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Envision®, Westar® and NovaPure® are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
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.
One factor of parenteral drug product quality is the container closure integrity (CCI) of the primary packaging system. The interaction between the sealing surface of the elastomeric component and the vial is vital to ensure stability of the drug product over the shelf life. Therefore, defects found on the elastomeric component can increase the risk of failure or end-of-the-line rejects.
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
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.
One factor of parenteral drug product quality is the container closure integrity (CCI) of the primary packaging system. The interaction between the sealing surface of the elastomeric component and the vial is vital to ensure stability of the drug product over the shelf life. Therefore, defects found on the elastomeric component can increase the risk of failure or end-of-the-line rejects.
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