Partnering
A CDMO partnership, from dossier to first commercial batch
Outsourced manufacturing works when both sides treat the technology transfer as the product. A walkthrough of how a partnership actually runs.
The contract is signed in a meeting room, but the partnership is made or lost in the technology transfer.
Stage one: the honest audit
A serious CDMO relationship starts with the client auditing the plant — capacity, quality systems, and the unglamorous details: water systems, airlocks, how deviations are actually closed. We would rather lose a prospect at this stage than surprise one later.
Stage two: transfer as engineering
Formulation, method transfer, and scale-up batches each generate data the receiving site must reproduce, not merely file. Success is defined numerically before the first batch is made.
Stage three: the routine that follows
Commercial supply then becomes a rhythm of batch schedules, release testing and rolling stability data. The relationship holds when both sides see the same dashboard.