Onyx Scientific - Lead Optimisation, Process Development and Scale-Up Synthesis

Onyx Scientific provides a wide range of chemical services to the life sciences industry. We specialise in medicinal chemistry, pre-clinical development and GMP scale-up, in addition to offering a comprehensive range of analytical services.

Onyx Scientific is one of the fastest growing pharmaceutical service companies in the UK.

LEAD OPTIMISATION

Our bespoke service encompasses a customer-driven approach to the synthesis of key target compounds. Our expertise lies with route design and parallel synthesis of small focused library sets of, typically, five to 50 compounds.

Furthermore, our knowledge and interpretation of SAR data, together with in-house synthetic experience, allow us to quickly and cost-effectively select, optimise and progress leads to the next stage of development.

Typical services include:

• Route scouting/design followed by first known synthesis
• Analogues of lead and second generation compounds
• Focused library sets (5 - 50 compounds, 5mg - 250mg, >95% purity)
• Rapid scale-up of high priority compounds

CUSTOM SYNTHESIS AND PROCESS DEVELOPMENT

Process research and development is Onyx Scientific's core strength and we have a proven record of taking compounds from early development through clinical studies.

Our process development group is lead by scientists with many years’ experience of API development, scale-up and production. We evaluate the most critical areas during scale-up in order to produce robust, scalable and, most importantly, reproducible processes, capable of synthesizing material in a cost-effective manner.

Typical services include:

• Route selection and development
• Rapid scale up of lead compounds
• Full custom synthesis
• Process optimisation and research support right through to production

We specialise in complex multi-stage synthesis and supply mg to kg quantities of key intermediates, including scaffolds, building blocks, metabolites, analogues and APIs.

SCALE-UP AND GMP SYNTHESIS

Our facility was one of the first of its type to be approved by the MHRA for the production of APIs to GMP standards for both phase I and phase II clinical studies.

• API manufacture and release
• Process validation
• MHRA-approved service to European and US standards
• Proven record of clinical material production

Onyx has dedicated GMP kilo laboratories for API production, as well as several flexible isolation rooms for intermediate scale GMP work. Our facilities include class 100,000 clean rooms and a variety of vessel sizes up to 50L. We also offer complete technology transfer to manufacturing scale. An extensive range of analytical support, expert regulatory guidance and advice is provided as standard.

Onyx is the ideal partner for your GMP activities when speed of delivery and quality are paramount.

ANALYTICAL SERVICES

In addition to supporting our synthetic chemistry groups, Onyx provides an independent and comprehensive range of analytical chemistry services. Our specialist team of experienced analytical scientists operate within fully equipped and validated analytical laboratories.

Typical services include:

• Complete analytical support, including NMR, MS, LC and GC
• Method development and validation
• Impurity identification, profiling and isolation
• API stability studies
• Independent contract analysis

If you are looking for an analytical partner or bespoke support, we have the equipment and expertise to meet your needs.

EQUIPPED TO TACKLE MOST SYNTHETIC PROJECTS

Staffed by qualified and experienced chemists, Onyx Scientific is well equipped to tackle most synthetic projects.

We have successfully completed thousands of separate synthesis projects involving a whole range of synthetic reactions and transformations. Projects at Onyx can vary from small-scale lead optimisation studies to multi-kilo, multi-step GMP projects.