API development is a core activity at Equateq, and we pride ourselves on our flexibility in being able to manufacture most pharmaceutical compounds in our dedicated synthesis plant. The plant is geared for pilot and kg-scale production of potent actives, both lipid and non-lipid.
All facilities and systems were installed in 1999 or later and have passed an FDA pre-approval inspection. The reactor systems have been designed for flexibility and use with corrosive chemicals, with glass lines, tantalum-clad condensers and PTFE piping. After synthesis and purification, packing is completed in a Class 100 clean room.
The API plant has been used for manufacturing contract APIs, and is also the location of our advanced lipid synthesis programme.
Typical reactions and processes:
- Grignards
- Halogenation/Sulphanation
- Friedel Crafts, alkylation and acylation
- Reductions, oxidations
- Recrystallisations
- Chiral resolutions
- Distillations
- Displacements
- Azeotropic separations
Specific equipment available includes:
Synthesis:
- 2 x 100 litre glass-lined reactors
- Overhead condensers (carbon block and tantalum clad)
- 20 litre Glass reactor
- Rotary evaporator
- S/S filter [expand "S/S"]
- Drying oven
Purification:
- Chromatography package
- Rotary evaporator
- 2 glass crystallisers
Filling:
- Laminar airflow booth
- Filter
- Drying oven
We are particularly well placed to produce novel compounds that include a fatty acid as part of the structure, such as:
- Synthetic triglycerides (e.g. tri-GLA)
- Diesters (e.g. EPA^^ArA)
- Monoesters (e.g. DHA^^OH)
- Salts (e.g. Lithium GLA)
- Other novel combinatorial compounds (such as ascorbyl GLA and meglumine GLA).