Almac Solid State Chemistry Feb 10 Linked In


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An overview of Solid State Chemistry Services at Almac

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  • Almac Solid State Chemistry Feb 10 Linked In

    1. 1. Solid State Services at ALMAC Supporting the development of APIs from invention to launch February 2010
    2. 2. Overview <ul><li>Almac has extensive experience of API and drug product development. Our comprehensive range of solid state services and know-how will help strengthen the success of your product. </li></ul><ul><li>Expertise in: </li></ul><ul><ul><ul><li>Polymorph screening & selection </li></ul></ul></ul><ul><ul><ul><li>Salt & Cocrystal selection </li></ul></ul></ul><ul><ul><ul><li>Amorphous materials </li></ul></ul></ul><ul><ul><ul><li>Pharmaceutical materials science </li></ul></ul></ul><ul><ul><ul><li>Formulation development </li></ul></ul></ul>
    3. 3. Solid State Services <ul><li>Polymorph Screening </li></ul><ul><ul><li>Indication of polymorphism </li></ul></ul><ul><ul><li>Polymorph selection </li></ul></ul><ul><ul><li>Stable form determination </li></ul></ul><ul><li>Physical Form Selection </li></ul><ul><ul><li>Optimum form for development </li></ul></ul><ul><ul><li>Reproducible drug substance </li></ul></ul><ul><li>Crystal Engineering </li></ul><ul><ul><li>Salt and Cocrystal screening </li></ul></ul><ul><ul><li>Crystal modification </li></ul></ul><ul><li>Troubleshooting </li></ul><ul><ul><li>Batch to batch variation? </li></ul></ul><ul><ul><li>Problems meeting specs? </li></ul></ul><ul><li>Characterisation </li></ul><ul><ul><li>Drug product </li></ul></ul><ul><ul><li>Drug substance </li></ul></ul><ul><li>Crystallisation Development </li></ul><ul><ul><li>Process development, scale-up </li></ul></ul><ul><li>Routine Analyses </li></ul><ul><ul><li>DSC, TGA, XPRD </li></ul></ul><ul><ul><li>Lot release </li></ul></ul><ul><ul><li>GMP compliant </li></ul></ul><ul><li>Method validation </li></ul><ul><li>Legal support </li></ul><ul><ul><li>Regulatory and IP </li></ul></ul><ul><ul><li>Litigation </li></ul></ul><ul><li>Pre-formulation & Formulation Development Services </li></ul>
    4. 4. What makes us different? <ul><li>Screens tailored to customer requirements </li></ul><ul><ul><li>Mini screens requiring as little as 200mg of material </li></ul></ul><ul><ul><li>Conventional and novel crystallisation techniques </li></ul></ul><ul><li>Screens driven by science not robotics </li></ul><ul><ul><li>Highly trained chemists and analysts </li></ul></ul><ul><ul><li>Directed investigation: not just following protocols </li></ul></ul><ul><li>Integrating drug substance and drug product </li></ul><ul><ul><li>Crystallisation development and scale up under GMP </li></ul></ul><ul><ul><li>Uniting process, operations and formulation </li></ul></ul>
    5. 5. Crystal Form <ul><li>It is somewhat ironic, that after years of high-tech complex research including target validation, cell biology, pharmacology, medicinal chemistry and computational modelling, a simplistic thing like a new crystal form with a slightly higher melting point can de-rail (or almost de-rail) a program. 1 </li></ul><ul><li>…structure prediction, which would be most valuable for process chemistry, still has some way to go… 2 </li></ul>1. Polymorphs and Salts 2. Editorial, OPRD 15 Jan 2010
    6. 6. Effect of Polymorphism on Solubility Solubility of the fluoroquinolone (US Patent 5,985,893)
    7. 7. We consider the Whole Process Preferred Form Desired properties <ul><li>Solid liquid separation </li></ul><ul><li>Issues: </li></ul><ul><ul><li>Purity </li></ul></ul><ul><ul><li>Yield </li></ul></ul><ul><ul><li>Particle size </li></ul></ul><ul><ul><li>Polymorph </li></ul></ul><ul><li>Drying </li></ul><ul><li>Issues: </li></ul><ul><ul><li>Solvent removal </li></ul></ul><ul><ul><li>Polymorph </li></ul></ul><ul><ul><li>Particle size </li></ul></ul><ul><ul><li>Agglomeration </li></ul></ul><ul><ul><li>Lumping </li></ul></ul><ul><ul><li>Breakage </li></ul></ul>Micronise Issues: Form change De-lumping Particle size reduction Provides consistency <ul><li>Crystallisation </li></ul><ul><li>Issues: </li></ul><ul><ul><li>Supersaturation </li></ul></ul><ul><ul><li>Nucleation </li></ul></ul><ul><ul><li>Polymorph </li></ul></ul><ul><ul><li>Purity </li></ul></ul><ul><ul><li>Yield </li></ul></ul><ul><ul><li>Particle size </li></ul></ul><ul><ul><li>Habit </li></ul></ul>Final Product Preferred Form Desired properties
    8. 8. Pre-formulation & Formulation Development Services <ul><li>Formulation feasibility studies </li></ul><ul><li>Preclinical formulation development for Pharmacology and toxicology </li></ul><ul><li>Formulation, process scale up and technology transfer </li></ul><ul><li>Formulation consultancy </li></ul><ul><li>IP services - We support patent applications / EPO oppositions </li></ul>
    9. 9. Legal support (technical) <ul><li>Expertise built from a large volume of diverse projects puts Almac in a unique position to provide expert witnessing services to pharma litigation cases, as a testifying or non-testifying witness. We provide services to both infringement and Paragraph IV cases. </li></ul><ul><li>We provide technical expertise to assist in successful patent prosecution. This service includes technical consultancy for IP and technical support for successful prosecution to overcome rejections and oppositions. </li></ul><ul><li>In addition, Almac provides counterfeit analysis to pharma industry using our state of the art technology. </li></ul>
    10. 10. Conclusion Almac can support every stage of the drug development process. We have solid state services to support differing research needs and budgets. Almac provides an integrated approach to drug substance and drug product.