Four Steps To Safer, More Reliable Biomanufacturing

Four Steps To Safer, More Reliable Biomanufacturing

04/02/2019, 1:15 PM - 2:00 PM

Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall
Language:
English
This paper will present the industry collaborations that have formed to address concerns about supply chain management, particulates, extractables, system integrity, manufacturing environment, packaging qualification, and material properties. These initiatives have been developed with the input from Biophorum Operations Group (BPOG), Bio Process Systems Alliance (BPSA), American Society for Testing and Materials (ASTM) and American Society of Mechanical Engineers – Bioprocessing Equipment (ASME-BPE) members. Following these initiatives, this presentation will outline a case study on the qualification package using the BPOG Single-Use User requirements specification process (URS) to aid end-users to risk assess polymeric equipment into their manufacturing processes. It will highlight areas that present current challenges to the supply base and the methods by which the end-user can be assured that the material will not impact the efficacy, purity, and quality of the drug products.

Contributors

  • Sade Mokuolu

    Speaker

    Dr

    WMFTG

    Biography: Dr. Sade Mokuolu is Group Product Compliance Manager at Watson Marlow Fluid Technologies Group (WMFTG). Prior to joining Watson Marlow,...

Type of Session

  1. Type of Session
    Session

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