FluroTec™ Barrier Films – Protecting Your Biologics

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.

Some common questions that arise frequently are:

• The biologic is very sensitive, can the system provide enough protection?
• The molecules are very complex, can the system maintain stability?
• The timeline for approval is very tight, will the system be approved?

These questions are especially challenging for a company that may have expertise in drug development, but not primary package systems.West can help. Based on extensive knowledge and a history of market leadership, West offers primary packaging systems that can address these and other questions. An example is the Ready Pack™ system, which comprises NovaPure^® stoppers, Flip-Off^® CCS (clean, certified, sterilized) seals, and Schott adaptiQ^® glass vials. In particular, NovaPure stoppers have a FluroTec™ barrier film in areas that contact drug product. This film, based on poly(ethylene tetrafluroethylene), provides added protection by reducing:

• migration of leachables from elastomer into drug product
• interaction of drug products with stoppers

Each NovaPure stopper is vision inspected using the Envision™ verification process to ensure low and controlled particle levels. Ready Pack system components are offered in quantities that support every development stage – from concept through commercialization. They may be a very good choice for biologics and biosimilars. For more information, contact an Account Manager or Technical Customer Service representative.

Ready Pack™, NovaPure^®, Flip-Off^®, FluroTec™ and Envision™ are trademarks and registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

adaptiQ^® is a registered trademark of Schott AG.