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Since the Technical Guideline on Compatibility Study of Chemicals and Elastomeric Closures was published by the National Medical Products Administration (NMPA, previously known as CFDA) in April 2018, it is essential for pharmaceutical companies to perform compatibility studies. However, for some domestic pharmaceutical companies that lack experience, it is unclear how to perform such a study. To address this, a series of trainings was planned by China National Pharmaceutical Packaging Association (CNPPA) – with the first held in December 2018. There were over 100 attendees from pharmaceutical companies, pharmaceutical packaging companies, NMPA-affiliated labs, and the third-party labs. The training received positive feedback from the participants.
Ms. Huo Xiumin, formerly responsible for drug product review at CDE (Center for Drug Evaluation, NMPA), shared her understanding of Technical Guideline …. She highlighted that compatibility studies are the responsibility of pharmaceutical companies, and that they should work closely with packaging components suppliers. Ms. Lynn Yao, Scientific Affairs Manager at West, presented on the overseas regulatory landscape for extractables and leachables, focusing on regulatory requirements, safety risk assessments, general approaches and case studies. The other presenters comprised experts from domestic pharmaceutical packaging materials manufacturers, pharmaceutical companies, and government agencies.
The West Scientific Affairs and Technical Customer Support (TCS) teams constantly monitor the regulatory landscape worldwide, in order to help customers navigate the regulations and select components that meet the unique needs of their drug products. For more information, contact an Account Manager or TCS representative.
The presence of particulate matter (PM) in parenteral drug products is a well-known challenge for pharmaceutical companies due to the potential quality and safety risks involved. In biotherapeutics, critical attributes related to efficacy, potency, clinical safety, and immunogenicity can be affected by PM.<sup>1-3 </sup><br />PM is defined as extraneous mobile undissolved particles (excluding gas bubbles) that are unintentionally present in solutions.<sup>4</sup><br />Several USP chapters describe the measurement of PM, namely:
As cell therapies are making their way to the market, safe and efficient transfer/delivery presents a challenge. Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. To address this, West has evaluated the suitability of its needle-free polycarbonate vial adapters (VAs) for withdrawing contents from vials from both a compatibility and performance standpoint.
West’s Ambassador Interns in Exton assisted the local West Chester Food Cupboard’s move into their new, larger facility. They packed and loaded 80,000 pounds of food at the Food Cupboard’s previous site, and then moved the supplies to the new facility. The West Chester Food Cupboard’s move enables the organization to serve even more clients, and was made possible through the Ambassador Interns’ help.
Today I am a Senior Vice President at Novo Nordisk one of West’s biggest customers. <br /> <br />A few years ago, I used to work quite closely with the West team. I clearly remember my first negotiations with West. Our interactions gave me the feeling that your team members had a deep understanding of our patients, the urgency of the particular matter we were negotiating about. I was under no mistake that their attitude and behavior towards my organization demonstrated a thorough wish to continue working together for many years to come.
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.
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