Before the Event
17 March 2019
Day 1
18 March 2019
  • 0730 - 1830
    Registration Open
  • 0900 - 1015
    Keynote Session
    Session Leaders
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    [The State of Aseptic Processing: Current Findings and Learnings]
    Speaker: Richard Friedman
    Speakers
    Deputy Director, Science and Regulatory Policy
    FDA/CDER
  • 1015 - 1100
    Networking Break in Expo Hall
  • 1015 - 1815
    Expo Hall Open
  • 1100 - 1230
    Advanced Technologies for Legacy & Future Facilities
    The first session of the Barrier Track will be a future-oriented, in-depth examination of advanced aseptic technology and how it is being applied in three different situations: the first, how it was used to modernize a legacy sterile manufacturing facility; the second, a look into the "EM crystal ball" at a proposed, standardized, risk-based EM (Environmental Monitoring) procedure; and third, a detailed description of sterile facilities of the future using the most advanced aseptic technology available to achieve reliability and patient-first, robust compliance.
    Session Leaders
    Principal Process Engineer
    O'Neal Inc.
    [High-Speed Filler using Bags of Pre-sterilized Plastic Components and a Unique Approach to Sterile Drum Coning]
    Speaker: Walter Senour
    The paper will detail Design from concept drawings to mock-up, fabrication to pre-FAT and FAT, to the installation and start-up of an Isolator based high Speed filling line for a veterinary product. Several management keys and process checks are discussed to ensure success during the project. Pre-Sterilized component bags are connected to the process by docking isolators and loose fed into the line. The line fills and assembles syringes at 380 spm.

    A bonus presentation details the design and execution of unique sterile drum coning isolator. Sterile drums of API have there lids removed and replaced with cones that have integrated valving to allow aseptic addition of API to a formulation process. || [Learning from Today’s Facilities to Plan for Tomorrow: The Aseptic Manufacturing Facility of the Future]
    Speaker: Jason Collins, AIA
    Speakers
    Retired
    Retired
    Director, Process Architecture
    IPS
  • 1100 - 1230
    Aseptic Cell & Gene Therapy
    Cell-and gene-therapy production systems are a challenge for manufacturing operations as the requirements are different from traditional aseptic fill-finish. This might involve the culture of modified live cells and batch sizes of 1 batch per patient, as the dosage is stratified. This session will cover case-studies from recently completed projects in this field, including lessons learned and an outlook to things to come.
    Session Leaders
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    [A Cell Culture GMP Facility of the Future Implemented in the Present]
    Speakers: Andreas Eberle, PhD and Massimiiano Cesarini || [Advanced Therapy Facility Design]
    Speakers: Erich Bozenhardt & Tristan Wilkins
    Manufacturing facilities for cell and gene therapies are facing numerous challenges: therapies failing in clinical trials leaving abandoned assets, processes that are manual and not easily scaled out, and no long term industry platform to leverage. Facilities need to consider phased implementation, the ability to adjust to process development, segregation/efficiency balance and the logistics of small (many times one patient) batch sizes. These processes and facilities must evolve together to deliver on the potential of this class of therapies. This presentation will assess the array of therapies against the best practices and case studies of process / facility evolution.
    Speakers
    Placeholder Person Graphic
    Vice President, Head of Global Manufacturing
    Codon AG
    Placeholder Person Graphic
    SGI Project Director
    Lonza
    Process Manager
    Integrated Project Services
    Global Sales Manager- Isolation Technology Division
    Comecer Group
  • 1100 - 1230
    Cross Contamination in Shared Equipment/Facilities
    According to industry projections, by 2025 every other new Biopharma Product will be considered a highly potent/toxic product. Smaller batches, personalized medicine, and a high demand to prevent cross contamination will be the challenges for aseptic processing in the future.
