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2019 Technical Education Program

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  • PDA Roundtable: Data Integrity Across the Enterprise

    04/02/2019, 10:30 AM - 11:15 AM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall
    • Language: English

  • Car-T Facility Design, Startup, and CQV

    04/02/2019, 10:30 AM - 11:15 AM, Javits Conventions Center - INTERPHEX Live Crystal Palace Lobby
    • Language: English

  • BioSpherix Medical: Maximizing Phenotypic and Genotypic Integrity in Therapeutic Cells

    04/02/2019, 10:30 AM - 11:15 AM, Javits Conventions Center - INNOPHEX Stage - Booth 3941

    Cells have been growing in the dish for over 100 years as tools for discovery. Now cells have become promising new therapies. As the most important metric, cell...

    • Language: English

  • Critical Steps for a Successful Drug Product Tech Transfer - Catalent Pharma Solutions

    04/02/2019, 10:30 AM - 11:15 AM, Javits Conventions Center - CMO/CDMO Theatre Booth 1053

    Contract development and manufacturing organizations (CDMOs) occupy a unique position in the pharmaceutical industry. They have the great opportunity of being a...

    • Language: English

  • The Evolution of EBR: Augmented Batch Records

    04/02/2019, 10:30 AM - 11:15 AM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    As EBR evolves, Augmented Bath Records will elevate and empower an organization's human workforce. Organizations can augment existing content, execute on any de...

    • Language: English

  • Real-time Measurement and Controlling of Hydrogen Peroxide Bio-decontamination Cycles

    04/02/2019, 10:30 AM - 11:15 AM, Javits Conventions Center - Stage 3, Booth 1877, Exhibit Hall

    In this presentation, I will outline best practices for using vaporized hydrogen peroxide for bio-decontamination in isolators, restricted access barrier system...

    • Language: English

  • A Transformational Living Cell Environment: A Paradigm Shift in Personalized Medicine that Provided the Most Comprehensive Protection Across all Cell Culture/Processing Operations

    04/02/2019, 10:30 AM - 11:15 AM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    Ongoing research and learnings in In Vitro Fertilization (IVF) programs provide a strong foundation specific to optimizing the in vitro culture environment of t...

    • Language: English

  • Colder Products

    04/02/2019, 11:30 AM - 12:00 PM, Javits Conventions Center - Stage 5, Booth 2477, Exhibit Hall
    • Language: English

  • Lessons Learned: An Industry Post-Serializations

    04/02/2019, 11:30 AM - 12:30 PM, Javits Conventions Center - MG America - Booth 2221
    • Language: English

  • Packaging Line with Aggregation: A Project Management History

    04/02/2019, 11:30 AM - 12:30 PM, Javits Conventions Center - MG America - Booth 2221
    • Language: English

  • Sartorius Stedim

    04/02/2019, 11:30 AM - 12:15 PM, Javits Conventions Center - INNOPHEX Stage - Booth 3941
    • Language: English

  • Leveraging Technologies into the Smart Supply Chain

    04/02/2019, 11:30 AM - 12:15 PM, Javits Conventions Center - INTERPHEX Live Crystal Palace Lobby
    • Language: English

  • 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

  • MilliporeSigma: Using Single-use Technology to Enable Single-pass Tangential Flow Filtration

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

    Single-pass tangential flow filtration (SPTFF) has become a popular method of choice in bioprocessing for purposes of volume reduction, process intensification ...

    • 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

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

  • Continuous Aseptic Manufacturing Using Spray Freeze Drying: Equipment, Process and Product Considerations

    04/02/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    Freeze drying has traditionally been a batch process making it both time consuming and energy intensive. While the use of new process analytical technology has ...

    • Language: English

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