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

Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process qualification through a validation campaign is the method by which a process is shown to be under control and capable of reproducible commercial manufacturing.

A validation master plan is written at the start of the validation project and defines the scope and goals of the overall validation project. A pre-approved validation protocol is written per stage which details the pre-requisites required ahead of validation batches (e.g. Equipment DQ, IQ, OQ, analytical method validations) and the criteria that must be met for successful validation campaign. The results of the development and DoE work allow critical process parameters and their normal operating ranges / proven acceptable ranges to be defined with confidence.

The analytical targets identified during the development, DoE work and purge studies are also included as these will be used demonstrate that a process is under control. At least 3 consecutive validation batches are nominated, although a 5-batch campaign is recommended to allow for commissioning, especially if the material has not been synthesised at this scale previously. A validation campaign is then carried out and completed successfully if the nominated batches achieve the pre-defined criteria. The key to success at this point is to ensure a thorough understanding of the process has been achieved in the earlier work. Once validation is complete continued process verification is performed with trend analysis used to identify problems early before and ensure the process stays under control.

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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