A critical milestone to ensuring successful biologics production campaign is having a stable and repeatable process. Process validation is the documented evidence that a process can perform effectively and reproducible to manufacture a drug substance, intermediate, API, and also meet its predetermined specifications and quality attributes in preparation for commercial distribution.
VxP Biologics works hard to ensure that you have a scalable process that meets FDA regulatory requirements, reduces your costs going forward and maintains high quality standards.
We partner with clients to seamlessly integrate process design, process qualification, and continued process verification data and activities which may include:
- Process Validation Master Plan
- Process risk assessments
- Process performance qualification batches at the commercial scale
- Hold-time & Lifetime studies
- Extractables & Leachables assessments
- Related qualification and validation/cleaning studies