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Content Library

HPAPI Summit Content Library

Welcome to the HPAPI Summit Content Library – here you’ll find scientific articles, interviews and past presentations for critical insights to improve your highly potent API development.

  • Presentations Pack

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  • Manufacturing Support for Antibody Drug Conjugates: Clinical and Commercial Scenarios

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  • Tools to address EMA manufacturing guidelines and hazard assessment for development and CMC timelines

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  • How OELs & ADEs Develop Over the Life Cycle of a Drug

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  • Speaker Interview: Dean Calhoun, Affygility Solutions

    Dean Calhoun, CIH is the President and CEO of Affygility Solutions, a consulting company serving the life sciences industry. He is a Certified Industrial Hygienist with over 30 years of experience. He is also an internationally known speaker on the topic of potent compound safety.
    We caught up with Dean to discuss how OELs and ADEs can be effectively incorporated into a broader HPAPI risk management approach.

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  • Speaker Interview: Bob Sussman, Safebridge Consultants

    We recently caught up with Bob Sussman, Managing Principal at Safebridge Consultants, for an exclusive interview.

    Bob shared with us his insights into the main challenges facing the field and some of the emerging therapeutics that will be increasingly important in the highly potent space.

     

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  • Fermion, Cleanroom Technology: CDMO Strategy Key to HPAPI Success

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  • API Cross Contamination in Multi Product Facilities

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  • Lessons Learned From The Early Development Of Linker-Payloads For Antibody-Drug Conjugates

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  • Proactive Integration of Occupational Toxicology Assessments

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  • Current Trends, Challenges & Opportunities In HPAPI Development & Manufacturing

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  • Pfizer’s Strategy for the Development & Manufacture of Linker-Payloads in Antibody-Drug Conjugates

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  • Tools & Techniques for Assessment of Containment & Exposure in The Pharmaceutical Industry

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  • Improving Industry Consistency Presentation sussman

    Improving Industry Consistency: Defining & Maintaining Classification Boundaries

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  • Presentation Merck API Pilot Plant Improving S&IH Compliance through Enhanced Solids Handling

    Merck API Pilot Plant Improving S&IH Compliance through Enhanced Solids Handling

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  • Targeting inflammation by highly potent compounds to treat CNS conditions

    Targeting inflammation by highly potent compounds to treat CNS conditions

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  • Establishing OELs for Potent & Highly Potent Compounds

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  • Presentation Choosing the right CMO for HPAPI manufacturing

    Choosing the right CMO for HPAPI manufacturing

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  • Engineering Controls – Balancing Cost & Containment Hazard

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