Module 9 2021

Raw materials – regulatory landscape

EP 5.2.12: (biological origin)

USP <143> Ancillary materials

GF/ Gytokines Antibodies and beads Enzyme and proteins Human and bovine serum Cell culture media Vector and plasmid Blood components

Anticogualants Cryoprotectants Antibiotics Consumables (plastics, tubes, bags)

Challenges ● EP and USP are not completely overlapping in terminology and definitions ● Inconsistent classification / labeling among suppliers ● Manufacturing processes and formulations considered proprietary information ● Guidelines for traditional Medicinal Products (biologics) does not translate directly to ATMPs ● Improved quality during development: comparability studies

Novartis Pharma AG- Business use only- not for further distribution

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