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2019 Technical Education Program

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1 - 12 of 14 results

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  • 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

  • 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

  • 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

  • In-Line Monitoring and Real-Time-Release

    04/02/2019, 2:15 PM - 3:00 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    The BioPhorum Technology Roadmap team, consisting of multiple end-user and supplier companies published a Biomanufacturing Technology Roadmap in July 2017. As ...

    • Language: English

  • Aseptic Processing: Achieving Advanced While Staying Flexible

    04/02/2019, 3:15 PM - 4:00 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    While advanced aseptic processing is now well-rooted within the industry, the challenge has shifted from simply achieving the fundamental 'advanced' attributes ...

    • Language: English

  • Risk Management Strategies to Achieve Containment Performance Targets for ADC Applications

    04/02/2019, 4:15 PM - 5:00 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    With the advent of increasingly potent compounds such as ADCs and the greater prevalence of toxic aseptic applications, the understanding of product characteris...

    • Language: English

  • How to Increase Efficiency and Flexibility with Single Use Fermentors

    04/03/2019, 10:00 AM - 10:45 AM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    Current single use microbial fermentors and cell culture bioreactors are not pressurized due to a limitation that the bag is generally unconstrained at the top ...

    • Language: English

  • CFD For Clean Environment: Application Examples

    04/03/2019, 11:00 AM - 11:45 AM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    Medical, pharmaceutical, and other biological research and production facilities benefit from the non-intrusive investigation of air flow available from Computa...

    • Language: English

  • Taking Advantage of Your Manufacturing Data: BioPhorum's Big Data to Smart Data Initiative

    04/03/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    BioPhorum, a consortium of Bio-pharmaceutical manufacturers, equipment suppliers, and technology suppliers, issued a public Automated Facility Road-map in 2017....

    • Language: English

  • Case Study: Un-optimized Procedures and Practices Leading to Recurring Microbial Contamination in Grade A (ISO 5)

    04/03/2019, 2:15 PM - 3:15 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    The case study describes a compliance event with recurrent microbial contamination observed in a grade A filling RABS from January 2017 to June 2017. The microb...

    • Language: English

  • Next-Generation, Integrated Single-use pH, Dissolved Oxygen, and Pressure Instrumentation for Bioprocessing

    04/03/2019, 3:15 PM - 4:00 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    Single-use bioprocessing represents an exciting new development in biopharmaceutical manufacturing. Instrumentation challenges in single-use include installati...

    • 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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