2019 Technical Education Program

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  • BioSpherix Medical

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

  • Catalent Pharma

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

  • Trillium

    04/02/2019, 11:30 AM - 12:15 PM, CMO/CDMO Theatre Booth 1053
    • Language: English

  • Biosimilars 5.0

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

  • Single Use Centrifuge U2k for Large Scale Separation and Collection of High Density Mammalian Cells and Mabs.

    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. The Biopharm Industry required improvement...

    • 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

  • Integrity Bio Inc.

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

  • Piramal Pharma

    04/02/2019, 1:15 PM - 2:00 PM, 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

  • Esco Technologies

    04/02/2019, 2:15 PM - 3:00 PM, Javits Conventions Center - INNOPHEX Stage - Booth 3941
    • Language: English

  • Confab Laboratories

    04/02/2019, 2:15 PM - 3:00 PM, CMO/CDMO Theatre Booth 1053
    • Language: English

  • Collaboration and Proven Results: Where Do We Go from Here? SUPAC? QbD?

    04/02/2019, 2:15 PM - 3:00 PM, Javits Conventions Center - INTERPHEX Live Crystal Palace Lobby
    • Language: English

  • Single-Use System Supports a Freeze/Thaw Platform Capable of Providing an End-to-End Solution for Fluid Drug Substance Inter-Facility Storage and Delivery

    04/02/2019, 2:15 PM - 3:00 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    The inter-facility management of freeze/thaw processes of drug substances has been a challenge fraught with issues that affect sites around the globe. Drug manu...

    • Language: English

  • Single-Use Filling Systems Maximize Filling Line Flexibility and Efficiency

    04/02/2019, 2:15 PM - 3:00 PM, Javits Conventions Center - Stage 3, Booth 1877, Exhibit Hall

    Usage of single-use technologies in both clinical and commercial applications is rapidly growing. A comparison between traditional reusable final fill componen...

    • 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

  • TerumoBCT

    04/02/2019, 3:15 PM - 4:00 PM, Javits Conventions Center - INNOPHEX Stage - Booth 3941
    • Language: English

  • CMIC CMO USA

    04/02/2019, 3:15 PM - 4:00 PM, CMO/CDMO Theatre Booth 1053
    • Language: English

  • Pharma Intelligence: 2019 State of Investment

    04/02/2019, 3:15 PM - 4:00 PM, Javits Conventions Center - INTERPHEX Live Crystal Palace Lobby
    • Language: English

  • Regulations for Submitting Tableting & Encapsulating Machine Transactions Online

    04/02/2019, 3:15 PM - 4:00 PM, Javits Conventions Center - Stage 3, Booth 1877, Exhibit Hall

    Do not let your imported tableting and encapsulating machines be detained by U.S, Customs. Your purchasing agent or broker may not be aware of the need to info...

    • Language: English

  • PAT-based Linear pH Gradient as an Alternative Platform to Downstream Process Monoclonal Antibodies

    04/02/2019, 3:15 PM - 4:00 PM, Javits Conventions Center - Innovation Stage - Booth 1281

    Use of Protein A along with salt gradient platform to capture monoclonal antibodies (mAbs) has been the practice for the past twenty-five years. However, Protei...

    • Language: English

  • Innovative RAPA : "Risk Analysis & Preventive Actions" Approach. Case Study of OSD High Potent (OEL1 to OEL5) Facilities Design Meeting cGMP & HSE requirements.

    04/02/2019, 3:15 PM - 4:00 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    Risks management represent an essential step in the process validation implementation during all the life cycle of a given pharmaceutical plant from its concept...

    • 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

  • INNOPHEX Reception Sponsored by GERMFREE

    04/02/2019, 4:00 PM - 5:00 PM, Javits Conventions Center - INNOPHEX Stage - Booth 3941
    • Language: English

  • Therapure Biopharma

    04/02/2019, 4:15 PM - 5:00 PM, CMO/CDMO Theatre Booth 1053
    • Language: English

  • Oral Administration and Therapy

    04/02/2019, 4:15 PM - 5:00 PM, Javits Conventions Center - INTERPHEX Live Crystal Palace Lobby
    • Language: English

  • Innovative GAPA: "Gap Analysis & Preventive Actions" Design Approach. Case Study – cGMP Sterile Facilities Design New Trends Involving Continuous Process Validation Guidelines (FDA2011).

