Occupying over 3000m² in North East England (30m from Newcastle International Airport), our MHRA-approved R&D laboratories have been designed to meet the needs of our clients and provide an excellent working environment for our chemists. Our site includes a fully equipped medicinal chemistry facility for lead optimisation and custom synthesis work, enviously equipped process development laboratories and specialist kilo laboratories for GMP synthesis.
Our UK labs also include a full range of analytical support at the standard you would expect from a leading supplier to the industry.
We also have a dedicated laboratory, housing 4 stability chambers at varying temperature and relative humidity settings for stability testing. Conditions are monitored using fully validated 21 CFR Part 11 compliant wireless probes. In addition, photostability can be monitored.
Solid state facility
Out dedicated solid state lab allows for characterisation of NCEs including polymorph investigation and solubility profiling such as salt screening and selection.
We have access to seven API sites in India for tech transfer, pilot-scale work, Phase II – commercial and large scale manufacturing.
Our team of dedicated scientists and engineers at our R&D centre work closely with our UK team to enable rapid internal tech transfer from our UK-based site if required.
Scale-up and process development
Our flagship site in India is based in Ratlam. It has co-located development labs, fully equipped analytical facilities, GMP Kilo labs/ Pilot plants, 25-65L glass lined vessels with cryogenic capabilities and over 22 API manufacturing plants. In addition, we have three advanced intermediates and two API manufacturing locations in India.
Pilot plants and large-scale manufacturing
With over 750 personnel at site, our MHRA & FDA approved facilities have an excellent quality audit record and are well positioned to help progress your late stage clinical candidates as well as provide sustainability to your late life cycle products. Our capabilities include:
• Pilot scale (100-1000 Liters) with batch sizes from 10-50 Kilograms
• 2 Multiple reactor pilot streams 17-34 reactors
• Autoclave, molecular sieves, agitated thin film dryers etc
• Cryogenic capability (-70 deg C) at 300L reactor capability
• Powder processing area (Class 100,000)
• >320 Reactors 100-11000 Liters
• 4 Autoclave Reactors (7-3000 Liters)
• Batch sizes up to 1000 Kilograms
Contact us today to discuss your project needs in more detail.