API Development & Manufacture
Our technical expertise and extensive facilities enable us to offer integrated API contract manufacturing solutions through all stages of the drug development lifecycle. We are fully supported by dedicated analytical and regulatory teams.
We offer numerous support capabilities, including:
• rapid implementation of chromatography for purification
• containment equipment for potent compounds
• micronisation to control particle size
Our dynamic team successfully address many complex project challenges, and implementing our on-site biocatalysis technology expertise is one example of our responsive solutions.
Early clinical phase
We have significant experience in the first time scale-up of APIs. Starting with the medicinal chemistry route, our knowledgeable chemists can quickly identify the most pressing parts of the chemistry to develop. Our chemists work closely with our development analysts and production teams to ensure that controls are appropriately embedded into the process IPCs, intermediate specifications and processing instructions. The salt form and polymorph landscape are explored within our physical sciences teams and drive the development of the API isolation process. Particle size is controlled through our micronisation suite.
Late clinical phase
We have an established reputation for developing processes for late clinical stage. Our extensive experience lies in taking processes from inception through to process validation, both in small molecule chemistry and peptides. As an API moves from early clinical phase towards late clinical phase, the emphasis of the project changes. Whereas in early clinical supply, a lean fit-for-purpose approach is appropriate, other factors start to dominate when moving towards late phase, particularly process efficiency and knowledge. We strategically integrate the principles from regulatory guidelines (FDA, ICH, USP), such as risk management and quality by design, as a basis for development and manufacturing strategies.
Highly potent manufacture
We have responded to the growing need for manufacture and handling highly potent compounds, including cytotoxics, in a dedicated and separate contained manufacturing suite. Our evaluation process begins with a thorough review of current knowledge of both the API and intermediates, including 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 pressurised anti-rooms, door interlocks and separate equipment and personnel movement.
Why choose Almac for API development & manufacture?
Our reputation and strength in API development and manufacture precedes us within pharma and biotech companies who seek integrated drug development solutions from molecule to market. Our technical expertise and extensive facilities enable us to offer integrated API contract manufacturing, on one site through all stages of the drug development lifecycle. Complementing our API services, we support a world leading biocatalysis platform to secure the supply of biocatalysts for non-GMP and GMP manufacturing projects alike. Additionally our services are supported by specialist departments, including 14C radiolabelling, preformulation, solid state services and analytical support, ensuring the needs of your drug development programme are fully met whilst maintaining our track record of saving time and cost.
“We retain our business with Almac because their technical approach, expertise and communication through project management cannot be matched.”