Onyx is now licensed to manufacture commercial API from our UK facility
Here at Onyx, we deliver process research and development services (PR&D) for your small molecule API to meet specific requirements.
Our chemists are trained cGMP compliant and develop your small molecule API to the highest standards, ensuring progress through the development process is as swift as possible. Our early-phase work consists of the production of robust process outlines, stress testing, impurity tracking and specification setting, all aimed at creating the solid foundations required for the future of the project. This is supported by expert analytical development and process chemistry for complete understanding of your compound and GMP manufacture in our custom-built laboratories.
Process R&D aims to provide a safe and scalable route to small molecule API synthesis whilst generating reproducible quality material. At Onyx, we deliver phase-appropriate studies tailored to a project’s needs, with our early-phase work incorporating the production of process outlines, stress testing, impurity tracking (including PGI control) and specification setting. This creates a sound basis for later phase development where we look at more detailed specifications and impurity synthesis that will ultimately lead to process validation. We offer our customers defined work programs with a fixed budget and timeline along with milestone targets and costed assumptions that allow for transparency in scale-up estimations.
Analytical method development ensures that the methods used to measure purity and potency of your small molecule API are of high quality and suitable for a cGMP synthesis. By partnering with Onyx, our customers access a highly experienced team of analytical specialists providing expert advice to ensure all the analytical needs of their projects are met. This includes methods to support raw material release, in process/intermediate testing and final product analysis. Bespoke, highly sensitive methods are also often required for PGI analysis and these are developed and proven during this phase. All of Onyx’s methods are developed with cGMP quality in mind and will be suitable for validation at the appropriate phase.
Solid state chemistry is required to understand and control the physical properties of a drug substance and achieve API synthesis. An in-depth understanding of the API is developed through screening work (including salt screening if applicable) where our high throughput methodology ensures a wide range of counterions and solvents are studied. Solubility is a key parameter throughout this work and detailed solubility testing will help in selecting the correct version of API for onward study. Understanding the range of forms an API can take and their properties is also crucial to deciding on a chosen candidate. Polymorph screening provides this information by producing a detailed form diagram which summarises the findings. Crystallisation development then ensures that the chosen version and form can be generated reproducibly.
Our custom-built non-GMP manufacturing laboratories feature 50 L vessels and 100 L work-up vessels, as well as multi-kilo chromatography capabilities. We typically manufacture 3-5 kg batches with suitability for GLP toxicity studies (CoA, TSE).
We also offer our customers compound support covering impurities, metabolites, stable labelled compounds and building blocks.