Challenge

A European biotech’s peptide program stalled at an Indian CDMO due to:
• Low crude purity (<65%)
• Unstable cleavage/deprotection steps
• Overloaded preparative HPLC columns
• Missed batch timelines, causing IND delays
The sponsor lacked visibility into root causes and needed independent intervention.

The intervention

• Conducted rapid CMC/Process audit to identify bottlenecks
• Mapped program to 3 specialised peptide CDMOs
• Selected a partner capable of a hybrid SPPS/LPPS fusion route
• Recommended modifications to resin loading, coupling temperatures, and purification window
• Implemented on-ground scientific governance and weekly milestone validation

Outcomes

• Achieved 98% purity at crude + final stage
• Completed 5 kg multi-batch campaign with reproducible yields
• Recovered 4 months of lost program time
• IND CMC module aligned with EU requirements

Impact

A failing program turned into a successful CMC module with predictable timelines and purity.

Why Aventiq Bio

Clients gain access to the founder’s prior experience in pre selection, audit planning, and CMC aligned outsourcing strategy, embedded into our proprietary checklist and decision matrix.