specific containment and delivery requirements are for their drug product and select the appropriate packaging and delivery systems and materials. These early conversations allow us to align capabilities across the globe to meet high-quality expectations throughout the entire manufacturing process.
For example, we need to consider the particle load throughout the supply chain – including other facilities, materials and processing involved in the production and delivery of the drug product – to ensure that we’re mitigating any additional burden that may exist later in the process that could impact the final quality. West takes an active role in supporting our pharmaceutical partners in this process, working collaboratively to develop a solution for the total supply chain.
In addition, quality standards are incredibly important when it comes to the combination of emerging drug molecules and delivery devices. Previous standards didn’t necessarily take into account the unique containment needs of biologics or other large molecule drugs. Additionally, old standards didn’t address the total drug containment and delivery system, but instead focused on individual components, such as stoppers and vials. It’s a completely different supply chain, and the standards need to be updated to address the needs around current drug molecules and delivery systems as well as future therapeutic offerings.
Working by the side of our customer, we can ensure that patients are always in the forefront of the production process, and that the quality of our manufacturing reflects the need for optimal patient delivery. When we understand better how our products will be used and what’s needed to align the capabilities, we can meet or exceed the quality expectations needed for our customers and ultimately the patient.
The number of biologic drug products marketed with an injection device has approximately quadrupled over the last decade. The growth in these drug therapies has been driven by several factors including new, self-administered therapies for chronic conditions such as rheumatoid arthritis and autoimmune diseases. In addition, injectable therapy is now being considered as a treatment for more conditions, including asthma and cholesterol problems.
When you think of injectable medication, a classic image may include a set of hands holding both a vial and a syringe to withdraw medication prior to injection. Advances in both drug products and self-injection options – including auto-injectors, pens and other self-injection devices – have helped to draw a new picture for injectable delivery.<br />
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.
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.
In 2012, the pharmaceutical industry will face many challenges, not the least of which will be the need to adjust research and development and business models to respond to the growing importance of specialty pharmaceuticals. Such products include sensitive biopharmaceuticals and the growth of biosimilars. Efficiency in manufacturing and the ability to meet critical compliance standards are a must to compete and meet today’s challenges.