2017 Aseptic Conference, 07-08 March, Hyatt Regency, Reston VA

Education Program

The 2017 Aseptic Conference will bring together speakers from more than 30 companies ( 99 KB), to present the latest technology updates from industry leaders worldwide. Also, don’t miss the regulatory panel session, a unique opportunity to hear from and interact with experts from the FDA. The two-day conference will feature an impressive line-up of concurrent sessions for Aseptic and Barrier technology.

Aseptic Track will present trends in aseptic processing and disposable technology. Attendees will be able to revisit their own processes, and potentially implement new ideas or modify their processes to meet current and coming standards.

Barrier Track attendees will learn from global industry experts, through RABS and Isolator case studies, why conventional clean-room process equipment is no longer “state of the art” for aseptic processing due to increased product contamination risk compared with properly used RABS and Isolators.

Click on each track for session information and details:

Education Details by Track Expand all

Aseptic Sessions

Usage of Disposable Technologies in New Sterile Operation Facilitiy
Tuesday, 7 March 10:30 - 11:00

Small-Scale Clinical Filling Using Disposables
Tuesday, 7 March 11:00 - 11:30

New Directions in Biotech Facility Design Using Disposables
Tuesday, 7 March 11:30 - 12:00

  • Niels Guldager, CPIP, Global Technology Partner, NNE Pharmaplan A/S, Denmark
    New Directions in Biotech Facility Design Using Disposables

Process Designs Using Disposables
Tuesday, 7 March 12:00 - 12:30

  • Shakir Muradymov, Process Engineer, MedImmune/AstraZeneca, USA
    Process Designs Using Disposables

The Value of Our Interactions as an Industry
Tuesday, 7 March 13:30 - 14:15

Quality Assurance for Biologics Manufacturing with Single Use Systems
Tuesday, 7 March 14:15 - 15:00

A Roadmap to Single Use Implementation in Fill/ Finish Applications
Wednesday, 8 March 10:00 - 10:40

  • Christian Matz, PhD, Global Project Manager, Hoffmann-la Roche, Switzerland

Standardisation of Single Use Equipment for Fermentation, Purification, and Fill-Finish
Wednesday, 8 March 10:40 - 11:20

  • David Wolton, Biopharma Consultant, PM Group, Ireland
    Standardisation of Single Use Equipment for Fermentation, Purification, and Fill-Finish (Lessons Learned: from the Ballroom to the Dance Floor)

Building a Machine for the Future
Wednesday, 8 March 11:20 - 12:00

Workshop: Leachables and Extractables Are Not the Same (Part 1)
Wednesday, 8 March 13:00 - 14:30

Workshop: Leachables and Extractables Are Not the Same (Part 2)
Wednesday, 8 March 15:00 - 15:30

  • Malik Belattar, Founder and CEO, Pharma Biot'Expert, France
  • Yuk Chun Chiu, Director of Manufacturing and Engineering, Pearl Therapeutics, Inc., USA
  • Christopher Smalley, Pharmaceutical Consultant, Retired, USA

Barrier Sessions

Case Study Lessons Learned from the Start up of a Packaging Isolator
Tuesday, 7 March 10:30 - 11:00

Baxter's New Fill-Finish-Lyo Facility in Marietta, GA
Tuesday, 7 March 11:00 - 11:30

  • Brant Bulgarelli, Engineering Specialist, Baxalta Healthcare, USA
    Baxter's New fill-finish-lyo facility in Marietta, GA

ADC/HPAPI Aseptic Processing Fill and Finish: View from a CMO
Tuesday, 7 March 11:30 - 12:00

  • Richard Denk, Head Sales Containment, SKAN AG, Switzerland
    ADC/HPAPI Aseptic Processing Fill and Finish: View from a CMO
  • Stacy Sutton, Senior Director Fill/Finish, Althea Technologies, USA
    ADC/HPAPI Aseptic Processing Fill and Finish: View from a CMO

Flexible, Multi-Product Sterile Facility
Tuesday, 7 March 12:00 - 12:30

  • Douglas Bryans, PhD, Chief Operating Officer, Bryllan LLC, USA
    Flexible, Multi-Product Sterile Facility

