Determining Protein Oxidation Induced During Fill-Finish Operations
The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.
Residual hydrogen peroxide (HP) from the vapor-phase HP (VPHP) isolator decontamination process can diffuse into drug product, potentially resulting in significant protein oxidation and thus impacting product quality. The effect of absorbed VPHP on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide and the stability of the lyophilized product was studied for up to six months.
Download
Pharmaceutical Technology’s 2014 Bioprocessing and Sterile Manufacturing eBook.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Entering New Domains for 3D Printing of Drug Products
April 6th 20253D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.
