Before the Event
17 March 2019
Day 1
18 March 2019
  • 0730 - 1830
    Registration Open
  • 0900 - 1015
    Plenary Session
    In this opening Keynote Session, Rick Friedman from FDA's Office of Manufacturing Quality shares his perspective of the state of aseptic processing, providing insights on the very latest findings and learnings.
    Session Leaders
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    [The State of Aseptic Processing: Current Findings and Learnings]
    Speaker: Richard Friedman
    || [Chesapeake Bay Area Chapter Introduction ]
    Speaker: Benjamin Skowronski
    || []
    Speaker: John Bournas
    Speakers
    Deputy Director, Science and Regulatory Policy
    FDA/CDER
    Business Development Director
    CRB
    President and CEO
    ISPE
  • 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
    Project Management Lead
    Jazz Pharmaceuticals, Inc.
    Principal Process Engineer
    O'Neal Inc.
    [A Harmonized Approach to an Environmental Monitoring Risk Assessment ]
    Speaker: Dawn Watson
    An industry collaboration comprising of 15 companies worked on the development of an easy to use standardized risk-based EM approach which improves the level of objectivity when identifying environmental monitoring locations in cleanrooms, conventional aseptic filling lines, RABS, and isolators. The approach will be described and recommendations will be provided for how the industry could adopt this approach to ensure that high standards for the design of a risk-based EM program are followed in a consistent manner. || [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
    Along with the incorporation of new technology, the facility of the future must also address the many other challenges faced by today’s facilities. This presentation will discuss how the struggles of today’s facilities inform the requirements for the facility of the future.
    Speakers
    Director, Manufacturing Microbial Control & Sterile Site Support
    Merck & Co Inc
    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
    Senior Product Manager
    Robert Bosch Packaging Technology GmbH
    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
    There are strict regulations and requirements to produce personalized medicines (ATMP) in terms of manufacturing, controls and compliance. Besides the continuous aseptic conditions during the process, the traceability of each individual batch or cell culture must also be ensured at any time by the technical design and process set-up of the facility. This presentation introduces the new manufacturing facility of CO.DON AG and shows how the requirements for equipment and control systems are met. || [Construction & Startup of Small Batch Manufacturing for Breakthrough Gene Therapy Product]
    Speaker: Greg R. Gara
    Addressing the decision to add manufacturing capacity and should one build or contract out which most scale start ups will face eventually. The ability to manufacturing capacity in record time from time of securing an existing structure to start of engineering lots. The gene and cell therapy sector of our industry is growing at a tremendous rate with new companies across the global looking bring their products to market. Many face the challenge to decide either to use contract manufacturers or to build our own manufacturing facility. This session will benefit the uncertainties of choosing to build. It will highlight a small scale gene therapy facility and present the key elements of the journey to build a plant from the ground up to meet aggressive timelines. || [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
    Vice President, Head of Global Manufacturing
    Codon AG
    Placeholder Person Graphic
    SGI Project Director
    Lonza
    Placeholder Person Graphic
    Vice President, Technical Operations & Engineering
    AveXis Inc
    Process Manager
    Integrated Project Services
    Global Sales Manager- Pharma & ATMP Division
    Comecer Group
  • 1100 - 1230
    Preventing Cross Contamination in Shared Equipment/Facilities I
    Regulatory and Occupational Safety as well as Cleaning and Cross Contamination requirements for aseptic toxic/high potent substances are covered during this session. Combined products like ADCs (Antibody Drug Conjugates) require PDE (Permitted Daily Exposure) of low nanograms per day level. This session will include strategies to avoid cross contamination in shared facilities and protect operators.
    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. || [GMP and Cleaning Requirements for Highly Potent Aseptic Products. New Annex 1 Impact ]
    Speaker: Richard Denk
    || [ADCs, High Potent Aseptic Filling]
    Speakers: Wolfgang Lau and Hartmut Schaz
    Speakers
    VP Global EHS
    Allergan Plc
    Head, Sales Containment
    SKAN AG
    Global Technology Partner
    NNE
    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: Fresenius-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
    Project Management Lead
    Jazz Pharmaceuticals, Inc.
