PR&D & preclinical batches

Here at Onyx we deliver process research and development (PR&D) of your API to meet your preclinical batch requirements.

Our chemists develop your API with the highest standards of technical know-how, ensuring progress through the preclinical phase 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 solid state testing for complete understanding of your compound and non GMP manufacture in our custom-built laboratories.

Process research & development

Process research and development (PR&D) aims to provide a safe and scalable route to an API while generating reproducible quality material. At Onyx we deliver phase-appropriate development 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.

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Analytical development

Analytical development ensures that the methods used to measure purity and potency 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.

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Testimonials

  • “We were delighted with the service provided by Onyx Scientific in conjunction with Reach Separations in carrying out full characterisation and identification. The joint effort allowed us to undertake impurity synthesis to get a positive identification of impurity followed by the purification of a sample by prep LC. We found the whole process to be quick, efficient and cost-effective.”

    Sam Hubbard, Analytical Laboratory Manager at Oxford Analytical Ltd
  • “We have found Onyx Scientific to be a cost-effective CMO for API scale-up as well as related analytical and solid state development related to ESN364, Euroscreen’s clinical candidate currently in clinical trials. In fact, we found Onyx Scientific to be cost competitive even when compared against certain Indian CMOs. In addition to this, Onyx Scientific offers the added advantage of proximity in terms of location (and time zone), ease of communication as well as their experience and know-how.”

    Hamid Hoveyda, Director of Chemistry at Euroscreen SA
  • “Onyx Scientific has proven to be technically very capable when it comes to carrying out analytical projects. The team took their time to understand our specific requirements and came up with solutions to overcome any challenges. Communication with the team has been particularly excellent. Importantly for us, the speed of delivery was also exceptional.”

    David Childs, Director CMC at Shield Therapeutics

Solid state development

Solid state development is required to understand and control the physical properties of a drug substance.  An in-depth understanding of the API is developed through salt selection work (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 making the correct choice of salt for onward study.  Understanding the range of forms an API can make and their properties is crucial to deciding on a chosen candidate and a polymorph study looks to provide this information producing a detailed form diagram which summarises the findings.  Crystallisation development then ensures that the chosen salt and form can be generated reproducibly.

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Non GMP manufacture

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.

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