Process validation is the documented evidence that a process, operated within established parameters (identified during Process Characterization) can perform effectively and reproducible to manufacture a drug substance, intermediate, API, or medicinal product and meets its predetermined specifications and quality attributes in preparation for commercial distribution.

Cytovance® Biologics partners with clients to seamlessly integrate process design, process qualification, and continued process verification data and activities which may include:

  • Generation of a process validation master plan

  • Process risk assessments

  • Process performance qualification batches at the commercial scale

  • Hold-time studies

  • Lifetime studies

  • Leachable/extractable assessments

  • Related qualification and validation studies (equipment/facility/utility, cleaning, etc.)

  • Continued process verification and improvement