Every stage below is executed by the same team, under the same quality system, so your data package reads as one continuous story — not four vendors stitched together.
Feasibility & early process
Optimisation & qualification
Tech transfer & batch production
QC release & regulatory support
We start where your process is today — often a flask, a small bioreactor, or a hand-written protocol. The goal at this stage is a documented, repeatable process and an early analytical picture of what you're making.
The bench process is optimised and translated into a scale-down model that predicts GMP-scale performance. Analytical methods are qualified so release testing is meaningful, not just available.
A structured technology transfer moves the qualified process into the GMP suite. Engineering runs confirm the transfer before GMP batches are produced under full batch records, deviation and change control.
Release and stability testing generate the data package your regulator needs. CoAs are authored by the team that ran the batch, and CMC documentation is prepared to support your clinical trial application.
Start-ups that move between vendors between stages usually re-run comparability studies, re-write documentation, and re-qualify methods — each time losing weeks to a hand-off that shouldn't exist. Carrying the same process and quality system across all four stages removes that gap entirely.
Tell us your current stage and target milestone — we'll map which of the four stages you need, and which you can skip.
Map your pathway