Home » Biologics CDMO » Process Characterization & Process Validation

Service Highlights

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    Fast Process Characterization

    PC completion in 4 months

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    Global Quality System

    100+ client audits globally

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    Prompt Reply

    E-mail response within one business day

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    Favorable Unit Cost

    2,000 L GMP manufacturing price <$100/g*

*DS unit price (a. Fed batch process in 2000L SUB, b. 7g/L, 70% yield, c. annual batch number≥ 20 batches), including FFS and material cost

Work Contents of Fast Process Characterization

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    CPP/CQA Evaluation

    • Data collection & risk assessment
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    Upstream Process Characterization

    • Scale-down model establishment and validation
    • Design of experiments
    • Worst-case condition confirmation
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    Downstream Process Characterization

    • Scale-down model establishment and validation
    • Design of experiments
    • Worst-case condition confirmation

GenScript ProBio offers 2 process characterization (PC) services: fast PC and standard PC, to meet the needs of various projects. Fast PC is appropriate for products with accelerated approval pathways or monoclonal/symmetrical bispecific antibodies in liquid formulation. Standard PC is appropriate for all products, particularly complex molecules such as proteins and asymmetric bispecific antibodies.

Works Contents of Process Validation

PPQ Relevant Validations

  • 3 batches of commercial scale manufacturing
  • DS/DP stability study
  • Purification intermediate stability validation
  • Validation of mixing effectiveness
  • DS/DP transportation validation
  • PPQ DS characterization
  • EOPC/UPB/VC test
  • Process related impurities study

Other Validations

  • Cleaning validation
  • Media/buffer shelf-life validation
  • UF membrane/resin lifespan validation
  • Post-sterilization material retention time validation
  • Consumable/packaging material related validation
  • Cell bank related validation
  • HCP coverage test
  • In-use compatibility study

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