BIOLOGICS PROCESSES & PRODUCTS (MAMMALIAN & BACTERIAL ORIGIN)
DEVELOPMENT STAGE
Process development
Virus clearance (studies design)
Process characterization (plans / DoE design / reports)
Impurities characterization (studies design)
Process optimization
CMC strategy support
Bio-similarity pathway & comparability
Assay selection
QTPP set up & assessment
Leachable & extractables risk assessment
GMP MANUFACTURING
Processes transfer / establishment approach and plans
Scale up & process fit assessment
CDMO selection and evaluation
Process validation (plans / design / protocols / reports)
Assays validation (design / protocols / reports)
Development / transfer / establishment reports (preparation / review)
Cleaning validation
Manufacturability & financial viability assessment
PROCESS LIFE CYCLE MANAGEMENT
Process audits / troubleshooting
CMC review for clinical or BLA / MAA filing
CMC project management
Process scientific & regulatory justification
Assay life cycle management support
Statistical process data assessment