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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. West, through the Integrated Solutions platform, is ideally positioned to provide this data.
Our Integrated Solutions program brings together West’s primary packaging, device, analytical, regulatory and contract manufacturing expertise in a single-source solution. West can help you Simplify the Journey™ at any stage of drug development. Learn more by visiting our Integrated Solutions Program page or contact a technical representative today for additional support and guidance.
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 />
The United States Pharmacopeia (USP) continuously creates and revises standards in response to industry needs to keep up with the evolving pharmaceutical landscape. Recently, there has been a surge in revisions of USP chapters centered on the evaluation of packaging components for drug products.<br /><br />
On June 15, 2016, West’s contract manufacturing division—formerly known as The Tech Group—attended Medical Design & Manufacturing (MD&M) East in New York City. This annual event is especially insightful, as it offers access to six additional industry expos–EastPack, ATX (Automation Technology) East, Atlantic Design & Manufacturing, PLASTEC East, HBA Global, and Quality Expo. Show attendees discovered the latest innovations, new materials, and state-of-the-art manufacturing processes from among 900 suppliers.
Gene therapies are stored and shipped at ultra-low temperature (approximately -80<sup>o</sup>C, either in a refrigerator or on dry ice). This provides a challenge to the primary package systems in maintaining container closure integrity (CCI), especially systems comprising glass vials and elastomer stoppers. These materials have different coefficients of thermal expansion. Upon cooling from room temperature to ultra-low temperature, they contract at different rates; this may lead to gaps and CCI loss.
In today’s rapidly evolving business landscape, the need for skilled workers has never been greater. West has risen to this challenge by not just hiring talent, but also molding it through effective apprenticeship programs in collaboration with the Pennsylvania College of Technology (Penn College), a special mission affiliate of Pennsylvania State University. These initiatives have proven to be a resounding success.