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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.
Learn more by contacting an Account Manager for additional support and guidance or visit our Online Store for easy ordering and fast delivery of West’s Ready Pack system.
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.
Gene therapies are developed by modifying a person’s genes and are often targeted to treat complex and chronic diseases. Due to advancements in science and research, gene therapy is positioned to transform treatment options for patients who are living with these incurable diseases. There is a growing pipeline of gene therapies globally, with 352 global trials underway at the end of 2019, up 12% from 2017.<sup>1.</sup>
It is an exciting time to be in the Cell and Gene therapy industry. The astounding growth and development we have witnessed in the cell & gene therapy industry over the last decade is bringing life-changing therapies to the patients who have been so anxiously awaiting them. <br /><br />At the same time, as with any new drug class, challenges that may not have been considered during the drug development phase may suddenly show up and stand in the way of overcoming that last hurdle: Packaging and delivering your precious new molecule to the patient.
Competition is increasing in the biopharmaceutical pipeline due to a growing number of new entrants, more players are bringing their drug all the way to market and many companies are utilizing accelerated development pathways, making it an even faster race to market. If you are like many other newly formed biotech companies, you’re doing your best to manage many activities critical to your success with limited resources, all while trying to accelerate your path to market.
Biologics is a rapidly growing market, with a robust R&D pipeline bringing innovative therapies to treat patients. Today, there are 4,000 more active biologic programs in the pipeline compared to 2015, with biologics development programs growing 2.5 times faster than small molecules. New entrants into the biologics market are driving this rapid growth. As of 2018, emerging companies represented 84% of all early phase research.<sup>1</sup> Not only is this segment driving R&D growth, but they are having commercial success in bringing their drugs to market. In 2018, 65% of new drugs launched were patented by emerging companies.<sup>1</sup>
In recent years, an increasing variety of biologic drugs have been developed including vaccines, recombinant proteins, gene and cell therapies. In China, this increased demand will be reflected in a significant growth in the size of the bio-pharmaceutical industry. As a result, the Chinese government is increasing its investment.
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