Flexible Filling: Ready or Not, Ready-to-Use Vials
Tuesday, 7 March 13:30 - 14:00

How to Achieve Both Sterility and Containment for Large-Scale Isolator Filling/Lyophization Lines
Tuesday, 7 March 14:00 - 14:30

Evolution of Isolator Technology Over the Last Decades and its Influence on Biodecontamination Cycle Times
Tuesday, 7 March 14:30 - 15:00

Amgen Thousand Oaks Building 20 Nested Syringe and Vial Clinical Line - Engineering Case Study
Wednesday, 8 March 10:00 - 10:30

Barrier Technology Glove Management - Considering Risks in Contamination Transfer
Wednesday, 8 March 10:30 - 11:00

Overview of PHSS Initiative to Develop Guidance for Environmental Control and EM Process Monitoring
Wednesday, 8 March 11:00 - 11:30

Robotic Fill-Finish Systems in Isolators
Wednesday, 8 March 11:30 - 12:00

Break-Out Discussion Groups
Wednesday, 8 March 13:00 - 14:30

  • Leader: Douglas Bryans, PhD, Chief Operating Officer, Bryllan LLC, USA
    Pioneering Designs of Multi-Product Facilities to Optimize Capital Assets and Product Segregation
  • Leader: Richard Denk, Head Sales Containment, SKAN AG, Switzerland
    Evolutionary Advances in Containment Isolators
  • Leader: James Drinkwater, Chairman of PHSS & Head of Aseptic Processing Technologies, Franz Ziel GmbH, Germany
    Isolator Environmental Monitoring and Process Monitoring
  • Leader: Alexander Haig, Director, Engineering, Cook Pharmica, LLC, USA
    Flexible Combi-Filling Lines using Disposable Components
  • Leader: Corinna Maier, Deputy Head of Aseptic Processing Technologies and GMP Compliance, Franz Ziel Gmbh, Germany
    Glove Management
  • Leader: Dwight You, Head of Production, AqVida GmbH, Germany
    Isolator Robotic Filling Systems

Discussion Group Report Outs
Wednesday, 8 March 15:00 - 15:30

  • Leader: Douglas Bryans, PhD, Chief Operating Officer, Bryllan LLC, USA
    Pioneering Designs of Multi-Product Facilities to Optimize Capital Assets and Product Segregation
  • Leader: Richard Denk, Head Sales Containment, SKAN AG, Switzerland
    Evolutionary Advances in Containment Isolators
  • Leader: James Drinkwater, Chairman of PHSS & Head of Aseptic Processing Technologies, Franz Ziel GmbH, Germany
    Isolator Environmental Monitoring and Process Monitoring
  • Leader: Alexander Haig, Director, Engineering, Cook Pharmica, LLC, USA
    Flexible Combi-Filling Lines using Disposable Components
  • Leader: Corinna Maier, Deputy Head of Aseptic Processing Technologies and GMP Compliance, Franz Ziel Gmbh, Germany
    Glove Management
  • Leader: Dwight You, Head of Production, AqVida GmbH, Germany
    Isolator Robotic Filling Systems

General Sessions

Keynote Session
Tuesday, 7 March 08:30 - 09:45

  • Thomas Arista, Consumer Safety Officer, FDA/ORA/ORO/DMPTO, USA, Invited
    What I Learned As Regulator Through Years of International Inspections

Industry Panel Discussion: How to Reach the Point of Fill
Tuesday, 7 March 16:00 - 17:30

Special Morning Session: Discussion on the Updated Sterile Facilities Guide
Wednesday, 8 March 07:45 - 08:30

  • Jason Collins, AIA, Dir. Process Architecture, IPS, USA
    Discussion on Comments Received on the Updated Sterile Facilities Guide
  • Gordon Leichter, PhD, Sales Manager, Belimed, Inc., USA
    Discussion on Comments Received on the Updated Sterile Facilities Guide
  • Matthew VonEsch, Sr. Director, Manufacturing, Exelead BioPharma, USA
    Discussion on Comments Received on the Updated Sterile Facilities Guide

Special Session: ISPE-PEW Drug Shortages Research Report Release
Wednesday, 8 March 08:30 - 09:15

