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Small Volume Parenterals (SVP): Regulatory, Chemistry and Toxicology Considerations Agenda • • • • Case Study Overview Regulatory Perspective Chemistry Findings Toxicological Impact Case Study Overview • Megavac Bio, a large US-based pharma/biotech company. • Vaccine, “Prevent” marketed in the US, Europe and Asia, since 1980 • Market shift from US and Europe to Asia, where 70% of units are sold • Due to market shift and increasing domestic production costs, there will be a shift in production from the US to a contractor based in Asia. Case Study Overview • The drug formulation will remain the same, as well as the production process • Primary packaging components will be changed • Current CCS • • 3mL glass vial (13mm finish) 13mm rubber closure (blend of chlorobutyl and natural rubber) • To change • • Container—to reduce breakage and package weight Rubber Closure—current rubber formulation will not meet current USP <381> Elastomeric Closures for Injections Case Study Overview • New CCS • 3mL COC vial (13mm finish) • 13mm bromobutyl rubber stopper *Both the COC vial and rubber stopper will be made in Asia. Case Study Overview Supply Chain Issue • Packaging material quality and variability • Supplier contracts and Change Control issues • Finished component (vial & stopper) quality and variability including composition and dimensional issues Case Study Overview Vaccine DP – CCS Compatibility Issues • • • • Particulates Extractables/Leachables Water vapor and oxygen transmission through COC vial Migration of label adhesives/inks and other label materials through COC vials into DP • Migration of wooden pallet fungicide byproducts, such as 2,4,6-tribromoanisole, into COC and rubber polymers.