Onyx is now licensed to manufacture commercial API from our UK facility

CMC services for preclinical development & API manufacturing

Onyx has carved a niche and reputation in the delivery of integrated CMC services (chemistry, manufacturing and controls) for preclinical development and small molecule API manufacturing.

Alongside preclinical PR&D and GMP API manufacturing, we offer dedicated solid state chemistry, analytical method development and validation; delivering creative solutions to achieve important milestones for our customers. Our team of highly skilled chemists take a responsive and flexible approach in collaborating with customers to ensure the most effective chemical synthesis of their API.

Our integrated CMC services ensure our customers achieve a high quality API to take to the clinic and to market. This has made us the preferred small molecule CDMO partner to a cross section of academic, biotech and pharmaceutical clients across the world.

Preclinical Research and Development

Our preclinical research and development (PR&D) services deliver excellence in preclinical chemistry. We establish multi-disciplinary teams and focus on phase-appropriate development tailored to a project’s needs. We combine proven expertise in chemistry, solid state and analytical method development, culminating with non GMP manufacture to supply your toxicology and formulation development needs.

Process research & development

Solid form development

Analytical development

Non GMP manufacture

Phase I - III API Manufacturing

Our Phase I-III small molecule API development and manufacturing services support you through each clinical research stage. Led by a team of highly skilled chemists, our approach focuses on seamlessly moving APIs from the lab to the plant, offering a smooth and flexible process from quality assurance and GMP manufacture through to analytical method development and stability testing.

GMP Manufacturing

Analytical

Stability

Commercial API Manufacturing

Our commercial API manufacturing services are available from both our US and UK sites, allowing us to support you and your small molecule API throughout the entire product lifecycle. Our experienced team has Quality by Design (QbD) at its core using statistical optimisation (Design of Experiments (DoE)) to ensure the best understanding of your manufacturing process, establishing the optimum conditions ready for process validation.

QbD/DoE

Process validation

Testimonials

  • “Importantly, when working with Onyx Scientific, our project was delivered on time and within budget. The team at Onyx communicated well and we were pleased with the quality of the final product.”

    Dave Hamre, Pharmaceutical Project Manager at Special Products
  • “Onyx has a tremendous reputation as a premier CDMO, and the results they achieve consistently exceed our highest expectations. If you’re scaling drug substance to take into GMP manufacture, look no further than Onyx.”

    Peter Rands, Managing Director at Small Pharma Ltd
  • “The team at Onyx Scientific definitely provides value for money. They meet deadlines, making them a safe pair of hands and more cost effective in the long run than potentially cheaper competitors.”

    Dr Nigel Westwood, Drug Supply Manager at Cancer Research UK