What is your product?

• mAb
• bsAb
• fusion-protein
• naked ADC
• other, specify

If bsAb, is your product produced by controlled Fab-arm exchange (cFAE)?

• Yes
• No

For details on cFAE, check: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8757479

Which services do you require?

• Developability assessment (testing process in 3L bioreactor through to drug substance)
• Cell line development(default is 1 x molecule)
• Process development (cell culture and purification)
• Formulation development
• Analytical development (include transfer/development of 1 x bioassay)
• Supply of indicative material for client use in MOA studies.
• GMP Cell banking(MCB/WCB)
• Supply drug substance for preclinical studies
• Supply drug product for preclinical studies
• Supply drug substance for clinical studies
• Supply drug product for clinical studies
• IND-enabling studies

• Protein characterization
• Stability testing, ICH compliant for accelerated and long-term conditions (DS and DP)
• In-use stability
• Cell bank testing
• Virus clearance validation
• Container Closure integrity testing

• CMC dossier in CTD format

• US
• EU
• China
• Other, specify

Abbreviations: GMP = Good Manufacturing Practices, MOA = Mechanism of action, MCB = Master cell bank , WCB = Working cell bank, IND = Investigational New Drug (interchangeable with Clinical Trial Application (CTA)), DS = Drug Substance, DP = Drug Product, CMC = Chemistry Manufacturing and Controls, CTD = Common Technical Document