Process Development Expertise Positions Onyx Scientific As The Preferred Chemistry Services Provider For Contract GMP API Development

Top Quote Onyx Scientifics' contract chemistry services include: custom synthesis, process development, lead optimization, GMP synthesis and scale up, automated salt selection, crystallization studies, polymorph screening and solid-state analysis. End Quote
  • (1888PressRelease) May 26, 2010 - Onyx Scientific Ltd, the premier provider of outsourcing chemistry services, credits its problem-solving Process Development expertise and custom organic synthesis capability for its growing reputation as the preferred chemistry services provider within the custom synthesis market.

    A research-driven and customer-focused company, Onyx Scientific provide pharmaceutical and biotechnology companies a broad and integrated portfolio of contract chemistry services throughout the drug discovery and development process, services that include: Process Development, Custom Synthesis, GMP synthesis and Scale-up, Analytical and Solid-State services, automated Salt Selection and Polymorphism screening studies.

    Good Manufacturing Practice (GMP) and the development of reproducible Active Pharmaceutical Ingredients (APIs) require a clear understanding of chemical route selection, the development of a scalable GMP process and the generation and protection of intellectual property.

    CEO, Tony Flinn comments, "whether developing a new process or improving an existing synthetic route, Onyx Scientific will aim to develop a process that is entirely practical with reduced synthetic steps and costs. In parallel, we conduct multi-step analysis to validate a process as scalable, reproducible and above all safe. We will try to eliminate toxic reagents, avoid chromatography and minimise waste. Solvents are chosen with regard to their residual effects and for new APIs we ensure ICH guidelines are followed. Where possible, we ensure that sustainable processes are developed using 'green chemistry' and we will work to convert stoichiometric processes to catalytic processes".

    Expert in medicinal chemistry, with multi-kilo GMP scale-up capability, Onyx Scientifics' Process Development services include:
    Chemical route selection and economic modelling
    Selection of starting materials
    Method development and impurity identification
    Process optimization and Scale-up
    Assessment of process robustness
    Process validation and documentation
    Technology transfer

    Responsive to patent expirations and lean pipeline challenges, Onyx Scientific provide 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.

    MHRA certified, Onyx Scientifics' state-of-the-art facility conforms to international GMP standards for the development of active pharmaceutical ingredients.

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