Risk management in clinical trials: A case study in API production

Developing a peptide or oligonucleotide therapy requires more than scientific innovation, it demands a robust chemistry, manufacturing, and controls (CMC) framework to navigate regulatory requirements, scale production efficiently, and manage risk. Without a structured approach, businesses face delays, compliance challenges, and increased costs.

This case study examines how Bachem partnered with a midsize biotech company on two critical projects to support their development pipeline. The first focused on refining peptide API production, ensuring regulatory alignment and scalability. The second tackled a more complex peptide manufacturing, identifying risks early and enhancing process efficiency. Both projects integrated Failure Modes and Effects Analysis (FMEA) to identify potential risks, enabling proactive mitigation strategies.

By embedding FMEA into CMC processes, drug manufacturers can enhance consistency, reduce setbacks, and confidently navigate the evolving landscape of peptide and oligonucleotide therapeutics.

Key insights:

• Adapting to a shifting peptide landscape – As demand grows, scalable and cost-effective manufacturing strategies are essential.
• Regulatory alignment – How a structured CMC framework ensures compliance with evolving guidelines.
• Risk management – The role of FMEA in identifying potential failure points early to prevent costly setbacks.

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