Our Development module takes the lead candidates from the Discovery module through to synthesis for your evaluation, and includes both adsorbent and chromatography development. Alternatively, we can further develop your own in-house ligand. This module is performed using automated chromatography workstations and packed columns with initial investigation of non-bound, wash, elution and CIP steps.
Includes evaluation of:
- Base matrices
- Ligand synthesis method
- Immobilized ligand densities
- Attachment chemistry (e.g. spacer arms)
If required, we will include optimization of adsorbent manufacture and production of written methods in readiness for transfer to Astrea’s manufacturing facility.
Here, process conditions (i.e. load, wash, elution and CIP steps) are optimized to utilize the adsorbent in the most efficient way and maximize product purity and yield. This is performed in parallel to the Adsorbent Development.
An adsorbent cleaning and re-use study can also be performed as part of this work.
Once your candidate ligands have been developed, and you are satisfied after your in-house testing, the next steps are to move to the Deliver module, which includes Tech Transfer. This enables commercial scale adsorbent manufacture at our production facility, under GMP conditions. We can also deliver the custom adsorbent pre-packed in GMP Ready columns.