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Protein-based therapeutics are examples of the advancement of modern medicine and a revolution in drug discovery. Monoclonal antibodies (mAbs) account for the majority of biologic FDA approvals, and due to their low bioavailability by oral delivery means, they necessitate a shift to parenteral delivery. Hence, mAbs are typically packaged and stored in liquid or lyophilized format in glass vials, prefilled syringes, or cartridges for later injection.
Proteins are designed by nature to be interactive with and responsive to their environment and thereby highly subject to chemical and conformational changes. The same protein may have regions of hydrophobicity, hydrophilicity, positive charge and / or negative charge. This means that a protein can adsorb at nearly any surface or interface that it encounters. If it does so, the molecule may be unaffected or reversibly or irreversibly modified, potentially impacting the safety or efficacy of the drug product.
In optimizing the long-term stability of a protein therapeutic, it is important to consider the nature of every surface it may encounter. For example, glass surfaces can carry a negative zeta potential which may facilitate adsorption by electrostatic interactions. In a vial, prefilled syringe, or cartridge, aside from the container walls and elastomer surface, a therapeutic protein may also be exposed to thousands of air or silicone micro-interfaces during storage and shipping. Regardless of their nature, thousands of micro-interfaces in a formulation can represent a stability risk.
At West, we look to fundamentally understand the challenges of protein stability and develop the best integrated packaging and delivery systems to mitigate stability risks. With a comprehensive offering of analytical services, we are able to partner with drug manufacturers from pre-clinical evaluations through commercialization. If you wish to discuss your packaging options and discuss West’s analytical services capabilities, contact your Technical Customer Support representative or visit the West Knowledge Center.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.
At West, our goal is to partner with customers to mitigate risks of drug/packaging incompatibility, container/device and functional challenges. Although we consider critical quality attributes during development of drug packaging and delivery systems, there can be knowledge gaps of various interfaces based on the specific application of use, such as component-to-container, container-to-device, and container-to-drug.
A key element of West’s commitment to a safe and efficient delivery of drug products is staying abreast of industry developments, and being prepared to help customers navigate them. Recently Dow Corning introduced a new product - Dow Corning® 366 35% Dimethicone NF Emulsion.<br />
West’s Paul Cummings, Regional Director, Analytical Services, will present “Container Closure Integrity Testing of Glass and Polymer Containers from Ambient Temperature to -80°C” at the 2013 American Association of Pharmaceutical Scientists Annual Meeting and Exposition on November 10-14, 2013, in San Antonio, Texas.
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.
Even though glass syringes are predominantly used for primary containment of parenterals, the (bio)pharmaceutical industry continues to cope with certain limitations associated with glass containment systems. This is especially true when the drug is administered via prefilled drug-delivery systems such as auto-injectors or pens where glass cracks and breakage can be a serious risk for patients.