Highly Potent API Manufacture
We have responded to the growing need for the manufacture and handling of highly potent compounds. The early development phase of a project sometimes creates a challenge for categorisation, and sufficient information is not always available to allow for a clear assessment of the exposure risks.
Our evaluation process begins with a thorough review of all knowledge of both the API and intermediates. This includes consulting with the appropriate health and safety, toxicology, and operations experts. Comparison to known compounds is used and additional testing is carried out where necessary. Clear SOPs and operating instructions are generated based on this thorough review.
With the installation of certified containment equipment, we became one of the first companies in Europe to receive SafeBridge certification. Our containment and isolation facilities allow for the handling of compounds with OELs down to 0.1 µg / m3.
We use isolators in a GMP Class 100,000 facility which features door interlocks, pressurized anti-rooms, and separate equipment and personnel movement.