Regulatory Panel
Wednesday, 8 March 15:30 - 17:00

  • Rebecca Dombrowski, Facility Reviewer, FDA/CDER/OPQ/OPF/DIA, USA
  • Lynne Ensor, PhD, Division Director (Acting), FDA/CDER/OPQ/OPF/DMA, USA
  • Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
  • Robert Sausville, Director, Div. Case Management, FDA/CBER/OMPT/OCBQ, USA
  • Jeremy Wally, CDR, PhD, Director Regulatory Operations Officer, FDA/CBER/OCBQ/DMPQ/BII, USA

Daily Schedule

Tuesday, 7 March

08:30 - 09:45  Keynote Session
  • Thomas Arista, Consumer Safety Officer, FDA/ORA/ORO/DMPTO, USA, Invited
    What I Learned As Regulator Through Years of International Inspections
09:45 - 10:30  Networking Break
10:30 - 11:00  Usage of Disposable Technologies in New Sterile Operation Facilitiy
10:30 - 11:00  Case Study Lessons Learned from the Start up of a Packaging Isolator
11:00 - 11:30  Baxter's New Fill-Finish-Lyo Facility in Marietta, GA
  • Brant Bulgarelli, Engineering Specialist, Baxalta Healthcare, USA
    Baxter's New fill-finish-lyo facility in Marietta, GA
11:00 - 11:30  Small-Scale Clinical Filling Using Disposables
11:30 - 12:00  New Directions in Biotech Facility Design Using Disposables
  • Niels Guldager, CPIP, Global Technology Partner, NNE Pharmaplan A/S, Denmark
    New Directions in Biotech Facility Design Using Disposables
11:30 - 12:00  ADC/HPAPI Aseptic Processing Fill and Finish: View from a CMO
  • Richard Denk, Head Sales Containment, SKAN AG, Switzerland
    ADC/HPAPI Aseptic Processing Fill and Finish: View from a CMO
  • Stacy Sutton, Senior Director Fill/Finish, Althea Technologies, USA
    ADC/HPAPI Aseptic Processing Fill and Finish: View from a CMO
12:00 - 12:30  Flexible, Multi-Product Sterile Facility
  • Douglas Bryans, PhD, Chief Operating Officer, Bryllan LLC, USA
    Flexible, Multi-Product Sterile Facility
12:00 - 12:30  Process Designs Using Disposables
  • Shakir Muradymov, Process Engineer, MedImmune/AstraZeneca, USA
    Process Designs Using Disposables
12:30 - 13:30  Lunch
13:30 - 14:00  Flexible Filling: Ready or Not, Ready-to-Use Vials
13:30 - 14:15  The Value of Our Interactions as an Industry
14:00 - 14:30  How to Achieve Both Sterility and Containment for Large-Scale Isolator Filling/Lyophization Lines
14:15 - 15:00  Quality Assurance for Biologics Manufacturing with Single Use Systems
14:30 - 15:00  Evolution of Isolator Technology Over the Last Decades and its Influence on Biodecontamination Cycle Times
15:00 - 16:00  Networking Break
16:00 - 17:30  Industry Panel Discussion: How to Reach the Point of Fill
17:30 - 19:00  Welcome Reception in the Exhibit Hall