    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 Study … Insights into state-of-the-art sterile fill finish applications for aseptic and high potent drugs]
    Speaker: Jürgen Michael Metzger
    The presentation will introduce state of the art Isolator equipment for aseptic and high potent drug manufacturing. Topics will include the main drivers for such a project, key considerations, line design, qualification measures, aseptic processing and long term experience in production. Attendees will benefit from insights in design concepts, sophisticated isolator equipment, selection process and advanced aseptic technology. || [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.
    Speakers
    Sr. Director, MP Expansion Project
    Fresenius Kabi USA LLC
    Barrier Systems & Process Specialist
    Robert Bosch Packaging Technology GmbH
    Manufacturing Technical Specialist
    Grand River Aseptic Manufacturing
  • 1330 - 1500
    Aseptic - Product Development and Disposables
    Hydrogen-Peroxide as a decontamination agent is widely utilized in the industry, but residues can have effects on products. This challenge has been studied in detail from a product development point of view and the results will be shared in this session. Cleaning validation is also an issue for disposables! This unusual thinking will be explored in a case study. Disposable equipment continues to revolutionize production, and great advancements continue in the field. Advances in fluoropolymer films help solve problems with leaking bags, while the material can be gamma-sterilized for the first time.
    Session Leaders
    Senior Product Manager
    Robert Bosch Packaging Technology GmbH
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    [Vapor Phase Hydrogen Peroxide (VHP) Sensitivity Determination for Protein Formulations]
    Speaker: Swapnil Pansare
    || [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. || [Advancements in Fluoropolymer Single Use Systems]
    Speaker: Eric Isberg
    Speakers
    Scientist - I, Process Engineering & Packaging
    MedImmune
    Product Manager, Single-Use Systems
    Robert Bosch Packaging Technology
    Director, Life Sciences
    Entegris
  • 1330 - 1500
    Preventing Cross Contamination in shared Equipment/ Facilities II
    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. This session will cover different case studies on high potent aseptic fill & finish. Modular and easy to change technologies from the view of a CMO will round out the session.
    Session Leaders
    Head, Sales Containment
    SKAN AG
    Senior Pharmaceutical Engineering Specialist
    CRB
    [Automated Cleaning of Parts in HPAPI 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
    Head of Marketing & Product Management
    Belimed AG
    Placeholder Person Graphic
    General Manager,Technology Development
    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 - the Perspective from Engineering Companies
    This industry panel discussion session begins with short, five-minute presentations from leading engineering companies followed by a moderated discussion. The discussion centers around lessons learned and the future outlook of robotics in aseptic manufacturing:
    -major installation projects
    -retrofitting of existing lines
    -possibilities and limits of the use of robots
    -robots versus simple automation
    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... || [Overview of Topics ]
    Speaker: Klaus Ullherr
    Speakers
    Global Aseptic Processing Subject Matter Expert
    PM Group
    Director, Process Technology / Associate
    IPS - Integrated Project Services, LLC
    Senior Product Manager
    Robert Bosch Packaging Technology GmbH
    President
    Genesis Engineers Inc
    Global Technology Partner
    NNE
    Senior Pharmaceutical Engineering Specialist
    CRB
  • 1715 - 1815
    Networking Reception in Expo Hall
Day 1 - Day 2
18 March - 19 March 2019
Day 2
19 March 2019
  • 0700 - 1700
    Registration Open
  • 0800 - 0900
    Annex 1 Hot Topics
    The European Medicines Agency (EMA) issued a draft version of Annex 1 for discussion in December 2017. As this guideline, once approved, applies to all manufacturing in Europe, as well as all PIC/S (Pharmaceutical Inspection Co-operation Scheme) countries and for all products imported to Europe, it has a huge impact on industry. ISPE, under Jean-Francois' leadership, submitted consolidated industry comments to EMA. In this breakfast session, the hot topics from the draft Annex 1 and their implications for industry will be discussed. Examples include: contamination control strategy, post-sterilisation-pre-use-integrity testing of sterilizing filters and H2O2 decontamination processes.
    Session Leaders
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    [Annex 1 Hot Topics: ISPE/Industry Thoughts ]
    Speaker: Jean-Francois Duliere
    Speakers
    Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate
    -
  • 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
    || [Transforming Aseptic Production Using Robotics: Equipment / Standardization / Technology / Robotics]
    Speaker: Elise Abinet PhD
    Speakers
    Regional Sites Coordinator for China and Korea
    Bayer AG
    Global Technical Manager
    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
    Project Management Lead
    Jazz Pharmaceuticals, Inc.
