API Development & Manufacture, API, API Synthesis, Active Pharmaceutical Ingredients, custom synthesis, custom manufacturing, cGMP manufacturing, CMC, pilot plant, process development, CMC

API Development & Manufacture

Chemical Development and Active Pharmaceutical Products Manufacture

Almac’s organic and analytical chemists deliver a wide range of projects from one-off impurity synthesis to many-step, complex GMP pharmaceutical product manufacture. Our chemists stay with a project from early route screening to commercial manufacture to ensure efficient cost-effective scale-ups. Many of our APIs also stay on-site for Drug Product Manufacture.

Preclinical and Early Clinical Development
Skilled organic chemists apply their talents for rapid supply of both APIs and support products (reference standards, impurity markers, etc) for early development.

Late Clinical and Commercial Supply
Almac provides seamless scale-up to late clinical and commercial supply. Manufacture is optimised as appropriate for development phase. Multi-purpose GMP plants provide cost effective manufacture.

Potents & Cytotoxics
Almac has responded to the growing demand for highly potent and/or cytotoxic product synthesis. Isolators and the highest level of worker and product protection are utilised.

Antibody Drug Conjugates
The combination of complex peptide synthesis, site-specific conjugation, biomolecule handling and small molecule expertise provides Almac unique qualifications for development and delivery of ADCs.

Project Management and Regulatory Support
Project management is critical for effective execution and delivery of our  customers’ complex projects.  Our project managers are experienced scientists, working with clients to anticipate and respond to sometimes changing project priorities.

Almac has an excellent regulatory history with regular inspections by all appropriate regulatory bodies (FDA, MHRA) and our clients.

Almac Advantage

Experience

Over 100 highly experienced chemists and analysts

Facilities
  • 5 chemistry labs
  • cGMP API manufacturing facility
  • 3 analytical labs
  • Dedicated GMP containment and microniser facility
Supporting Services
Flash replacement image