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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.
In recent years, an increasing variety of biologic drugs have been developed including vaccines, recombinant proteins, gene and cell therapies. In China, this increased demand will be reflected in a significant growth in the size of the bio-pharmaceutical industry. As a result, the Chinese government is increasing its investment.
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.
In recent years, an increasing variety of biologic drugs have been developed including vaccines, recombinant proteins, gene and cell therapies. In China, this increased demand will be reflected in a significant growth in the size of the bio-pharmaceutical industry. As a result, the Chinese government is increasing its investment.
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