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Put on your mask and suit up as Production Manager, Adam Wrench takes us inside West’s Jersey Shore plant. Despite the familiar name, there’s no beach or boardwalk here. Rather, Jersey Shore is a town nestled Pennsylvania’s Allegheny foothills. At this plant, employees create numerous West components, including FluroTec® and Teflon® laminated 13- and 20mm stoppers. It’s the only West facility that includes two steam sterilizers for Westar® RU sterile ready-to-use components.
Continuous improvement initiatives are at the heart of the Jersey Shore plant’s processes, as Wrench describes how new gowning, goggles or molding upgrades are constantly being upgraded in the quest for higher quality. In employee interviews, workers share their personal ideals of keeping both West’s customers and the patients in mind.
They understand that we all are patients at one time or another in our lives, and the next drug packaging component they make could end up a part of your treatment, their own, or our families’. That idea fuels their drive to make the best quality products they can. These segments show both their dedication and understanding that – while they might be working on elastomer parts in a clean environment – it’s the real-life customers and patients that ultimately matter.
Wrap up your tour of the Jersey Shore plant and understand how quality is molded into every West component, forged through teamwork and close attention to processes with a vigilant eye toward excellence in production and procurement. It shows through the production flow to the customer and end users.
Standing front and foremost in biologic drug formulation is the optimization of safety and efficacy while ensuring quality and stability during manufacturing. Biologic manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Recently, the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges, including degradation.
West’s turns 100 today! A milestone that we are very proud of, and something few companies have the opportunity to celebrate. In honor of our 100th anniversary we are spotlighting our former President, Bill West, son of our founder Herman O. West.
Regulatory and market expectations constantly increase. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. One aspect of this is controlling particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. This blog describes approaches to control and measure particulate matter.
The Tech Group’s Keith Calvert recently contributed a three-part blog on metrology to Medical Design Technology. The following is from Part 2.
Cell therapies are stored at cryogenic temperature (approximately -180<sup>o</sup>C, vapor of liquid nitrogen). By providing container closure integrity (CCI) under this condition, primary package systems based on Daikyo Crystal Zenith<sup>®</sup> cyclic olefin polymer (COP) vials have a clear advantage over systems based on glass vials.
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