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Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. Through the Integrated Solutions platform, West is ideally positioned to provide this data.
Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.
Primary container systems for storage and delivery of protein and peptide drugs (i.e., biologics), including vials and prefillable syringes, are typically made of glass or polymer, and include an elastomeric component (stopper or plunger). Proteins adsorb to most surfaces. Generally, the resultant loss of drug is not an issue since the amount adsorbed is on the order of 2-10 mg/mL, or not more than approximately 5 µg per 2 mL vial, or 13 µg per 5 mL vial.<br />
<p><strong>Applying metrology–the science of measurement–to the art of medical device design.</strong></p><strong></strong><p><strong></strong><em>The Tech Group’s Keith Calvert recently contributed a three-part blog on metrology to Medical Design Technology. The following is from Part 1.</em></p>
Particles in parenteral drug products continue to be an important concern. At the April-2017 AAPS Workshop <strong>Challenges and Patient Impact of Particles in Biologics</strong>, Fran DeGrazio, VP of Scientific Affairs and Technical Services, spoke on the topic: <em>Unique Considerations for Testing and Understanding Particle Loads for Primary Packaging Components.</em> <br />
One of the many unique opportunities West offers employees is the ability to participate in a short-term assignment program, known as ROADMAP (Rotational Opportunity Assignment Development Mobility Action Plan). Developed in 2015, ROADMAP provides employees with the opportunity to work at a different West facility for an extended period of time. The ROADMAP program is designed to encourage job sharing, job rotation, special projects, knowledge transfer and start-up opportunities to support the organization to further build global network and culture within West.
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