Ebook

    Comprehensive Analytical Services:

    Comprehensive Analytical Services:

    07.01.19 - 07.01.20

    Elemental Impurities: Getting from Risk Assessment to Regulatory Submission
    Taking the next steps from risk assessment through method development, method validation and testing to the updating of an annual report or including elemental impurity data in a new regulatory submission.
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    Risk Assessment and Testing Requirements for Elemental Impurities in Pharmaceutical Products
    Understanding and developing strategies for risk assessment and analytical testing to ensure compliance with the requirements of ICH Q3D, Guideline for Elemental Impurities, USP <232>, “Elemental Impurities, Limits,” and USP <233>, “Elemental Impurities, Procedures.”
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    Elemental Impurity Testing
    Advances in elemental impurity testing aid compliance with new USP requirements
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    ELEMENTAL IMPURITIES: A VIRTUAL COMPANY PERSPECTIVE
    A look at risk assessments for elemental impurity determinations in oral tablet and parenteral drug products. Read More >>
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    Biopharmaceuticals & Analytical Testing Technology

    Biopharmaceuticals & Analytical Testing Technology

    06.01.19 - 06.01.20

    Current Trends in Analytical Testing
    Improved analytical methods continues to be a current need for nearly every aspect of biopharma manufacturing
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    Are We Embracing FDA’s Messages?
    FDA guidance on analytical procedures and methods validation for drugs and biologics.
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    Next-Gen Bioprocessing
    Overcoming the challenges of characterizing bioprocess residual impurities in biologics using HPLC/MS
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    Process Validation in Biologics Development
    Strategies for successful process validation in the wake of faster approval timelines Read More >>
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    Trends in Biologics Manufacturing from Drug Substance to Fill/Finish

    Trends in Biologics Manufacturing from Drug Substance to Fill/Finish

    November 1 - 30, 2019

    Biopharmaceutical companies and contract manufacturing organizations are investing to increase biomanufacturing and drug product fill-finish capacity in order to keep up with the pace. Fast track approvals, increased focus on orphan diseases and the emergence of personalized medicine are influencing how the industry makes its investment decisions. This ebook examines current and future trends in biologics development and manufacturing and the steps companies are taking to address this changing landscape.

    Biopharma Manufacturing Markets
    Biomanufacturing contract services and supplies markets continue to expand.
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    CEO Spotlight — Catalent
    A conversation with John Chiminski, CEO of Catalent Pharma Solutions.
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    Biopharmaceutical Contract Manufacturing Trends
    Examining the importance of fill-and-finish operations in today's biopharma manufacturing market.
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    Next-Gen Biologics Packaging & Delivery
    As the frontier of drug innovation evolves, so must the design of packaging and delivery systems. Read More >>
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