Process development and manufacturing of an ADC payload from phase I to commercial
Axplora is an expert in ADC Payload manufacturing with over 15 years’ experience and more than 200 clinical and commercial cGMP batches produced. We safely handle compounds with very low OEL, below 30ng/m³/8hrs, and we can produce from 30g to > 1kg per batch.
Axplora was approached by a top 10 pharmaceutical company looking for a reliable long-term partner to manufacture an ADC payload, for a clinical phase I oncology project.
Highlights:
- Process robustness & characterization leading to 100% compliant batches
- Operational excellence program (OEP), implemented after commercial launch, for supply chain security, continuous improvement & cost reduction
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