Considerations When Selecting Components for Biosimilar Drug Products
As biosimilar development is expected to accelerate over the next decade, many customers are seeking packaging recommendations for these drug products. Because biosimilars are extremely sensitive to any changes from the innovator’s manufacturing and packaging processes, in every case it is important to understand the factors that affect the safety, purity and potency of the drug product as it relates to component selection.
From a packaging perspective, the most important concern for most biosimilars is protein aggregation. Protein aggregation may be caused by metal extractables, most notably tungsten in glass prefilled syringes (PFS), manganese in stainless steel PFS needles, and zinc in some elastomer cure systems. Metals can also be introduced from the vial or syringe through glass ion exchange. It is well documented that particulate is a known contributor to protein aggregation, which often enters the container closure system as an artifact of the component manufacturing process or through the use of silicone oil on elastomers or syringe barrels. Additionally, surface adsorption often plays a key role in protein aggregation, as many proteins can adsorb to the surface of a vial, syringe barrel or elastomer.
Using Quality by Design methodologies, West has designed components specifically for the use of biologic and biosimilar drug products. With low metallic extractable elastomers, FluroTec® film for reduced surface adsorption, subvisible particle specifications and 100% vision verification, West stoppers and plungers help reduce the risk of protein aggregation. Daikyo Crystal Zenith® vials and syringes are proven alternatives to glass that, when coupled with FluroTec barrier film applied to stoppers and plungers, do not require the use of silicone oil for lubricity. West’s safety and administration systems and self-injection technologies provide additional ways to help differentiate a biosimilar drug product from the innovator and competitors.
Please contact your technical customer support representative to see what data is available to better understand the role of packaging in biosimilar drug development.
Daikyo Crystal Zenith and Flurotec technologies are licensed from Daikyo Seiko, Ltd.