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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.
<span style="color: #000000;">Save the dates for West’s 2012 Educational Series. Join us as our subject matter experts present </span><strong>“Pharmaceutical Development Considerations: Injectable Delivery Systems Quality Planning.”</strong>
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.
At West, we are committed to attracting and retaining a diverse and inclusive workforce. We understand that diversity is key to our success and know that a diverse workforce leads to greater innovation, more opportunities, better access to talent and stronger business performance. We encourage a culture of mutual respect, where everyone feels valued and respected and can bring their authentic self to work every day, helping to foster an environment that enables our team members to stay energized, focused and committed to doing their best.
On August 6 and 7, 2019, USP hosted the Second Annual Workshop to explore current trends, initiatives and regulations for quality compounding. Members of the West Pharmaceutical Services, Inc. (West) Scientific Affairs and Strategic Marketing departments participated in the USP workshop and gained valuable insight into the key elements of the FDA’s efforts to improve the quality of compounded drugs.
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