Wednesday, 8 March

07:45 - 08:30  Special Morning Session: Discussion on the Updated Sterile Facilities Guide
  • Jason Collins, AIA, Dir. Process Architecture, IPS, USA
    Discussion on Comments Received on the Updated Sterile Facilities Guide
  • Gordon Leichter, PhD, Sales Manager, Belimed, Inc., USA
    Discussion on Comments Received on the Updated Sterile Facilities Guide
  • Matthew VonEsch, Sr. Director, Manufacturing, Exelead BioPharma, USA
    Discussion on Comments Received on the Updated Sterile Facilities Guide
08:30 - 09:15  Special Session: ISPE-PEW Drug Shortages Research Report Release
09:15 - 10:00  Networking Break
10:00 - 10:30  Amgen Thousand Oaks Building 20 Nested Syringe and Vial Clinical Line - Engineering Case Study
10:00 - 10:40  A Roadmap to Single Use Implementation in Fill/ Finish Applications
  • Christian Matz, PhD, Global Project Manager, Hoffmann-la Roche, Switzerland
10:30 - 11:00  Barrier Technology Glove Management - Considering Risks in Contamination Transfer
10:40 - 11:20  Standardisation of Single Use Equipment for Fermentation, Purification, and Fill-Finish
  • David Wolton, Biopharma Consultant, PM Group, Ireland
    Standardisation of Single Use Equipment for Fermentation, Purification, and Fill-Finish (Lessons Learned: from the Ballroom to the Dance Floor)
11:00 - 11:30  Overview of PHSS Initiative to Develop Guidance for Environmental Control and EM Process Monitoring
11:20 - 12:00  Building a Machine for the Future
11:30 - 12:00  Robotic Fill-Finish Systems in Isolators
12:00 - 13:00  Lunch
13:00 - 14:30  Break-Out Discussion Groups
  • Leader: Douglas Bryans, PhD, Chief Operating Officer, Bryllan LLC, USA
    Pioneering Designs of Multi-Product Facilities to Optimize Capital Assets and Product Segregation
  • Leader: Richard Denk, Head Sales Containment, SKAN AG, Switzerland
    Evolutionary Advances in Containment Isolators
  • Leader: James Drinkwater, Chairman of PHSS & Head of Aseptic Processing Technologies, Franz Ziel GmbH, Germany
    Isolator Environmental Monitoring and Process Monitoring
  • Leader: Alexander Haig, Director, Engineering, Cook Pharmica, LLC, USA
    Flexible Combi-Filling Lines using Disposable Components
  • Leader: Corinna Maier, Deputy Head of Aseptic Processing Technologies and GMP Compliance, Franz Ziel Gmbh, Germany
    Glove Management
  • Leader: Dwight You, Head of Production, AqVida GmbH, Germany
    Isolator Robotic Filling Systems
13:00 - 14:30  Workshop: Leachables and Extractables Are Not the Same (Part 1)
14:30 - 15:00  Networking Break
15:00 - 15:30  Workshop: Leachables and Extractables Are Not the Same (Part 2)
  • Malik Belattar, Founder and CEO, Pharma Biot'Expert, France
  • Yuk Chun Chiu, Director of Manufacturing and Engineering, Pearl Therapeutics, Inc., USA
  • Christopher Smalley, Pharmaceutical Consultant, Retired, USA
15:00 - 15:30  Discussion Group Report Outs
  • Leader: Douglas Bryans, PhD, Chief Operating Officer, Bryllan LLC, USA
    Pioneering Designs of Multi-Product Facilities to Optimize Capital Assets and Product Segregation
  • Leader: Richard Denk, Head Sales Containment, SKAN AG, Switzerland
    Evolutionary Advances in Containment Isolators
  • Leader: James Drinkwater, Chairman of PHSS & Head of Aseptic Processing Technologies, Franz Ziel GmbH, Germany
    Isolator Environmental Monitoring and Process Monitoring
  • Leader: Alexander Haig, Director, Engineering, Cook Pharmica, LLC, USA
    Flexible Combi-Filling Lines using Disposable Components
  • Leader: Corinna Maier, Deputy Head of Aseptic Processing Technologies and GMP Compliance, Franz Ziel Gmbh, Germany
    Glove Management
  • Leader: Dwight You, Head of Production, AqVida GmbH, Germany
    Isolator Robotic Filling Systems
15:30 - 17:00  Regulatory Panel
  • Rebecca Dombrowski, Facility Reviewer, FDA/CDER/OPQ/OPF/DIA, USA
  • Lynne Ensor, PhD, Division Director (Acting), FDA/CDER/OPQ/OPF/DMA, USA
  • Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
  • Robert Sausville, Director, Div. Case Management, FDA/CBER/OMPT/OCBQ, USA
  • Jeremy Wally, CDR, PhD, Director Regulatory Operations Officer, FDA/CBER/OCBQ/DMPQ/BII, USA

Event Sponsors

Presentations & Attendee Roster

Conference Attendees:

2017 Aseptic Conference Brochure
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