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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

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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

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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

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Services biologics: Services
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