June 20th 2025
Some of the companies that received American samples, FDA said, are partially owned or controlled by the Communist Party in China.
EXO Biologics and ExoXpert Reach Two Critical Milestones that Advance Exosomes
December 3rd 2024EXO Biologics and its subsidiary, ExoXpert, have received GMP certification of a European exosomes manufacturing facility and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.
Non-Animal-Derived Reagents for Endotoxin Testing
November 27th 2024In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the new chapter, Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents
Discussing Proper Analysis of HCPs in Biomanufacturing (AAPS PharmSci 360)
October 24th 2024The importance of proper analysis of HCPs in the biomanufacturing process was discussed by Shawn Li, principal scientist at Merck & Co., known as MSD outside the Unites States and Canada, at AAPS PharmSci 360.
Strategic Changes to a Legacy Cleaning Approach Result in a More Sustainable Process
October 11th 2024In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.