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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.

Lyophilization (freeze drying) is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products. Absent water, degradation processes are greatly reduced. In any primary package system (i.e., vial, elastomer stopper, seal) for a lyophilized drug product, of utmost concern are leachables and volatile organic compounds that may migrate from the elastomer stopper into the lyophilized drug product, creating a risk to patient safety.

Fluoropolymer-laminated elastomer stoppers and plungers provide enhanced performance for container and delivery systems for parenteral drug products – especially sensitive biologic drug products. Among the many fluoropolymers available, West uses ETFE [poly(ethylenetetrafluoroethylene)] for its FluroTec^®–laminated products. Selection of ETFE was based upon ease of moldability and the following factors.

In the prefilled syringe system, the plunger is in contact with the drug product during administration and the drug storage period, which may last up to two years and can affect the long-term stability of the drug product.