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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

  • Settling the Frontier of Fill-Finish Operations – High Tech Filling in a Proper Abode

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Fill/finish operations represent perhaps the last frontier of significant risk in manufacturing injectable medicines. Closed systems in compounding and formulat...

    • 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

  • Integrating IoT into your Life Sciences Packaging and Supply Chain Strategy - Best Practices to Take this Valuable Leap

    04/17/2018, 4:15 PM - 5:00 PM, INTERPHEX Innovation Stage

    In today's world, technology is advancing every second. The Internet of Things phenomenon has enabled groundbreaking advances in connected devices and personali...

    • Language: English

  • Ensuring reliable, consistent production in pharmaceutical water systems

    04/18/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    Design and quality of water system equipment play a big role in optimizing pharmaceutical manufacturing - a huge, profitable and easily accessible potential. W...

    • Language: English

  • Global pharmaceutical packaging trends, beyond Serialization

    04/18/2018, 1:15 PM - 2:00 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    The session will consist of a thorough walk-trough of world map updated regulatory requirements as well as supply chain stakeholder's demands and needs. Deep di...

    • Language: English

  • Current trends & considerations for drug delivery device assembly of self-administered products

    04/18/2018, 3:15 PM - 4:00 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    A) Post device selection POP (proof of principle) and process development considerations Once the delivery device(s) has been determined for the final deliver...

    • Language: English

  • Lessons learned from microbial contamination in pharmaceutical manufacturing –Benefit of end user and supplier collaboration

    04/18/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    The audit remarks related to inadequate microbial contamination control and the investigation of discrepancies from 2014 and 2015 by the FDA auditors are increa...

    • Language: English

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