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Critical quality attributes (CQAs) of biologic drug products can be affected by multiple factors throughout the product lifecycle, including the container closure and delivery systems. Diane Paskiet, Director of Scientific Affairs at West Pharmaceutical Services, discussed containment and delivery system compatibility with biologic drug products along with regulatory considerations in her presentation Establishing Safety of Container Closure and Delivery Device Systems at the PepTalk 2017 conference. Evaluating potential impacts early, holistically, and throughout bioprocessing can facilitate decisions at each step that will minimize risks to CQAs and safety.
A number of risks to biologic drug products can arise from poorly understood packaging materials, components, or systems. Examples of risk include: presence of elemental impurities or other leachables, particulate contamination, product aggregate formation, and compromised container closure integrity. Taking a scientific approach to fully understand the chemical characteristics of packaging materials and subsequently evaluating component and system safety in both simulation and actual conditions of use studies will enable the most robust assessment of potential risks to biologic drug products. The presentation also provided an update on the efforts of the Leachables and Extractables Working Group of the Product Quality Research Institute (PQRI).
Please click here to view Ms. Paskiet’s presentation. It is also available in the Knowledge Center of our website.
More information about PQRI can be found here.
According to the Code of Federal Regulations Title 21 Food and Drugs Part 211.94(a) Subpart E Control of Components and Drug Product Containers and Closures, drug containers must not react or add to a drug product in a way that alters the drug’s safety or quality.
“There is no disease so rare that it does not deserve attention.” This statement from Orphanet, a portal for rare diseases and orphan drugs, makes that point very clearly. For patients suffering from a rare disease, orphan drugs and the special attention that they receive during the drug review and approval process can be both life changing and saving.
Our team in Israel, along with the rest of the world, have had a very challenging time due to the COVID-19 pandemic. In Israel, charities supporting youth in need have found this time to be particularly tough. As a result, the team came up with a novel and environmentally friendly solution to help support some of the youth in their local community.
<span>Finding the perfect home can be a challenge. Upfront research could be the difference between selecting a home with a dry basement, or one with a faulty foundation. And once purchased, failure to address small problems can result in big losses. While making a larger investment upfront may be difficult, it pays off in the long run.</span>
Several of West’s experts will be featured speakers at The Universe of Prefilled Syringes and Injection Devices organized by 2013 PDA Europe, which will be held November 5-6, 2013, in Basel, Switzerland. West’s representatives will report on the latest trends in the world of prefilled syringes and innovations in the field of self-injection devices.
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