Blogs

There is no doubt biologics and biosimilars will remain one of the hot topics in 2021. This is due to the pandemic period of SARS-CoV-2 and the innovative treatments and vaccines that are under development at accelerated speed. Several questions can arise regarding selection of the proper primary package system for a biologic/biosimilar.

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.^1.

West is pleased to announce that we’ve recently expanded our Online Store offerings to include a 20mm NovaPure^® Ready Pack™ lyophilization stopper, adaptiQ^® vials from SCHOTT and Ready Pack™ Flip-Off^® CCS (Clean, Certified, Sterilized) seals. West’s Online Store is a one-stop solution for access to small quantities of some of West’s highest quality products, in stock and available ready-to-use in convenient small packs. Depending on their product needs, shoppers can now purchase a complete vial containment system with the option of selecting either Daikyo Crystal Zenith^® or adaptiQ glass vials.

Our team will share their expertise and introduce several new and innovative pharmaceutical containment and closure offerings during the Paris Pharmapack trade show.

The FDA recognizes that compounded drugs serve an important role for patients whose medical needs cannot be met by FDA-approved drugs. However, compounded drugs are not approved by the FDA and therefore, have not been evaluated for safety or efficacy. Poor compounding practices or unsuitable manufacturing conditions can lead to serious adverse effects, or even patient death. Over the past few years, the FDA has taken significant steps to modernize and clarify policies related to the quality of compounding in an effort to ensure continued access to compounded drugs, while also protecting patients from the risks of contaminated or otherwise harmful products¹. FDA Draft Guidances^{2, 3} help to clarify applicable regulatory requirements and specifically address the use and handling of container closure systems.

As of 2018, over 4,000 new injectable drug products are in development world wide – a great many of these in small settings such as universities, medical research institutes, and small companies.  These efforts need the ready availability of high quality, sterile packaging products in small volumes for developmental and clinical phases.