Expert API development and manufacturing services at every stage

Onyx has carved a niche and reputation in the delivery of integrated CMC services for API development and manufacturing built on expert chemistry.

Alongside PR&D and GMP manufacturing we offer dedicated solid state, analytical and regulatory teams, 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. This has made us the preferred CDMO partner to a cross section of academic, biotech and pharma clients across the world.

Our comprehensive CMC services ensure our customers achieve a high quality API to take to market.

PR&D & preclinical batches

Our process 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 development culminating with non GMP manufacture to supply your toxicology & formulation development needs.

Process research & development

Solid form development

Analytical development

Non GMP manufacture

Phase I - III API

Our phase I-III 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 and stability testing.

Analytical

Stability

Process validation

Commercial manufacture

Our commercial manufacturing services mean we can support you and your molecule 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