Chemycal has been acquired by 3E
Learn MoreDiscover how Chemycal PRO helps you boosting your regulatory monitoring:
Broad information on use applied for: 4-tert-OPnEO is used in the manufacturing process for the Applicant’s Biological Drug Substance (BDS) abatacept. 4-tert-OPnEO is used for viral inactivation to ensure safety of the final drug substance as per regulatory guidelines. The Applicant is progressing R&D studies to find an alternative to 4-tert-OPnEO that is an effective viral inactivation agent that does not impact the quality of abatacept.
CONTINUE READING ON: echa.europa.eu2013 © MyChemicalMonitoring. ALL Rights Reserved. About Us | Terms and Conditions