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

Aseptic Conference 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

The presentation will focus mainly on opportunities but also challenges linked to the usage of disposable technologies in starting-up an aseptic facility for formulation filling and inspection of biopharmaceutical products. A case study about product transfer will be presented.

A Successful Clinical, Multi-Product Fill & Finish Operation
Tuesday, 7 March 11:00 - 11:30

Clinical manufacturing as compared to commercial manufacturing requires much shorter timelines, higher batch yields and higher flexibility. This case study presents an in-depth view on setting up and operating a clinical manufacturing fill-and-finish operation, designed specifically for small-scale, high value batch production. It will examine how the appropriate use of disposables enables time and cost efficiencies, fast capacity increases and high flexibility. It will also identify some challenges associated with the use of disposables and offer some solutions to achieve success.

Single-Use Systems in Fill-Finish
Tuesday, 7 March 11:30 - 12:00

Case Studies for Protein Drug Products
Tuesday, 7 March 12:00 - 12:30

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

This presentation addresses the need to standardize aspects of product lifecycle management of single-use systems. Participants will understand the tools developed and intent of the BPOG and BPSA joint efforts in terms of change control and user requirements specification. They will also be encouraged to provide feedback and adapt the tools and principles which are intended to be incorporated in future versions of ASME-BPE and ASTM pertinent standards.

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

Pharmaceutical industries heavily rely on their suppliers' quality of single-use materials. This presentation will address the approaches to quality risk management when using the single-use system for manufacturing of biologics.

Can Single Use Components be Commodities?
Wednesday, 8 March 10:00 - 10:40

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
    Dance Floor Approach & Single-Use Standardisation

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

AbbVie decided to invest in a completely new machine, which was not available at that time • therefore engineering of a prototype machine was required. This resulted in a collaboration with a reknown and capable partner. The machine will be qualified around April 2017.

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

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

Barrier Sessions

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

The presentation will review the process of how gaps in the project aseptic technique program were determined and the solutions developed to improve both aseptic technique and ergonomics within the packaging isolator.

Utilizing Low Energy Electron Beam Technology for Aseptic Transfer of Pre-Sterilized Nested Tubs
Tuesday, 7 March 11:00 - 11:30

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
  • Christa Myers, Senior Pharmaceutical Engineering Specialist, CRB, USA
    ADC/HPAPI Aseptic Processing Fill and Finish: View from a CMO

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

  • Massimiliano Cesarini, PhD, Global Sales Mgr Isolation Tech Div, Comecer Group, Italy
    Barrier Technology Evolution in Bulk Sterile Manufacturing

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

Cook Pharmica's execution of the flexible filling line project demonstrates a unique and bold vision. The collaborative project not only achieves exceptional capability for Cook Pharmica, but also progresses two important trends in the pharmaceutical industry: flexibility in advanced aseptic manufacturing and increased availability of ready-to-use components.

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

To establish the facilities for multi-highly potent parenteral products, it would be required to balance competing concepts for aseptic processing and containment strategies, applying the risk based approach. Our topic would address the risk based manufacturing for multi-highly potent parenteral products introducing the actual practice of lyophilized products with aseptic/washable isolators.

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

The presentation covers the individual steps on Isolator Technology starting in the pioneer days in the early 1990's up to nowadays 21st century Isolators with focus on the design influence for biodecontamination cycle times.

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

Installation of a flexible, nested syringe and vial filling line, with isolator, at Amgen's HQ campus provided greater flexibility within an existing drug substance manufacturing facility.

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

Glove management shall be performed with a holistic approach, considering risks in contamination transfer through glove holes. A strategy for glove management is presented including different approaches for barrier systems such as isolators and RABS.

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

Overview of developing guidance on Environmental control and EM Process monitoring applied to Project candidate Case studies and presented as a documentation package as full worked examples. Seven topics are covered in the case studies including: Cleaning/Disinfection, Gowning/Garbing for Aseptic processing, Environmental Classification, Risk assessments for EM sample locations, EM programs for Media Fills, Routine Production EM, End of batch surface sampling, EM sample incubation regime based on targeted approach, Barrier system Glove Management.

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

AqVida has designed a flexible, zero-loss filling system using robotic arms inside isolators. The main reason for the use of robotic arms is to minimize interventions inside the isolators, since the interventions are the main causes of contamination and failure. Compared to conventional system, this new system has significantly cut down on the frequency and time of interventions required for a production.

