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Follow on Google News | Onyx Scientific grows API GMP synthesis contract chemistry servicesExpert in development stage API production, Onyx Scientific manufactures high value intermediates and APIs to GMP-compliant standards for both phase I and phase II clinical studies.
By: Onyx Scientific Ltd Good manufacturing practice (GMP) compliance is an international requirement for the manufacture of medicinal products for human and veterinary use. Compliance ensures medicinal products are produced safely and correctly. Among the first of its type to be approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA, equivalent to the US FDA), Onyx Scientific manufactures high value intermediates and APIs to GMP-compliant standards for both phase I and phase II clinical studies. Commenting on the success behind their GMP growth, Onyx Scientifics’ Following a major round of capital expenditure in 2008, Onyx Scientifics UK based facility boasts dedicated GMP kilo laboratories for API production and flexible isolation rooms for intermediate scale GMP synthesis. The facility includes a class 100,000 clean room and a variety of vessel sizes up to 100 litres, enabling complete technology transfer to manufacturing scale and access to an extensive range of analytical services with expert regulatory guidance provided as standard. The Onyx Scientific service model provides both dedicated FTE and fee-for-service resources, with full transparency and flexibility to switch resource on and off as needed even at short notice. Recognised as the preferred CRO for pharmaceutical outsourcing, Onyx Scientific has developed and made over 60, individual, GMP-compliant APIs for European and US clients. They enjoy the enviable reputation as one of the hardest working chemistry service providers in the industry with best-in-class dedicated project management to harmonize: Communications protocols Selection of the starting materials Mapping of critical manufacturing steps Process parameters and controls for product quality Capacity to reduce or remove impurities Assessment of process robustness Proof that methods are suitable for validation and scale up Identification and control of critical intermediates Certificates of analysis In addition to GMP synthesis and scale up, Onyx Scientifics’ MHRA certified and conforming to international GMP standards, Onyx Scientifics’ # # # In addition to GMP synthesis and scale up, Onyx Scientifics’ Onyx Scientific - with its enviable reputation for multi-step, difficult to produce chemistry - conducts problem solving with unparalleled expertise. The Onyx service model provides both dedicated FTE and fee-for-service resource, with full transparency and flexibility to switch resource on and off as needed and at short notice. End
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