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Understanding extractables and leachables (E&L) is an essential element of determining the suitability of a packaging or delivery system for a drug product. Recently, PDA presented an interview with Dan Mellon, Ph.D., Pharmacology Toxicology Supervisor at CDER’s Office of New Drugs, discussing FDA’s approach to evaluating E&L information
In particular, seven issues were discussed that can negatively impact a new drug product application:
Further advice given was to be clear and detailed in how studies were designed and executed, to ensure use of proper measurement thresholds, and to consider at least three batches of drug product over time. Starting the E&L evaluation and consulting with FDA early are factors for success. E&L is a thrust area for West Analytical Services, having the expertise, staff, and facility, to design and execute E&L studies that meet FDA requirements on behalf of clients. For more on how West can help, please contact an account manager or Technical Customer Service representative.
In 2018, CNDA (National Drug Administration of China) issued Technical Guidance of Drug Compatibility with Rubber Elastomer Closures. This clearly demonstrates a focus on administrative guidelines for the safe and effective use of rubber components, which along with plastic and glass, are the most widely used materials in the packaging of parenteral drug products.
Cell and gene therapies are an expanding area with an expected growth rate of 24.7% over the forecast period of 2022-2030 .<sup>1</sup><br />Vial-stopper-seal combinations used as containment systems for these therapies need to maintain container closure integrity (CCI) for extended periods. Achieving CCI can be a particular challenge due to the low storage temperatures required: ultra-low (-80°C) for gene therapies and cryogenic (≤ -130°C, i.e., vapor of liquid nitrogen) for cell therapies.
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
The need to provide vaccines for the SARS-CoV-2 pandemic has presented the pharmaceutical industry with unprecedented challenges. Among them are accelerated timelines for development/approval and unanticipated volumes for manufacture/delivery. Ordinarily for a new drug product, there is ample time for selecting the primary package system and establishing component availability.
<strong>My greatest achievement is founding West without Borders*</strong><br />I’ve worked at West for 21 years! One of my friends approached me and said he would love it if I joined West. He kept telling me what a great company West was and eventually I agreed. I loved the job in the sales department because I got to work with a lot of bold personalities. I’m very outgoing and talkative and so are account managers.
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