    Session Leaders
    Head, Sales Containment
    SKAN AG
    Senior Pharmaceutical Engineering Specialist
    CRB
    [The Value of Containment Technology: A Comprehensive Business Case for Driving Implementation]
    Speaker: David Eherts, PhD
    This presentation will cover current and rapidly evolving containment technologies and present the business case for their timely implementation. The myriad areas of business value will be summarized, incorporating case studies that quantify precisely the return-on-investment for these technologies. Finally, a vision for the future of pharmaceutical manufacturing technology incorporating the inherent benefits of containment will be presented. || [ADCs, High Potent Aseptic Filling]
    Speakers: Wolfgang Lau and Hartmut Schaz
    Speakers
    Placeholder Person Graphic
    VP Global EHS
    Allergan Plc
    Head, Sales Containment
    SKAN AG
    Global Technology Partner
    NNE
    Placeholder Person Graphic
    Project Manager
    Roche Diagnostics GmbH
  • 1230 - 1330
    Lunch in Expo Hall
  • 1330 - 1500
    Facility Upgrades & Expansions
    This session will be a triple-hitter program of world-class case studies about UPGRADES from three industry leaders: Fresinius-Kabi, Grand River Aseptic Manufacturing and Robert Bosch. The first will showcase a major expansion project at Melrose Park, NY with emphasis upon challenges and lessons learned. The second will detail a soup-to-nuts overview how a small, CMO, legacy sterile manufacturing facility was upgraded and expanded into a medium-sized, greenfield facility using Advanced Aseptic Technology (isolators, closed processing and RTU components). The third will roll out two case studies covering containment of sterile products and how a CMO grew from a small legacy facility into a world-class medium-sized facility.
    Session Leaders
    Principal Process Engineer
    O'Neal Inc.
    [Melrose Park Expansion Project: A Story of Growth and Evolution]
    Speaker: Jean Allaume
    This presentation include multiple challenges that other companies may also have to face :
    - upgrade an aging site with new technology
    - Integrate a new building within an existing site
    - Prepare the start-up and manage the transition of the workforce
    The benefit for the attendees came from the lesson learned and success factors. || [Case Studies to Upgrade Legacy Facilities for Sterile and Containment Products]
    Speaker: Jürgen Michael Metzger
    || [GRAM Case Study of a Green Field Isolator Filling-Lyo Facility, Grand Rapids, MI]
    Speaker: Ryan Waldhart
    The presentation will introduce a case study for a green field isolator filling and lyophilization facility expansion project. The new facility will contain state of the art processing equipment for filling, lyophilization, and will utilize isolator technology. Topics will include the project scope, current project status, and future project plans and goals. Attendees will benefit from discussions regarding facility design, the filler isolator equipment selection process , and the transition from conventional cleanroom to advanced aseptic processing technology in a CMO facility. || [GRAM Case Study of a Green Field Isolator Filling-Lyo Facility, Grand Rapids, MI]
    Speakers: Ryan Waldhart and Hite Baker
    Speakers
    Sr. Director, MP Expansion Project
    Fresenius Kabi USA LLC
    Placeholder Person Graphic
    Barrier Systems & Process Specialist
    Robert Bosch Packaging Technology GmbH
    Manufacturing Technical Specialist
    Grand River Aseptic Manufacturing
    Principal Process Engineer
    O'Neal Inc.
  • 1330 - 1500
    Disposables
    Disposable equipment continues to revolutionize production, and great advancements continue in the field. The audience will learn from recent transformation projects, where moving from stainless steel to disposables has helped to de-bottleneck operations. Advances in fluoropolymer films help solve problems with leaking bags, while the material can be gamma-sterilized for the first time. Challenges and how to overcome them in terms of managing the supply chain and the change management for disposable equipment will also be discussed.
