Scale-Up and GMP Synthesis

Our facility was one of the first of its type to be approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA, equivalent to the US FDA) for the production APIs to current Good Manufacturing Practice (cGMP) standards for both phase I and phase II clinical studies.

• GMP synthesis
• API manufacture and release
• Process validation
• MHRA approved service to European, US and Japanese standards
• Proven record of clinical material production (over 60 individual APIs produced for clinical trials)

Onyx has dedicated GMP kilo laboratories for API production in addition to several flexible isolation rooms for intermediate scale cGMP synthesis work. Our facilities include a class 100,000 clean room and a variety of vessel sizes up to 100 litres. 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 (cGMP) activities when speed of delivery and quality are paramount.

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