    04/02/2019, 4:15 PM - 5:00 PM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall

    About 45% of drug and device recalls are due to design issues. These defects represent the main source of risks that, if furthermore neglected, can trigger sign...

    • Language: English

  • Smart Evolution: Planning Your First Laboratory or Manufacturing Facility

    04/02/2019, 4:15 PM - 5:00 PM, Javits Conventions Center - Innovation Stage - Booth 1281

    This interactive panel discussion will focus on three distinct phases in the evolution of a start-up – growth planning for validation and small-batch manufactur...

    • 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

  • Exploring a Blockchain Enabled Supply Chain

    04/02/2019, 4:15 PM - 5:00 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    Despite the billions being invested in protecting products and securing the supply chain, we are not seeing a material decrease in issues. The gray market is s...

    • Language: English

  • A Risk Based Approach for Cleaning and Disinfection Program

    04/02/2019, 4:15 PM - 5:15 PM, Javits Conventions Center - Stage 3, Booth 1877, Exhibit Hall

    The presentation presents and analyzes the different regulatory requirements related to cleaning and disinfection program. The presentation discusses the differ...

    • Language: English

  • Teligent Inc

    04/03/2019, 10:00 AM - 10:45 AM, CMO/CDMO Theatre Booth 1053
    • Language: English

  • Advanced & Highly Adaptive Automation Technology Integrated with Industry 4.0 Trends

    04/03/2019, 10:00 AM - 10:45 AM, Javits Conventions Center - INTERPHEX Live Crystal Palace Lobby
    • Language: English

  • Walking Through a Practical Energy Conservation Program (ISO50001) Using an IoT Technology for Compressed Air Usage at a Large Pharma Facility

    04/03/2019, 10:00 AM - 10:45 AM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    ISO50001 is a guideline for manufacturers to reduce energy consumption. Pharma end users adopt this program to improve environmental impact & reduce utility co...

    • Language: English

  • Requirements of 2019 Edition of NFPA 652 Standard on Combustible Dust - On Your Way Towards Compliance?

    04/03/2019, 10:00 AM - 10:45 AM, Javits Conventions Center - Stage 3, Booth 1877, Exhibit Hall

    Dr. Ebadat will overview NFPA 652: National Fire Protection Association's (NFPA) 652: Standard on Fundamentals of Combustible Dusts, which addresses the genera...

    • 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

  • NanoCool

    04/03/2019, 11:00 AM - 11:45 AM, Javits Conventions Center - INNOPHEX Stage - Booth 3941
    • Language: English

  • LSNE Contract Manufacturing

    04/03/2019, 11:00 AM - 11:45 AM, CMO/CDMO Theatre Booth 1053
    • Language: English

  • Adding Intelligence to Legacy Assets Through Artificial Intelligence and Domain Expertise for Operational Excellence

    04/03/2019, 11:00 AM - 11:45 AM, Javits Conventions Center - INTERPHEX Live Crystal Palace Lobby
    • Language: English

  • How Are You Driving Speed to Market?

    04/03/2019, 11:00 AM - 11:45 AM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall

    Changing market dynamics are driving the need for more flexible, high quality manufacturing systems.  Increased competition, challenges associated with personal...

    • Language: English

  • Adding Intelligence to Legacy Assets Through Artificial Intelligence and Domain Expertise for Operational Excellence

    04/03/2019, 11:00 AM - 12:15 PM, Javits Conventions Center - INTERPHEX Live Crystal Palace Lobby

    An article published in Pharmaceutical Manufacturing studied 50 pharmaceutical manufacturing lines worldwide and found that a staggering 26% of capacity loss is...

    • Language: English

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