Regulatory Support and Quality Systems, CMC, IND, NDA, IMPD, Quality systems, cGMP, regulatory support

Highly Potent and / or Cytotoxic Compounds

Almac has responded to the growing need for manufacture and handling highly potent and / or cytotoxic 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. The goal is to ensure worker safety and product integrity while avoiding prohibitive costs of over-engineering.

Almac’s evaluation process begins with a thorough review, with the customer, of current knowledge of both the API and intermediates. This includes the appropriate Health & Safety, toxicology, and operations experts. Comparison to known compounds is used and when necessary, additional testing is carried out. Clear SOPs and operating instructions are generated based on this thorough review.

We have installed and certified containment equipment and were one of the first companies in Europe to receive SafeBridge certification.

Our containment and isolation facilities allow handling of compounds with OELs down to 0.1 µg/m3.  Isolators in a GMP Class 100,000 facility with pressurized anti-rooms, door interlocks and separate equipment / personnel movement are used for cytotoxic compounds.

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