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