    Principal Process Engineer
    O'Neal Inc.
    [Technical and Component Considerations for Achieving High Dose Accuracy]
    Speakers: Marc Engel & Alexander Haig
    The auto-injection device market is driving higher accuracy and tighter filling specifications for dose accuracy. Catalent Biologics has been working with clients to optimize fill accuracy for high value and personalized medicine, and has studied how controllable variables such as machine capabilities, process parameters, and dosing path configurations can be optimized to compensate for the uncontrollable challenges caused by product characteristics and component specifications. In this presentation, we will share case studies of how we optimized the filling process for unique product characteristics, such as viscosity or crystallization. We will review our specialized product development approach to 6-sigma filling, and share challenges and lessons-learned from the Catalent Biologics facility in Bloomington, Indiana. || [Critical Evaluation of Functional Principles in H2O2 Bio-Decontamination of Barrier Systems: The Next Evolutionary Step]
    Speaker: Dena Flamm & Andreas Schachtschneider
    To perform aseptic processes within barrier systems, beforehand bio-decontamination of the surfaces present is indispensable. Thereby the number of reproducible microorganisms (colony forming units) is reduced to a certain level. It is common state-of-the-art to use hydrogen peroxide as biocidal agent by applying different approaches for distribution of the compound in the barrier system. However, homogenous exposure of the surfaces towards an adequate amount of H2O2 remains a challenge.
    In this presentation it will be discussed which physical principles were used until today, as well as the application of atomization-driven evaporation of H2O2 as a new approach will be explained and evaluated. Therefore, a closer insight on the distribution of H2O2 in an isolator and the coverage of surfaces will be given for the different principles. Comprehensive experimental data is the basis for the closer explanation and evaluation of the atomization-driven evaporation of H2O2. A comparison with the well-established processes completes the discussion.
    A faster and more effective distribution of H2O2 is achieved with the presented system compared to the currently applied evaporation processes. This results in faster decontamination cycle times, lower stress on materials or products and reduced outgassing effects. Thus, the atomization-driven evaporation of H2O2 is a promising alternative to the existing systems and can be regarded as the next evolutionary step in bio-decontamination of barrier systems. || [First Licensed VANRX Robotic Gloveless Filling Machine]
    Speakers: Brent Lieffers and Christa Myers
    Speakers
    Head R&D Biodecontamination
    METALL+PLASTIC GmbH / OPTIMA Pharma
    Senior Process Engineer
    Catalent Biologics
    Business Development Manager
    Optima Machinery Corporation
    Senior Director, Operations
    Singota Solutions
    Sr. Director of Facilities and Engineering
    Catalent Biologics
  • 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: Dan Kostov, 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) for Viable Particles ]
    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
    Research Professor, Technology Research
    University of Maryland Baltimore County
    Executive Vice President
    BioVigilant
    President & CEO
    RPA Engineering
    CEO
    Airex Co., Ltd.
  • 1045 - 1215
    Preventing Cross Contamination in shared Equipment/ Facilities III
    High Potent/Toxic aseptic processing and facility design is a very complex interaction between the equipment, room, airlocks, utilities, cleaning and waste handling. During this session Automated Solutions, Isolator Technology, and design challenges for a new oncology products facility will be presented.
    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
    The goal of this presentation is to provide criteria and information on current and latest Fill-and Finish concepts for a high potent aseptic facility to help aseptic manufacturers build the facility and implement the right engineering measures resulting in a safe and reliable manufacturing facility while ensuring patient safety. || [Flexible Zero Loss Application in Isolator Technology for Oncology Therapies]
    Speakers: Matthias Beck, PhD and Uwe Harenberg, PE
    The presented filling lines have the capabilities for the fill & finish of small molecule APIs and large molecule APIs, like antibodies and ADCs.We have invested in most flexible compounding & formulation systems as well as in robotic driven filling lines including freeze-dryer in Isolator technology, designed as a zero-loss-system, covering the vial- sizes 2 to 200 mL. The lecture covers: Easy & safe connection of multiple compounding systems at a filling line, Small scale filling line equipped with a pilot scale freeze dryer, Robotic driven filling- line equipped to change vials sizes without opening the isolator, Isolator concept class “A” in class “D” fulfilling EU- & FDA- requirements, Optimized design of in- & outlets of isolators for continuous processes, Worst case & monitoring – how to minimize the risks, Experiences from several years of working with isolators.