    Session Leaders
    Senior Product Manager
    Robert Bosch Packaging Technology GmbH
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    [Cleaning Validation of Single Use Systems for Use in Drug Product Filling Applications]
    Speaker: Laura Moody, PhD (in collaboration with Amgen)
    Biopharmaceutical manufacturers are motivated to select single-use final fill assemblies for their processes based upon a number of factors, primarily reductions in risk and costs connected to their products, facilities, equipment, and the substantial mitigation of batch-to-batch carryover. Additionally, high risks and costs associated with non-SUS operations such as CIP/SIP and post-batch exposure to toxic biohazardous substances can be markedly reduced. Therefore the terms “cleaning” and “single-use” seem contradictory in this context. However, cleaning (and associated validations) may be indicated for SUS components that may become contaminated during manufacturing. For example, cutting fluids, lubricants, passivation agents, and particulate matter must be completely removed prior to use. These cleaning processes must be appropriately designed, qualified, and potential sources of variability controlled commensurate with the risk they represent. || [Using Disposables to De-bottleneck a Facility]
    Speaker: Kamyar Moftakhar
    || [Advancements in Fluoropolymer Single Use Systems]
    Speaker: Eric Isberg
    Speakers
    Product Manager, Single-Use Systems
    Robert Bosch Packaging Technology
    Placeholder Person Graphic
    Process Engineer
    Genentech Inc
    Director, Life Sciences
    Entegris
  • 1330 - 1500
    Cross Contamination in shared Equipment/ Facilities
    Session Leaders
    Head, Sales Containment
    SKAN AG
    Senior Pharmaceutical Engineering Specialist
    CRB
    [Case Study: Intro of Manufacturing Facilities for Highly Potent Lyophilization Sterile Products]
    Speaker: Ken Nagai
    Development of both Containment and Sterile manufacturing facilities is a hot topic in the midst of increasing needs for bio medicine and anti cancer drugs. By providing real world case studies in establishing Containment & Sterile facilities from perspectives of both pharmaceutical company's and process equipment company's. We believe audience can take away some application insights for their facility development and operation. || [Automated Cleaning of Parts in HAPI Production ]
    Speaker: Michael Kradolfer
    || [Case Study: Introduction of Manufacturing Facilities for Highly Potent Lyophilization Sterile Products]
    Speaker: Tomoharu Takeda & Ken Nagai
    Nagase Medicals Co., Ltd. in Japan have established a new lyophilization production line for highly potent drugs. This line can maintain both sterility assurance of products as well as containment safety, both during production and maintenance. For this new lyophilization line we have applied a new filter technology. We have developed a new technology. We will explain some of the key features of the project:
    1. New layout design and HVAC system of both sterility and containment can be realized.
    2.Introduction a new exhaust filter system, “Split HEPA”. The filter is applied with PTFE material. The filter can resist water during cleaning / washing. || [Using Virtual Reality to prevent cross contamination in shared Equipment/ Facilities]
    Speakers: Mikael Lecocq and Andre Zdunczyk
    Traditional manufacturing is being challenged by Bio Pharma trends for highly potent/toxic products, smaller batches and personalized medication. Future aseptic processing will be subject to an increased amount of cross contamination. This has triggered cutting-edge companies to develop and implement virtual reality tools into the facility and equipment design phase of projects. This technology provides the client with a virtual overview of the facility and equipment layout, allowing the client to challenge and optimize their critical practices, train their operators in a safe environment and avoid the potential cross contamination risk which can occur once the equipment and facility become operational.
    Speakers
    Manager, New Business Development
    Airex Co., Ltd
    Placeholder Person Graphic
    General Manager,Technology Development
    Nagase Medicals Co.,Ltd
    Placeholder Person Graphic
    Nagase Medicals Co Ltd
    Sales Manager
    Bausch + Stroebel Machine Company
    Director of Operation, Industrial Division
    SNC-LAVALIN
  • 1500 - 1545
    Networking Break in Expo Hall
  • 1545 - 1715
    The Use of Robots in Aseptic Processing: Lessons Learned
    Session Leaders
    Senior Product Manager
    Robert Bosch Packaging Technology GmbH
    [Robotics in Aseptic Processing - A Paradigm Shift]
    Speaker: Kevin Owen
    People are the single biggest contributor to microbiological contamination in any cleanroom. This coupled to the increasingly complex and often highly potent products requires human interaction to be minimised as much as possible. Or even to eliminate people from the process altogether. Developing new technology and harnessing the power of Industry 4 will shortly be changing how we view aseptic processing and human involvement. We are about to enter an age of Robotic revolution, not evolution...
