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2018 Technical Education Program

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  • Integrating a Programmable Robotic Bioreactor System with a Biochemical Analyzer for Real-time Analysis

    04/17/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    High-throughput bioreactor robotic systems have started to replace traditional, labor and time intensive methods of using shake flasks and stirred tank reactors...

    • Language: English

  • Data Integrity and Management in the Pharmaceutical Industry. Understanding and Complying with GMP & FDA requirements.

    04/17/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    ♦Today, both the MHRA and FDA are highly focused on data integrity and currently discourage methods by which data is recorded manually. Modern data management s...

    • Language: English

  • Start-ups – Moving out of the Incubator into a New Pilot/Manufacturing Facility

    04/17/2018, 1:30 PM - 2:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    Start-up companies often have their beginnings in a crowded flex space. After years of research and testing, they finally developed a viable product. This is ...

    • Language: English

  • Optimized Manufacturing of mAb-based Products: Flexibility, Speed, and Efficiency can Co-exist

    04/17/2018, 2:30 PM - 3:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    The manufacture of mAb-based products represents a large portion of many company's drug substance pipeline. In order to ensure that critical business goals focu...

    • Language: English

  • Case Study: Capacity Expansion and Conversion to Single-Use BioProcessing at an Existing cGMP CDMO Facility

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    With growing demand in the biologics CDMO market, Merck KGaA (Darmstadt, Germany) elected to expand capacity at its existing cGMP biomanufacturing facility in M...

    • Language: English

  • Process Economics: The Driving Force behind the Criteria for Cell Therapies Facility Design

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    Today's small number of approved cellular therapy products (13 FDA-approved), a large number of clinical trials (>10,000), and favorable regulatory climate, as ...

    • Language: English

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