Small scale commercial API specialists

Onyx delivers integrated services that take projects from API development through to ongoing supply.  Our manufacturing scales range from low kilo quantities, making us ideally suited to meet the needs of a low volume drug substance (e.g. for orphan diseases), right up to the multi-tonne quantities required for high volume commercial supply.

Onyx Scientific (Sunderland) specialises in small-scale API manufacturing catering for low volume APIs and offers a flexible approach that is suited to today’s complex materials. Onyx Scientific (North Carolina) has pilot and full-scale production facilities available and is ready to manufacture the larger quantities needed for many projects.

When scaling up a project, we offer dedicated scientists and rapid tech transfer between sites supporting our GMP manufacturing teams. Both sites have a proven track record of successfully validating processes at the required production scale and are fully supported by Onyx’s quality assurance (QA) team that maintains the highest level of quality standards.

QbD / DoE

Quality by design (QbD) brings a systematic approach to pharmaceutical development. Statistical optimisation through Design of Experiments (DoE) is the main tool used to both optimise and understand the manufacturing process.

This data-driven method delivers better understanding of the manufacturing process, reducing the occurrence of batch failures, delivering proven and effective control, as well as bringing greater time and cost efficiencies. By taking this approach we provide a robust process that will achieve a consistent and high level of quality suitable for process validation.

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Process validation

Prior to GMP manufacture, the process outlines produced in development are converted into step-by-step instructions in a Process Record Sheet (PRS). Our team of highly trained GMP chemists follow these detailed instructions when making customer material, with our development team also being on hand to advise for those difficult stages. Any deviations are documented in line with our quality procedures through non-conformance reports (NCRs) and out of specification (OOS) reports. Corrective action and preventative action plans (CAPA) can then be put in place when required and are documented through our change control (CC) procedure.

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Testimonials

  • “I have no hesitation in recommending working with Onyx Scientific. Flexible and knowledgeable, Onyx has the capabilities needed to complete API chemical development and kilogram-scale GMP manufacturing projects to very high standards and in a cost-effective manner. What’s more, the team is made up of high-quality scientists and the direct interaction approach to project management that they take makes it feel as though I have my very own chemistry team there.”

    Peter Spargo, Senior Vice President Chemistry Manufacturing at Verona Pharma
  • “As we have moved towards advancing our clinical trial schedule, we have been very pleased with the continued commitment, expertise and support that Onyx Scientific has provided. The team’s flexibility and attention to detail throughout the process, including the adherence to stringent cleaning validation procedures, has assisted us in keeping our project on-track.”

    Michael Roe, Chemistry & CMC Technical Manager at KalVista Pharmaceuticals
  • “Onyx Scientific has a niche in the market. As a contract manufacturing organisation that doesn’t have to bear the high costs of running a pilot plant, it can deliver high quality materials for IND-enabling toxicology studies and early phase development in a cost-effective manner. We would definitely recommend Onyx for anyone considering their options for scale-up and GMP synthesis.”

    Matthew Fyfe, Head of Chemistry at Topivert