    Speakers
    Placeholder Person Graphic
    Corporate Vice President, Global Best Practice
    NNE
    Placeholder Person Graphic
    Process Mechanical Engineer
    Jacobs Engineering
    Global Aseptic Processing Subject Matter Expert
    PM Group
    Director, Process Technology
    IPS - Integrated Project Services, LLC
    President
    Genesis Engineers Inc
    Senior Pharmaceutical Engineering Specialist
    CRB
  • 1715 - 1815
    Networking Reception in Expo Hall
Day 2
19 March 2019
  • 0800 - 0900
    Breakfast Session
    Session Leaders
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    [Annex 1 Hot Topics: ISPE/Industry Thoughts ]
    Speaker: Jean-Francois Duliere
    Speakers
    Pharmacy Senior Consultant
    -
  • 0915 - 1000
    Keynote Session
    The use of robotics is a hot topic in pharma, particularly in the area of fill/finish. While robots are able to accomplish numerous tasks, in aseptic processing their use has been primarily limited to container handling, replacing a classical transport system. More and more experts are claiming this is not enough. Robotics can and should do more - like settle plate handling, trouble shooting, gloveless operation, quick change over, easy efficient cleaning/washing, increased product and Operator safety to name some of the possibilities.

    The need for expanding the use of robotic into a variety of functions was a key topic of discussion during last year's program, so we have designed this session to continue that conversation. You will have the opportunity to hear first-hand Bayer's perspective on robotics. Dr. Elise Abinet and Dr. Svenja Gutsche will present Bayer's intensive research findings on their filling line technology and equipment and the challenges they faced in meeting customer needs.
    Session Leaders
    Senior Product Manager
    Robert Bosch Packaging Technology GmbH
    [Transforming Aseptic Production Using Robotics: User Perspective]
    Speaker: Svenja Gutsche, PhD
    Speakers
    Regional Sites Coordinator for China and Korea
    Bayer AG
    Processes, Standards & Manufacturing IT, Bayer AG Pharmaceuticals - Product Supp
    Bayer AG
  • 1000 - 1045
    Networking Break in Expo Hall
  • 1000 - 1515
    Expo Hall Open
  • 1045 - 1215
    This final session of the Barrier Track should provide a strong finish to the program, offering three trending topics in the industry: addressing the challenges of legacy sterile facilities, "What about GLOVELESS isolator filling machines?" and how to achieve 6-sigma filling-dose control given flexible manufacturing challenges at a leading CMO including primary-component variability. These industry leaders promise not only to share their how-tos, but also to share the inside stories of mistakes-made and lessons-learned. The third and final session of the Barrier Track promises to wrap up with engineering insights from pioneering Owners of sterile facilities, insights that are a signature product of ISPE, in the service of owners, suppliers, engineers and regulators.
    Session Leaders
    Principal Process Engineer
    O'Neal Inc.
    [First Licensed VANRX Robotic Gloveless Filling Machine]
    Speakers: Brent Lieffers and Christa Myers
    Speakers
    Process Engineer
    Catalent Biologics
    Senior Director, Operations
    Singota Solutions
  • 1045 - 1215
    Robotics in Cleanrooms
    For over two decades, robots have helped to make the aseptic fill-finish processes safer by removing humans further from the process. While some applications merely substitute, others go further and finally make things possible that were not thought of before, like environmental monitoring. This session will feature case-studies from successful engineering projects, while not hiding the hard truths that had to be learned the way.
    Session Leaders
    Senior Product Manager
    Robert Bosch Packaging Technology GmbH
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    [Non-Invasive Sensors for Cell/Gene Therapy Manufacturing]
    Speaker: Govind Rao, PhD
    || [The Use of Collaborative Robots in Manufacturing]
    Speaker: Richard P. Aulenbach, PE
    This presentation will focus on significant aspects of the use of robots in Aseptic Manufacturing with a concentration in the sterile fill/finish arena.

    A brief array of potential types of robots will be discussed with areas of individual preferential use. The main thrust of the discussion will center on the use of collaborative robots due to their ability to safely work near personnel. An in depth review will be presented on the unique parameters of the application of multiple collaborative robots working in tandem, as well as the difficult task of two robots simultaneously grabbing and handling a single element in a sterile environment.

