Biologics Raw and Ancillary Materials Standards

Buy direct from USP:

• Collagenase I
• Collagenase II
• Trypsin Recombinant Porcine
• Fetal Bovine Serum
• Protein A
• rProtein A
• rProtein A, C-Cys

See all biologics Reference Standards

For associated documentary standards, please visit USP-NF Online (note: you will need a log-in to access specific standards)

• <89.1> Collagenase I 
• <89.2> Collagenase II 
• <89> Enzymes used as Ancillary Materials in Pharmaceutical Manufacturing
• <90> Fetal Bovine Serum Quality Attributes and Functionality Tests
• <130> Protein A Quality Attributes

Access USP-NF Online

• Advanced Raw Material Control: Rapid ID and Raw Material Informatics (On-Demand)
• An Attribute Focused Approach to Identify and Control Raw Material Variability (On-Demand)
• A Combination of Strategic Planning and Technical Assessment to Overcome Raw Material Management Challenges (On-Demand)
• Practical Considerations for Gamma Irradiation of Serum (On-Demand)
• Viral Safety of Raw Materials Used in Production of ATMPs (On-Demand)
• Raw Materials Quality: Requirements, Limitations, and Recommendations (from an Ancillary Material Manufacturer’s Perspective) (On-Demand)
• Regulatory Considerations for Raw Material Qualification and Related Controls for Biotechnology Drugs (On-Demand)
• Raw Material Controls for Biologics: Inspectional Experience (On-Demand)
• Applying Online Analytical Tools to Characterize Cell Culture Medium Preparation (On-Demand)
• Impact of Elemental Impurities in Biologics development and Manufacturing & Risk Management for Control Measures (On-Demand)
• Strategy to Determine Impact of Complex Raw Material Variability on Process Performance (On-Demand)
• Qualification of Raw Materials and Cell Substrates for Biomanufacturing (On-Demand)
• Standards and Best Practices to Support Trace Metal Quantification in Cell Culture Chemically Defined Media and Hydrolysates (On-Demand)
• Regulatory Considerations for Setting Smart Starting Material Specifications (On-Demand)