Example: air traffic controller
Biologics
Found 1 free book(s)Presentation - Manufacturing process of biologics
www.ema.europa.eu• Description: o Applicant’s commitment for the manufacture of the drug substance. o Manufacturing process and process controls. o Typically starts with a vial(s) of the cell bank, and includes cell culture, harvest(s), purification and modification reactions, filling, storage and shipping conditions. • Batch(es) and scale definition: o Explanation of the batch numbering …