Manchester Lab adds GMP Scale-up Manufacturing Stream
In July 2020, we opened a new Centre of Excellence in Process Chemistry R&D in Alderley Park, Manchester to help accelerate the NCE development programmes of our global innovator customers. This centre has since grown to become a reliable partner to many innovator companies across the world, providing high quality chemistry, non GMP delivery, and successful technology transfer to our sites in India for scale-up. Now, with a growing interest from our customers for clinical API supplies from Manchester, we have set up a GMP Kilo Lab at our Manchester site.
Highlights
- Delivering GMP drug substance and intermediates
- One process stream (2 vessels) of up to 35 L capacity with provision to add more streams
- Supported with associated contained filtration and drying equipment
- Engineered to provide containment to 1μg/m3
- GMP analytical release capability
- Analytical method validation and stability studies to support batch release and regulatory filing
- Compliance by design
- To download the flyer PDF, click here.
- To know more about our services, do get in touch!