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2019 Technical Education Program

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  • Single Use Centrifuge for Large Scale Separation and Collection of CHO and mAbs, and Other Cell Culture Applications

    04/02/2019, 11:30 AM - 12:15 PM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall

    Single use centrifuge advances in cell culture processing techniques have evolved from traditional centrifugation and filtration. The Biopharma Industry requir...

    • Language: English

  • S.T.A.R. (Systematic Transition to Quality and Risk) WARS: May the Interface be With You!

    04/02/2019, 11:30 AM - 12:15 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    During product planning, you must acknowledge the uncertainty associated with the risks in your operating climate. Assessing these risks and how they manifest i...

    • Language: English

  • 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

  • Lessons Learned: An Industry Post-Serializations

    04/02/2019, 12:00 PM - 12:30 PM, Javits Conventions Center - MG America - Booth 2221
    • Language: English

  • MilliporeSigma: Beyond Bioprocessing 4.0:  The Convergence of IT, OT and Processing Technologies Today and Tomorrow

    04/02/2019, 1:00 PM - 1:30 PM, Javits Conventions Center - Stage 5, Booth 2477, Exhibit Hall

    The cost to develop and manufacture monoclonal antibodies has been highlighted as a substantial hurdle towards the widespread availability of these effective th...

    • Language: English

  • CRB Tech Tank: Evolution of the Revolution: The Future of Cell and Gene Therapy

    04/02/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall

    Advanced therapy medicinal product processes have fallen back on manual operations to accommodate the patient-specific scale, but what will these facilities loo...

    • Language: English

  • Pall Biotech: Pharma 4.0 Flexible Facilities – Industry Challenges

    04/02/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - INNOPHEX Stage - Booth 3941

    The concept of flexible facilities isn't new, and the benefits are clear, so why hasn't more progress been made? Understanding the challenges which set the curr...

    • Language: English

  • Piramal Pharma Solutions

    04/02/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - CMO/CDMO Theatre Booth 1053
    • Language: English

  • An Innovative Approach to Cell/Gene Therapy Facility Design

    04/02/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - INTERPHEX Live Crystal Palace Lobby
    • Language: English

  • Scaling with Single-Use Fermentation Creates Challenges to Equipment Design but Brings Economic and Productivity Benefits...Applying 45 Years of Fermenter Engineering Optimization to Design and Scaling of Single-Use Fermenters

    04/02/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - Stage 3, Booth 1877, Exhibit Hall

    The increasing demands of high productivity microbial fermentation for biologic manufacturing has resulted in a progression of improvements in the engineering a...

    • 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

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