    All aspects of the application of robots in this environment will be explored as we present the successes and challenges of an actual project, from inception through selection criteria, to design development including; testing, implementation, and qualification. Critical areas of the project implementation will be reviewed such as acceptance testing, personnel safety, GAMP/SDLC compliance documentation, system reliability and operator interface. || [The latest topics and trend about the Rapid Microbial Monitoring Method (RMM)]
    Speaker: Koji Kawasaki & Aric Meares
    The presentation will discuss how this innovative microbial detection method works, the comparison to the traditional method, examples of end-user applications, and view of how US/EU regulatory trends. For case study, we will present you the RMM system monitoring at the actual filling line, with nearly two years of operation and continuous measurement of the bioburden inside the plastic container before filling.
    1. What is the latest technology of RMM and the trend of regulatory expectation?
    2.What are the results and installation issues on actual Grade A filling line?
    3.New procedures to perform continuously monitoring of the bio-positive particle inside individual containers to be filled.
    Speakers
    Placeholder Person Graphic
    Professor and Director, Center for Advanced Sensor Technology
    University of Maryland
    Executive Vice President
    BioVigilant
    Placeholder Person Graphic
    President & CEO
    RPA Engineering
    CEO
    Airex Co., Ltd.
  • 1045 - 1215
    Cross Contamination in shared Equipment/ Facilities
    Session Leaders
    Head, Sales Containment
    SKAN AG
    Senior Pharmaceutical Engineering Specialist
    CRB
    [Challenges of Selecting the Right Concept for a High Potent Aseptic Facility: from Material Dispensing to the Fill/Finished Product]
    Speaker: Christian Mrotzek
    || [Fully Automated Aseptic Processing for High Potent Substances]
    Speaker: Terrence Hollis
    || [Flexible Zero Loss Application in Isolator Technology for Oncology Therapies]
    Speakers: Matthias Beck, PhD and Uwe Harenberg
    Speakers
    Sr Director Technology Center
    Fresenius Kabi USA, LLC
    Placeholder Person Graphic
    Process Engineering Manager
    Patheon
    Placeholder Person Graphic
    Manager New Business Development
    Oncotec Pharma Produktion GmbH
    Placeholder Person Graphic
    Managing Director
    GESA
  • 1215 - 1315
    Lunch in Expo Hall
  • 1315 - 1415
    Barrier Group Discussion
    Session Leaders
    Principal Process Engineer
    O'Neal Inc.
    Speakers
    Sr. Director, MP Expansion Project
    Fresenius Kabi USA LLC
    Senior Director, Operations
    Singota Solutions
    Director, Process Architecture
    IPS
  • 1315 - 1415
    Aseptic Group Discussions
    Session Leaders
    Senior Product Manager
    Robert Bosch Packaging Technology GmbH
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
  • 1315 - 1415
    Containment Group Discussions
    Session Leaders
    Head, Sales Containment
    SKAN AG
    Senior Pharmaceutical Engineering Specialist
    CRB
    Speakers
    Sr Director Technology Center
    Fresenius Kabi USA, LLC
    Head, Sales Containment
    SKAN AG
    Senior Pharmaceutical Engineering Specialist
    CRB
  • 1415 - 1445
    Barrier Report–Out
  • 1415 - 1445
    Aseptic Group Discussions Report-out
    Session Leaders
    Senior Product Manager
    Robert Bosch Packaging Technology GmbH
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
  • 1415 - 1445
    Containment Group Discussions Report-out
    Session Leaders
    Head, Sales Containment
    SKAN AG
    Senior Pharmaceutical Engineering Specialist
    CRB
  • 1445 - 1515
    Networking Break in Expo Hall
  • 1515 - 1700
    Regulatory Interactive Panel
    Session Leaders
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers
    Facility Reviewer
    FDA/CDER/OPQ/OPF/DIA
    Deputy Director, Science and Regulatory Policy
    FDA/CDER
    Placeholder Person Graphic
    Consumer Safety Officer
    FDA

IMIS Description Character Cleanup