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    Pharma Services Category of Onyx Scientific

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 Analytical Method Development (1)

    02 Contract Manufacturing (2)

    03 GMP Manufacturing (1)

    04 Preformulation & Material Science (1)

    05 Process Development & Optimization (1)

    06 Stability Studies (1)

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    01 Onyx Scientific (7)

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    01 United Kingdom (7)

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    Onyx Scientific

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      PROCESS RESEARCH & DEVELOPMENT

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      Onyx Scientific delivers process research & development services (process R&D) for your small molecule API to meet specific requirements. Its early-phase work consists of the production of robust process outlines, stress testing, impurity tracking, etc.

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      Pharma Service: API Manufacturing

      Category: Process Development & Optimization

      Sub Category: Overview
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        NON-GMP MANUFACTURING

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        Onyx Scientific's custom-built non-GMP manufacturing laboratories feature 50 L vessels & 100 L work-up vessels, as well as multi-kilo chromatography capabilities. It manufactures 3-5 kg batches with suitability for GLP toxicity studies (CoA, TSE).

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        Pharma Service: API Manufacturing

        Category: Contract Manufacturing

        Sub Category: Overview
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          PHASE I-III GMP MANUFACTURING

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          Onyx Scientific's Phase I-III small molecule API development and manufacturing services support through each preclinical research stage. It offers GMP manufacturing along with analytical method development and stability testing.

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          Pharma Service: API Manufacturing

          Category: GMP Manufacturing

          Sub Category: Overview
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            SOLID STATE DEVELOPMENT

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            Onyx Scientific uses solid state chemistry to mitigate risk throughout the development process by gaining an in-depth understanding of the physicochemical properties of your active pharmaceutical ingredients (APIs).

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            Pharma Service: API & Drug Product Development

            Category: Preformulation & Material Science

            Sub Category: Solid State Characterization
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              ANALYTICAL DEVELOPMENT

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              Onyx Scientific has a highly experienced team of analytical specialists to ensure all the analytical needs of their projects are met. All of Onyx’s methods are developed with cGMP quality & will be suitable for validation at the appropriate phase.

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              Pharma Service: Analytical

              Category: Analytical Method Development

              Sub Category: Method Development and Validation
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                ANALYTICAL & STABILITY TESTING

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                Onyx's analytical method development ensures that the methods used to measure purity & potency of small molecule API are of high quality. Its early-phase work consists of the production of robust process outlines, stress testing, impurity tracking, etc.

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                Pharma Service: Analytical

                Category: Stability Studies

                Sub Category: Overview
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                  COMMERCIAL API MANUFACTURING

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                  Onyx Scientific's commercial API manufacturing services are available from both its US & UK sites, to support your small molecule API throughout the entire product lifecycle.

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                  Pharma Service: API Manufacturing

                  Category: Contract Manufacturing

                  Sub Category: Overview
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