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2019 Technical Education Program

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  • Flexible and Efficient Manufacturing Facilities – A Holistic Approach to the Design and Implementation

    04/02/2019, 11:30 AM - 12:15 PM, Javits Conventions Center - Stage 3, Booth 1877, Exhibit Hall

    Efficient and flexible facilities are designed with an optimal cost of goods, maximum yield, while maintaining flexibility to support changes in the production ...

    • Language: English

  • FDA and EU GMP Annex 1 Differences of Cleanroom Specification. Is it Not Time to Eliminate Them?

    04/02/2019, 11:30 AM - 12:15 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    This presentation highlights several bullet points: - 5.0 μm particles and a general comparison of EU and FDA approaches to cleanroom specification/testing; cri...

    • Language: English

  • 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

    This paper will present the industry collaborations that have formed to address concerns about supply chain management, particulates, extractables, system integ...

    • Language: English

  • Facility Focus: Single Use Biomanufacturing: Designing the Facility of the Future

    04/03/2019, 10:00 AM - 10:45 AM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall

    Last year's Facility Focus survey identified Single Use as the single most useful technology to improve facility flexibility, manufacturing efficiency and utili...

    • Language: English

  • Facility Focus: Priming Projects for Success: Planning and Capital Appropriation for GMP Facilities

    04/03/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall

    Managing capital projects in complex facilities requires both accurate risk assessment and careful planning. Using lessons learned from years of project experi...

    • Language: English

  • Facility Intensification and Cost Reduction Opportunities Using an Integrated Buffer Delivery Platform

    04/03/2019, 2:15 PM - 3:00 PM, Javits Conventions Center - Stage 3, Booth 1877, Exhibit Hall

    Downstream processing of monoclonal antibodies and other proteins requires large volumes of buffer for chromatographic and ultrafiltration operations. Buffer pr...

    • Language: English

  • Flexibility and Predictability: How to Achieve Both in New Facilities

    04/03/2019, 4:15 PM - 5:00 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    Projecting long term capability and capacity needs in drug manufacturing is becoming more difficult as the global landscape changes and new therapies become mor...

    • Language: English

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