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Research in the area of cell and gene therapies started almost 40 years ago, however recently there has been a been a surge of activity including landmark regulatory approvals for therapies treating chronic and rare diseases. In 2017 and 2018 the FDA approved the first two CART-T cell therapies for cancer treatment and the first two gene therapies for rare diseases. All four of these cell and gene therapies were approved under the FDA Accelerated Approval Program, aimed at expediting approvals for life saving drug therapies. These regulatory programs have the potential to shorten drug development as much as 1-3 years. Currently, there are more than 1,000 regenerative medicine clinical trials underway globally1, and the market is expected to grow rapidly over the next 10+ years.
As more of these life changing therapies are granted accelerated approvals and the speed of development increases, it is critical to plan for your packaging decisions early in the development cycle to avoid potential delays. West has partnered with many companies who have launched drugs via expedited approval pathways, and we understand the need for a solution to support you quickly through development.
Selecting a containment system that will protect your cell and gene therapy drug product across the cold chain is another major challenge that companies must consider early in the development cycle. West is a proven partner for the containment of gene therapies in the US and EU, with West and Daikyo systems used on four approved gene and viral therapies stored at -80°C.
West’s Ready Pack® containment system is an ideal solution for cell and gene therapy companies that need a proven containment system at cold temperatures and a fast delivery to meet the short timelines associated with accelerated approvals. The Ready Pack system includes stoppers, seals and vials, all supplied sterile and in small quantities for fast shipping to your site. West’s highest quality components are included in the Ready Pack system: Daikyo Crystal Zenith® vials available in multiple sizes; vision verified stoppers with FluroTec® barrier film; and West Flip-Off® Clean Certified Sterile seals.
With a proven regulatory approval pathway on four gene and viral therapies, West understands the needs of the market and will partner with you for the packaging and storage of low temperature therapies. We can provide you with a solution that includes both the packaging and technical expertise to move your cell and gene therapy quickly from small-scale development volumes through to approval and scale up.
Ready Pack, FluroTec and Flip-Off are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Crystal Zenith is a registered trademark of Daikyo Seiko, Ltd. Crystal Zenith and FluroTec technologies are licensed from Daikyo Seiko, Ltd.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.
Diane Paskiet, Director, Scientific Affairs, serves as co-chair for the 2014 PDA Packaging Conference: Pharmaceutical Packaging Systems – <em>Current and Emerging Practices, Technologies and Materials</em>, which will be held at the Washington Marriott Wardman Park, Washington, D.C. on May 20-21, 2014.
Diane Paskiet, Ph.D., Director of Scientific Affairs, will present “Biopharmaceutical Quality: Factoring Extractables into the Risk Equation” at Cambridge Health Insitute’s 14<sup>th</sup> Annual PepTalk 2015 conference on January 22-23, in San Diego, CA. The program, which was co-developed by Thomas Egert, Research Scientist, Boehringer Ingelheim GmbH & Co. KG, will focus on risks to quality posed by materials that contact biologics during manufacturing, storage and those associated with the final packaging configurations can pose risks to quality.
It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted.<span> </span>This comprises knowing of proposed changes as soon as announced, and being well prepared to accommodate them.<span> </span>Expected to be implemented by late 2018 – the functionality tests section of USP Chapter <381> (<em>Elastomeric Closure for Injections</em>) will be removed, and greatly expanded functionality tests will be incorporated in new USP Chapter <382> (projected title: <em>Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems</em>).<span> </span><p> </p>
Prior to joining West in 2015, I had a 24-year military career where I gained considerable experience in crisis management. During that time, I spent several years deployed overseas, spending long periods of time away from my family while serving in challenging environments. My service also included supporting the City of Philadelphia and surrounding counties during several declared States of Emergency. We spent many days and night running 24/7 crisis and emergency response operations including sending soldiers and vehicles on missions in support of local emergency services, first responder, and healthcare personnel.
<p><span>Recently, members of West and the University of the Sciences in Philadelphia, PA celebrated the 20<sup>th</sup> anniversary of the West Center for Computational Chemistry and Drug Design.</span></p>