Barrier Track Discussion Groups
Wednesday, 8 March 13:00 - 14:30

  • Leader: Massimiliano Cesarini, PhD, Global Sales Mgr Isolation Tech Div, Comecer Group, Italy
  • Leader: Richard Denk, Head Sales Containment, SKAN AG, Switzerland
    Evolutionary Advantages in Containment Isolators
  • Leader: James Drinkwater, Chairman of PHSS & Head of Aseptic Processing Technologies, Franz Ziel GmbH, Germany
    Environmental Process Monitoring Discussion
  • Leader: Alexander Haig, Director, Engineering, Cook Pharmica, LLC, USA
    Flexible Filling Using Disposable Components
  • Leader: Corinna Maier, Deputy Head of Aseptic Processing Technologies and GMP Compliance, Franz Ziel Gmbh, Germany
    Barrier Technology Glove Management- Discussion Group
  • Leader: Dwight You, Head of Production, AqVida GmbH, Germany
    AqVida Robotic Fill-Finish Systems in Isolators: Discussion Group

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

  • Leader: Massimiliano Cesarini, PhD, Global Sales Mgr Isolation Tech Div, Comecer Group, Italy
  • 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

Conference Welcome and Opening Keynote
Tuesday, 7 March 08:30 - 09:45

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

Industry Panel: How to Reach the Point of Fill- Introduction Techniques into the Aseptic Core Area
Tuesday, 7 March 16:00 - 17:30

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

This presentation will provide a brief overview of the changes/updates to the guide; and primarily focus on the extensive feedback received from the industry.

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

We will explore the multitude of factors underlying shortages of aseptic products based upon recent studies of the issue, as well as provide real life examples of issues facing aseptic manufacturers that may influence their ability to remain compliant and assure continuous supplies of medicines essential for public health.

General Session: 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, Invited
  • 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  Conference Welcome and Opening Keynote
  • Thomas Arista, Consumer Safety Officer, FDA/ORA/ORO/DMPTO, USA
    What I Learned As Regulator Through Years of International Inspections
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  Utilizing Low Energy Electron Beam Technology for Aseptic Transfer of Pre-Sterilized Nested Tubs
11:00 - 11:30  A Successful Clinical, Multi-Product Fill & Finish Operation
11:30 - 12:00  Single-Use Systems in Fill-Finish
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
  • Christa Myers, Senior Pharmaceutical Engineering Specialist, CRB, USA
    ADC/HPAPI Aseptic Processing Fill and Finish: View from a CMO
12:00 - 12:30  Flexible, Multi-Product Sterile Facility
  • Massimiliano Cesarini, PhD, Global Sales Mgr Isolation Tech Div, Comecer Group, Italy
    Barrier Technology Evolution in Bulk Sterile Manufacturing
12:00 - 12:30  Case Studies for Protein Drug Products
12:30 - 13:30  Lunch in Exhibit Hall
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 in Exhibit Hall
16:00 - 17:30  Industry Panel: How to Reach the Point of Fill- Introduction Techniques into the Aseptic Core Area
17:30 - 19:00  Networking Reception in the Exhibit Hall

Wednesday, 8 March

07:45 - 08:30  Special Morning Session: Discussion 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 in Exhibit Hall
10:00 - 10:30  Amgen Thousand Oaks Building 20 Nested Syringe and Vial Clinical Line - Engineering Case Study
10:00 - 10:40  Can Single Use Components be Commodities?
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
    Dance Floor Approach & Single-Use Standardisation
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 in Exhibit Hall
13:00 - 14:30  Barrier Track Discussion Groups
  • Leader: Massimiliano Cesarini, PhD, Global Sales Mgr Isolation Tech Div, Comecer Group, Italy
  • Leader: Richard Denk, Head Sales Containment, SKAN AG, Switzerland
    Evolutionary Advantages in Containment Isolators
  • Leader: James Drinkwater, Chairman of PHSS & Head of Aseptic Processing Technologies, Franz Ziel GmbH, Germany
    Environmental Process Monitoring Discussion
  • Leader: Alexander Haig, Director, Engineering, Cook Pharmica, LLC, USA
    Flexible Filling Using Disposable Components
  • Leader: Corinna Maier, Deputy Head of Aseptic Processing Technologies and GMP Compliance, Franz Ziel Gmbh, Germany
    Barrier Technology Glove Management- Discussion Group
  • Leader: Dwight You, Head of Production, AqVida GmbH, Germany
    AqVida Robotic Fill-Finish Systems in Isolators: Discussion Group
13:00 - 14:30  Aseptic Workshop: Leachables and Extractables Are Not the Same (Part 1)
14:30 - 15:00  Networking Break in Exhibit Hall
15:00 - 15:30  Aseptic Workshop: Leachables and Extractables Are Not the Same (Part 2)
15:00 - 15:30  Barrier Track Discussion Group Report Outs
  • Leader: Massimiliano Cesarini, PhD, Global Sales Mgr Isolation Tech Div, Comecer Group, Italy
  • 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  General Session: 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, Invited
  • 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:

Note:  Presentations will be available until 8 September 2017

2018 Aseptic Conference

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