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Anabiotec is your reliable analytical partner throughout all your critical manufacturing milestones and progressing drug development stages:
Pre-clinical toxicity batches produced for animal studies to evaluate the safety and toxicological profile of the drug.
Validation batches produced to formally prove that the manufacturing process and validate that the product consistently meets pre-defined specifications.
Process Performance Qualification (PPQ) batches to demonstrate that the commercial manufacturing process is capable of reproducible commercial-scale production - a prerequisite for filing a Biologics License Application (BLA) or New Drug Application (NDA).
