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At West, our focus is on supporting the biopharmaceutical industry in qualification and commercialization of containment and delivery systems for injectable medicines. Selecting high-quality drug packaging that meets regulatory standards is essential to a drug manufacturer’s success. West’s top priority is delivering high-quality packaging products that meet the exacting quality standards and product specifications customers require.
West’s Global Technical Customer Support (TCS) Team is key to this effort – focusing on biopharmaceutical industry needs and partnering with customers throughout the process of selecting and qualifying primary packaging solutions and drug delivery systems. This includes a sound understanding of both the packaging requirements defined by the drug product and the regulatory standards. TCS also provides technical information and scientific data on West and Daikyo products, and facilitates interaction with other West services, e.g. West Analytical Services, to reduce drug product time to market.
Additionally, TCS is active in the biopharmaceutical industry, e.g., participation in industry groups, attending conferences and exhibitions, and delivering technical reports and presentations. This enables TCS to be constantly aware of the latest trends.
Broad technical knowledge, understanding of industry needs, and service excellence ensure that West TCS remains the scientific destination for customers.
Contact a Technical Customer Support representative today to see how West can support you bringing safe, effective drug products to the market.
Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult. In a recent <a href="http://www.nature.com/clpt/journal/v93/n2/full/clpt2012220a.html"><span style="color: #0000ff; text-decoration: underline;">paper</span></a>, Center for Drug Evaluation and Research (CDER) director, Janet Woodcock and her CDER colleague Marta Wosinska offered insight into the challenges CDER faces in choosing a course of compliance action when shortages of critical drugs occur. In the paper, CDER officials cited quality issues as the largest cause (56 percent) of drug shortages in 2011.
Focused on meeting customer needs in different markets and regions, West offers two types of washed Ready-to-Sterilize (RS) rubber closures: Regional-Washed RS and Westar<sup>®</sup> RS.
West is pleased to announce that it has become a multi-year foundation sponsor of the <a href="http://ymicfoundation.org/" title="Young Men In Charge Foundation, Inc." target="_blank"><span style="text-decoration: underline;">Young Men In Charge Foundation, Inc.</span></a> (YMIC). The program is dedicated to increasing the number of African American and Latino males in science, technology, engineering and math (STEM). West’s sponsorship will support the Foundation’s mission of integrating STEM exposure and mentoring with a focus on leadership, business and social skills.
Cell and gene therapies (CGTs) are becoming therapeutic modalities of choice for complex diseases like cancer, autoimmune and genetic disorders etc. In cell therapies, the cells are sourced either from the patient or a healthy donor and are genetically modified to fight diverse disease conditions within the body, whereas in gene therapies, malfunctioning genes in the cells are replaced with a working copy of the gene. With the advent of these advanced therapies, biopharma industry is facing many challenges not only in developing molecules against new hard to target conditions but also in the logistics of scaled up manufacturing. These therapies were in early stages during the past years and logistics of small batches that are often required for clinical trials were sorted out. As these therapies are becoming mainstream, scaling up or scaling out is becoming a challenge to reach more patients mostly due to intricacies of the manufacturing and fill/finish process that differs from conventional drugs. Gene therapy drug products are mostly filled in a traditional manner within an isolator in vials whereas for cell therapies closed processing and filling in either cryo-bags or vials is the current norm. However, as more therapies are getting approved along with the advent of allogenic cell therapies that will have relatively large batch sizes, more innovation, and new products are required for fast packaging needs as they tend to become less efficacious with increased processing times due to their sensitive nature.
Krishnendu Khan
Ph.D., Principal Scientist, WEST Pharmaceutical Services
At West, we actively foster an inclusive and collaborative culture for our team members where different views and perspectives are welcomed and valued. We are convinced that this approach brings forth innovation, learning and growth for our team members on a global basis.