Our Delivery module takes your custom adsorbent either developed with Astrea or your own in-house adsorbent and transfer the manufacture to our plant on the Isle of Man.
Tech Transfer & Validation
This involves the production and evaluation of three conformance batches of custom adsorbent at Astrea’s manufacturing facility. Validation batches of custom adsorbent are then supplied to the end user, along with a validation plan and summary report.
Regulatory Support Package
A comprehensive support package of information will be developed and supplied to the end user to assist registration of the purification process with regulatory authorities. The regulatory package will include information derived from the following studies:
- Ligand leakage study
- Stability trials
- Toxicology studies (if required)
Contract Adsorbent Manufacture
Partnering with Astrea provides the following key benefits:
- Over 30 years’ experience of adsorbent manufacture.
- Established ‘GMP’ standard manufacturing.
- ISO 9001-2015 accredited quality management system.
- Controlled production environments (Clean rooms – ISO7 & 8).
- Range of vessel sizes to enable production of batches from 1 to 1000 litres.
- Process development and validation to ensure consistent product performance.
- Established process applications and multiple large-scale users.
- Product and regulatory support.