The Transition of a Small Molecule API from Development Through to GMP Production

Check out our video to view the transition of a small molecule API from development through to GMP production in our state-of-the-art facilities in Sunderland, UK.

At both of our facilities, we use cutting-edge technology to support our customers with a range of integrated CMC services.

Onyx's Silverbriar Facility

Our state-of-the-art Silverbriar facility is home to...

Process research and development capabilities

Non-GMP small-scale custom synthesis laboratories 


Dedicated solid-state laboratories

Non-GMP analytical method development team

Onyx's Wayfarer Facility

Our Wayfarer site is home to four non-GMP kilo-laboratories (each capable of containing four 50L vessels) including a separate oven room and dedicated areas for rotary evaporation and large-scale column chromatography.

The site also houses our six MHRA-accredited GMP laboratories (ISO 8) for the manufacture of clinical-grade materials (Phase I to III) and commercial drug substances.

The facility is fully equipped to support GMP production, with full testing and release capability in our state-of-the-art GMP analytical laboratory, alongside stability testing facilities.

Our Services

We are a small molecule CDMO specialising in process R&D, non-GMP scale up and GMP manufacture for clinical trials and commercial. Find a summary of our services below...

Process Research & Development

- Process Research & Development

- Analytical Development 

- Non-GMP Manufacture

Phase I-III API Manufacturing

- GMP Manufacturing 

- Analytical 

- Stability

Solid State

- Onyx's Unique Approach 

- Salt screening & Co-crystal Screening

- Polymorph Screening 

- Preformulation Studies 

- Crystallization Screening & Process Development

- Chiral Resolution Screening 

- Crystallography 

- Milling

Commercial API Manufacturing

- Quality by Design/Design of Experiments

- Process Validation

If you want to learn more about the services we offer and how we can help drive your project forward, get in touch with us today by using the form below.

We look forward to understanding your needs and exploring how our services can find the fastest route for your target API.

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