Highly Potent API Manufacture
Ensuring worker safety and product integrity, while avoiding the prohibitive costs of over-engineering
We have responded to the growing need for manufacture and handling 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 current knowledge of both the API and intermediates. This includes 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.
We are one of the first companies in Europe to receive SafeBridge certification. Our containment and isolation facilities allow the handling of compounds with OELs down to 0.1 µg / m3. We use isolators in a GMP Class 100,000 facility, featuring pressurized anti-rooms, door interlocks and separate equipment and personnel movement.