API Toxicology & GMP Supply

API Toxicology & GMP Supply

rapidd™ supplies API batches (NCE and peptide) from non-GMP material for preliminary toxicity studies through to a final larger scale GMP batch.

Typically for an NCE, the following are provided:

  • 10-50g Proof of Process Batch
  • Process Research & Development
  • 100g-1kg Non-GMP API Batch
  • 1-10kg GMP API Batch

Our experienced development chemists investigate the existing chemistry, verifying that the experimental procedures are fit for purpose prior to larger scale synthesis, or to quickly change them if they are unsuitable.

Essential process development is then performed with the aim of moving into scale up at the earliest opportunity, thus keeping timelines as short as possible.

Priority areas for development are to develop scaleable purifications for the API and key intermediates, to minimise reaction and workup volumes, thus making best use of vessel capacity, and to establish safe and cGMP compliant manufacturing processes.

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