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.
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.
· Identification of critical quality attributes (CQA)and critical process parameter (CPP) · Risk assessment · Control strategy · Scale down model development and qualification · Process characterization/ DoE study in lab scale
· Commercial scale PPQ operation
· Facility and equipment qualification · Commercial scale manufacture operation · Commercial scale analytical method validation · Sterile filtration membrane validation · Packaging system validation · Clean validation · Membrane and resin lifetime validation · Stability study · Transportation condition qualification
ExperiencedBased 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 SolutionIntegrated services from DNA to IND and BLA
Full platformComplete facility and equipment for the needs of pivotal clinical drug production
Quality assuranceStrong quality management system supported by experienced QA and QC teams
ComplianceThe RA team has more than 15 years of experience in regulatory affairs to support the PC/PV activities to meet regulatory needs
