Coupled with the synthesis of process intermediates and GMP raw materials, we also offer cGMP manufacturing of your API in small scale and in production scale. AMRI handles small-scale API production critical for discovery and development, GMP scale in Albany and manufacturing at our global API facilities. We handle your cGMP manufacturing needs seamlessly from grams to metric tons — and through all phases of clinical trials — without the need for technology transfer to another company. Whether you require the preparation of API for toxicological studies, Phase I–III clinical trials or commercial supplies, we leverage the expertise and technology to make your project a success.
AMRI has the infrastructure to perform rapid scale-up. Our multiple kilo-scale laboratories are equipped for the preparation of cGMP starting materials and other process intermediates on a scale from hundreds of grams to tens of kilograms.
Our capabilities include:
- Multiple jacketed glass reactors from 10 L up to 3000 L capacity
- Large-scale hydrogenation capabilities (up to 80 L GMP and 1000 L non-GMP)
- Synthesis at extremely low or high temperatures with up to 1000 L (-100 °C to 200 °C)
- High-pressure reactions (> 100 psi)
- Large-scale purification equipment (Biotage)
- Dedicated non-GMP and GMP high-potency areas
- Distillation capabilities up to 100 theoretical plates
- Fermentation capabilities