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Process Characterization

A set of documented studies in which operational parameter are purposefully varied to determine their effect on product quality and process performance.

Process Validation

The collection and evaluation of data from the process design stage to commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

Schedule Properly to Start Process Characterization and Process Validation

Process characterization study and process validation are important parts of the development of new drugs before BLA/NDA, and also a prerequisite for BLA/NDA.

Process characterization study usually starts after phase II. Process validation is generally carried out in phase III and completed before BLA/NDA.

As a professional CDMO, Bioworkshops has a strong process development team, which has strong knowledge accumulation and sufficient practical experience in process characterization and process validation activities, for the delivery of customer projects.

Process Validation: A Lifecycle Approach


  • Experienced

    Based on QbD principle, the team can provide extensive experience in CMC activities and have successfully delivered more than 10 projects to global IND. (China, America, Australia)

  • One-stop Solution

    Integrated services from DNA to IND and BLA

  • Full platform

    Complete facility and equipment for the needs of pivotal clinical drug production

  • Quality assurance

    Strong quality management system supported by experienced QA and QC teams

  • Compliance

    The RA team has more than 15 years of experience in regulatory affairs to support the PC/PV activities to meet regulatory needs

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