    Speakers
    Sr Director Technology Center
    Fresenius Kabi USA, LLC
    Manager New Business Development
    Oncotec Pharma Produktion GmbH
    Managing Director
    GESA
  • 1215 - 1315
    Lunch in Expo Hall
  • 1315 - 1415
    Barrier Group Discussion
    Meet and network with experts and industry colleagues to discuss topics of interest in barrier and isolator technology. This interactive session provides the opportunity to discuss specific questions in detail in small groups. Topics include upgrading legacy facilities, facilities of the future, and gloveless filling isolators.
    Session Leaders
    Project Management Lead
    Jazz Pharmaceuticals, Inc.
    Principal Process Engineer
    O'Neal Inc.
    [Upgrading Legacy Facilities]
    Group Leader: Jean Allaume
    || [Gloveless Filling Isolators]
    Group Leader: Brent Lieffers
    || [Facilities of the Future]
    Group Leader: Jason Collins
    Speakers
    Sr. Director, MP Expansion Project
    Fresenius Kabi USA LLC
    Senior Director, Operations
    Singota Solutions
    Director, Process Architecture
    IPS
  • 1315 - 1415
    Aseptic Group Discussions
    Meet and network with experts and industry colleagues to discuss topics of interest in aseptic manufacturing. This interactive session provides the opportunity to discuss specific questions in detail in small groups. Topics include robotics, disposables, and cell and gene therapy
    Session Leaders
    Senior Product Manager
    Robert Bosch Packaging Technology GmbH
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    [Gene and Cell Therapy]
    Group Leader: Massimiliano Cesarini
    Speakers
    Global Sales Manager- Pharma & ATMP Division
    Comecer Group
  • 1315 - 1415
    Containment Group Discussions
    Meet and network with experts and industry colleagues to discuss topics of interest in containment and potent product manufacturing. This interactive session provides the opportunity to discuss specific questions in detail in small groups. Topics include Annex 1 impact on potent products, cleaning and cross contamination, and design of high potent filling lines.
    Session Leaders
    Head, Sales Containment
    SKAN AG
    Senior Pharmaceutical Engineering Specialist
    CRB
    [Design of High Potent Filling Line]
    Group Leader: Christian Mrotzek
    || [Impact New Draft Annex 1 on High Potent Product]
    Group Leader: Richard Denk
    || [Cleaning and Cross Contamination]
    Group Leader: Christa Myers
    Speakers
    Sr Director Technology Center
    Fresenius Kabi USA, LLC
    Head, Sales Containment
    SKAN AG
    Senior Pharmaceutical Engineering Specialist
    CRB
  • 1415 - 1445
    Barrier Group Report-Out
    Learn from your peers and colleagues. This session provides the opportunity to share salient and thought-provoking ideas generated from each small discussion group.
    Session Leaders
    Project Management Lead
    Jazz Pharmaceuticals, Inc.
    Principal Process Engineer
    O'Neal Inc.
  • 1415 - 1445
    Aseptic Group Report-out
    Learn from your peers and colleagues. This session provides the opportunity to share salient and thought-provoking ideas generated from each small discussion group.
    Session Leaders
    Senior Product Manager
    Robert Bosch Packaging Technology GmbH
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
  • 1415 - 1445
    Containment Group Report-out
    Learn from your peers and colleagues. This session provides the opportunity to share salient and thought-provoking ideas generated from each small discussion group.
    Session Leaders
    Head, Sales Containment
    SKAN AG
    Senior Pharmaceutical Engineering Specialist
    CRB
  • 1445 - 1515
    Networking Break in Expo Hall
  • 1515 - 1700
    Interactive Regulatory Panel
    This is your opportunity to pose your most pressing quality and regulatory questions directly to a panel of respected FDA thought leaders in the aseptic processing space. This moderated and interactive discussion continues to be a much-anticipated and highly rated session for this conference and is always informative; providing insights exclusive to conference attendees.
    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
    Director, Div. Case Management
    FDA/CBER/OMPT/OCBQ
    Placeholder Person Graphic
    Consumer Safety Officer
    FDA
    Deputy Director (Acting), Office of Process and Facilities
    FDA/OPF

Speaker Qualifications

Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.

IMIS Description Character Cleanup