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  • Commercialization Challenges for Cell and Gene Therapies

    07/15/2020, 10:30 AM - 12:00 PM, Innovation Stage, Booth 1281, Exhibit Hall

    The early promise offered by cell therapies and gene therapies is tempered by the challenges associated with developing, manufacturing, and delivering the drug ...

    • Language: English

  • GMPs and Creating a Quality Culture

    07/15/2020, 1:15 PM - 3:00 PM, Innovation Stage, Booth 1281, Exhibit Hall

    Recent FDA warning letters—often received years after inspectors first noticed the problems in 483s— have identified deficiencies in many pharma company quality...

    • Language: English

  • Standardizing Tech Transfer and Opportunities in Accelerating Drug Development Life Cycle

    07/15/2020, 4:15 PM - 5:00 PM, Innovation Stage, Booth 1281, Exhibit Hall

    A new drug may cost billions of dollars and takes more than ten years to go through different phases in clinical trials and clinical manufacturing to eventually...

    • Language: English

  • Technology Advances in Process Operations: Panel Discussion on How to Use Real-time Monitoring and AI to Optimize Manufacturing Operations

    07/16/2020, 11:15 AM - 12:30 PM, Innovation Stage, Booth 1281, Exhibit Hall

    Today's technology gives manufacturers the ability to collect and analyze large amounts of process data in real-time. How can artificial intelligence and machin...

    • Language: English

  • Genotoxic Impurities and Drug Quality: Lessons from the Nitrosamine Contamination Crisis

    07/16/2020, 1:15 PM - 3:00 PM, Innovation Stage, Booth 1281, Exhibit Hall

    The discovery of genotoxic contaminants in commonly used prescription and OTC medicines over the past two years triggered expensive recalls and raised important...

    • Language: English

  • Stainless Steel to Single-Use: How To Adapt To The Changing Landscape In SUT

    07/16/2020, 3:15 PM - 4:00 PM, Innovation Stage, Booth 1281, Exhibit Hall

    Avid Bioservices recently completed a state-of-the-art single-use manufacturing facility in Tustin, CA. This presentation will focus on scale-up, tech transfe...

    • Language: English

  • Big Data Analytics of Freeze Drying Process and Equipment

    07/17/2020, 10:15 AM - 11:00 AM, Innovation Stage, Booth 1281, Exhibit Hall

    Shifting the state-of-the-art from time based scheduling to data-driven decision making is key when a batch of lyophilized product can sometimes cost in excess ...

    • Language: English