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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.
In March technical experts from both West and SCHOTT joined together to share insight on the current trends and challenges of the injectable drug market. The two companies held technical seminars sharing their knowledge and expertise related to component and container selection, as well as the integration of primary packaging for filling from clinical to scale up. <br />
Elemental impurities, such as arsenic, cadmium, lead and mercury are ubiquitous in nature. They are also toxic to humans and animals at certain levels. Because these elements are often part of mined minerals used in the manufacture of drug products and/or drug containment systems, they can have an impact on the quality of a drug. <br />
What’s the best strategy to create a holistic syringe-based combination product performance testing program? Start with the fundamentals - FDA Guidance Documents, ISO and USP considerations.
When choosing a resource for laboratory testing, pharmaceutical manufacturers face a difficult decision. Which is the better option – an independent facility or a supplier-affiliated laboratory?
<span style="color: black;">West is <a href="https://www.youtube.com/watch?v=42PhOvTdfRg"><span style="color: #0000ff; text-decoration: underline;">on the road</span></a> again, traveling more than 1,000 miles from our Jersey Shore, PA, manufacturing facility—where we visited during our first installment of <a href="https://westpharma.wordpress.com/2015/06/01/west-kicks-off-west-on-the-road/"><span style="color: #0000ff; text-decoration: underline;">West On The Road</span></a> —to the sunshine state, where we’ll be touring our state-of-the-art Clearwater plant.</span>
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