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July 23, 2020
The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.
Stevanato Group and Colanar have signed an agreement for lab scale fill/finish capabilities to study container closure systems at Stevanato Group’s US TEC in Boston, MA.
July 07, 2020
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.
July 01, 2020
Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
Safeguarding against microbial contamination requires rapid detection and innovative technology.
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
FDA can better monitor quality production of domestic versus foreign firms.
It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.
June 30, 2020
The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.
June 22, 2020
The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.