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2019 Technical Education Program

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  • PDA Roundtable: Data Integrity Across the Enterprise

    04/02/2019, 10:30 AM - 11:15 AM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall
    • Language: English

  • Car-T Facility Design, Startup, and CQV

    04/02/2019, 10:30 AM - 11:15 AM, Javits Conventions Center - INTERPHEX Live Crystal Palace Lobby
    • Language: English

  • BioSpherix Medical: Maximizing Phenotypic and Genotypic Integrity in Therapeutic Cells

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

    Cells have been growing in the dish for over 100 years as tools for discovery. Now cells have become promising new therapies. As the most important metric, cell...

    • Language: English

  • Critical Steps for a Successful Drug Product Tech Transfer - Catalent Pharma Solutions

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

    Contract development and manufacturing organizations (CDMOs) occupy a unique position in the pharmaceutical industry. They have the great opportunity of being a...

    • 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

  • Colder Products

    04/02/2019, 11:30 AM - 12:00 PM, Javits Conventions Center - Stage 5, Booth 2477, Exhibit Hall
    • Language: English

  • Lessons Learned: An Industry Post-Serializations

    04/02/2019, 11:30 AM - 12:30 PM, Javits Conventions Center - MG America - Booth 2221
    • Language: English

  • Packaging Line with Aggregation: A Project Management History

    04/02/2019, 11:30 AM - 12:30 PM, Javits Conventions Center - MG America - Booth 2221
    • Language: English

  • Sartorius Stedim

    04/02/2019, 11:30 AM - 12:15 PM, Javits Conventions Center - INNOPHEX Stage - Booth 3941
    • Language: English

  • Leveraging Technologies into the Smart Supply Chain

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

  • Single Use Centrifuge for Large Scale Separation and Collection of CHO and MABs, and Other Cell Culture Applications

    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 and filtration. The Biopharma Industry requir...

    • 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

  • MilliporeSigma: Using Single-use Technology to Enable Single-pass Tangential Flow Filtration

    04/02/2019, 1:00 PM - 1:30 PM, Javits Conventions Center - Stage 5, Booth 2477, Exhibit Hall

    Single-pass tangential flow filtration (SPTFF) has become a popular method of choice in bioprocessing for purposes of volume reduction, process intensification ...

    • Language: English

  • CRB Tech Tank: Evolution of the Revolution: The Future of Cell and Gene Therapy

    04/02/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall

    Advanced therapy medicinal product processes have fallen back on manual operations to accommodate the patient-specific scale, but what will these facilities loo...

    • Language: English

  • Pall Biotech

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

  • Piramal Pharma Solutions

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

  • Glass Vials Handling in Sterile Conditions: A Case History

    04/02/2019, 2:00 PM - 3:00 PM, Javits Conventions Center - MG America - Booth 2221
    • Language: English

  • SP Scientific/Penntech: From Formulation to Full Commercialization: Scaling up with Line of Sight

    04/02/2019, 2:00 PM - 2:30 PM, Javits Conventions Center - Stage 5, Booth 2477, Exhibit Hall

    SP Scientific is a leading manufacturer of freeze dryers and aseptic fill-finish equipment. The company's Line of Sight approach provides a breakthrough suite o...

    • Language: English

  • CRB Tech Tank: From Blank Paper to a State of the Art Phase 3 / Commercial Gene Therapy Manufacturing Facility

    04/02/2019, 2:15 PM - 3:00 PM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall

    Paragon Bioservices Inc., a biologics Contract Development and Manufacturing Organization (CDMO) located in downtown Baltimore, has been experiencing considerab...

    • Language: English

  • Terumo BCT: Downstream Processing Challenges in Cell Therapy Manufacturing

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

    With the recent FDA approval of the CAR-T cell therapies Kymriah® from Novartis and Yescarta® from Kite Pharma there has been a renewed interest in bioprocessin...

    • 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

  • Advantages of Standardized and Fully Integrated Automation Solutions for Processing & Packaging Lines

    04/02/2019, 3:00 PM - 4:00 PM, Javits Conventions Center - MG America - Booth 2221
    • Language: English

  • BOSCH Packaging Technology: Xelum®, Latest Insights into the New Bosch Continuous Manufacturing Platform

    04/02/2019, 3:00 PM - 3:30 PM, Javits Conventions Center - Stage 5, Booth 2477, Exhibit Hall

    The suitability of the Xelum® continuous manufacturing technology for small-scale batches from 1 to 100 kg will be demonstrated. Furthermore, the new benchmark ...

    • Language: English

  • CRB Tech Tank: Isolators for Cell and Gene Therapy

    04/02/2019, 3:15 PM - 4:00 PM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall

    The industry is changing fast in the cell and gene therapy arena. Producers are changing their approach from biosafety cabinets to isolators. CRB's aseptic proc...

    • Language: English

  • Esco Technologies Inc: Novel Bioprocessing Strategies for Cell/Gene Therapy and Biomedical Engineering

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

    In the cell and gene therapy modality there is often a debate on scaling up versus scaling out. Whilst there are multiple multi layered culture ware with auto...

    • 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

  • Antares Vision North America

    04/02/2019, 4:00 PM - 4:30 PM, Javits Conventions Center - Stage 5, Booth 2477, Exhibit Hall
    • Language: English

  • INNOPHEX Reception Sponsored by Germfree

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

    This is your opportunity to enjoy a networking reception within the newly formed INNOPHEX.

    • Language: English

  • Therapure Biopharma

    04/02/2019, 4:15 PM - 5:00 PM, Javits Conventions Center - 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

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