Before the Event
Sunday, 1 March 2020
Day 1
Monday, 2 March 2020
  • 0730 - 1800
    Registration Open
  • 0900 - 1000
    Opening Plenary Session
    It is a tradition that the Aseptic Conference is opened with a keynote presentation by a health authority representative. In 2020, the FDA has been invited to discuss current expectations of the Food and Drug Administration for sterile products and processes. This will include recent findings from field inspections the world over.
    Session Leaders
    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers
    Associate/Core Team Leader
    CRB
    Director, Office of Pharmaceutical Quality Operations
    FDA/ORA
    Interim CEO & President
    ISPE
    Presentation Information
    [Chesapeake Bay Area Chapter Welcome]
    Speaker: Ben Skowronski
    || [Current Regulatory Perspectives on Aseptic Processing]
    Speaker: Alonza Cruse
    || [Welcome]
    Speaker: Tim Howard
  • 1000 - 1530
    Exhibit Hall Open
  • 1045 - 1215
    Alternate Technologies: Options for Decontamination of Tubs, Nests, and Other Prepared Components
    This session will focus on a range of technologies available to effectively introduce tubs, nested components, and other pre-packaged containers. Three different equipment manufacturers will present their full option portfolio to fit any project budget; you can expect to see technology solutions from $250,000 to over $2MM.
    Session Leaders
    AVP, Xeno and Regenerative Medicine Operations
    United Therapeutics Corp.
    Speakers
    CEO
    Claranor SA
    Executive Vice President
    Bausch Advanced Technologies Inc
    Vice President, Technology & Business Development
    Skan US
    Presentation Information
    [Robotic Tub Decontamination System with Pulsed Light]
    Speaker: Christohe Riedel
    This presentation will explain the need for new inline tub decontamination systems, as well as introduce the pulsed light technology, its actual use for packaging decontamination in other industries, and the idea of applying this principle to tub decontamination. This presentation will then focus on the validation procedure, reference micro-organism, inoculation technique, BI development, and conclude to the features and integration of the Robotic Tub Decontamination System in an aseptic line.>br/> || [Pulsed UV Decontamination Case Study]
    Speaker: Eugen Goidenko
    Pulsed Ultra Violet Light for Surface Decontamination: A fast, reliable and effective tool for the pharma industry.
    || [Key Decision Criteria for Transfer Technology Selection of NTT, E-Beam, H2O2 or UV-C Decon]
    Speaker: Leslie Edwards
    The selection of an appropriate transfer method into an isolator is quality, manufacturing and financial decision. This presentation will provide a brief overview of commonly used technologies and review technical, quality and cost factors in selecting teh appropriate solution.
  • 1045 - 1215
    ATMPs: Viral Vectors, CAR-T, and Production Approaches
    Advanced Therapeutic Medicinal Products, ATMPs, are a recent innovation in the industry and provide some interesting challenges: individualized/personalized medicines mean smallest batch sizes, down to single units. Keeping the high standards of aseptic operations currently established, including quality testing require new concepts in building fill-finish operations. Additional challenges are presented in that these products are often live-cell-based or are formulated in live-virus vector-systems. This session will present three case studies on the topic.
    Session Leaders
    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers
    Principal Engineer
    Project Farma
    Vice President of Manufacturing
    Kite Pharma, Inc.
    Director, Oxbox & Fill Finish Operations
    Oxford BioMedica
    Senior Associate, Biotech Market Leader
    CRB
    Vice President, Commercial Manufacturing
    Iovance Biotherapeutics, Inc.
    Head of PHSS Aseptic Processing and Containment Special Interest Group
    F. Ziel GmbH
    Director of Process Simulation
    CRB
    Presentation Information
    [The Impact of Innovation on Building the Facilities of the Future]
    Speakers: Christopher McDonald and John Khoury
    This presentation will discuss utilization of new technologies and techniques in the cell therapy field to forge the path for the next generation of biopharmaceutical manufacturing. Presenters will discuss the challenges of building a modern cell therapy facility while undergoing constant change. Adaptability, flexibility, and ingenuity are the cornerstones necessary to cross over the challenges that an innovative facility will inevitably face.
    || [Oxford Biomedica UK Integrated Aseptic Processing Platform For Multiple ATMP Indications Including A Case Study On A Viral Vector Used In CAR-T Cell Cancer Therapy]
    Speakers: Melanie Bull and James Drinkwater
    ATMPs require new and innovative process solutions based on Aseptic processing that follow QRM principles when adapting generic GMP. The new OXBOX facility at Oxford BioMedica includes an integrated formulation and filling platform, primarily based on single use systems, pre-sterilised containers/ closures and automated vial filling, provided by partner Flexicon Watson Marlow and barrier technology with integrated vH202 decontamination provided by partner F Ziel GmbH.
    Formulation and vial filling is on a flexible combined platform that is suitable for a ‘scale out’ approach so with increasing demands different ATMP indicators can be processed. Where there are limitations in ATMP process time because of ‘Thaw-Freeze’ process windows efficiency is achieved by process integration and minimised in-process transfers across different zone grades. Aseptic containment plays a role in the OXBOX process design to process different products where cross contamination control is critical. This presentation covers a learning and key decisions made, via a case study, of developing a multi-indication ATMP process platform with focus on one application of processing a lentiviral vector produced as single source by Oxford Biomedica (OXB) for their collaborator Novartis and used in the CAR-T cell therapy Kymriah®.
    || [Planning for The Unknown – Autologous Cell Therapy Scale Out Planning ]
    Speakers: Sumit Verma, Ryan McDonough, and Philip Lyman
    Autologous cell therapies have the potential to cure diseases rather than just manage them. They are expected to grow sharply over the next decade. Results from the clinic are impressive and commercial launches have shown that companies can tackle the manufacturing hurdles, however, there is no playbook. The industry and technology are changing rapidly and planning for a facility today that can withstand the upcoming changes is challenging. This session will focus on leveraging key partnerships, well defined user requirements, and data driven selection criteria to enable site selection and facility planning that will withstand the test of time. Logistics play a critical role in autologous cell therapy facility selection and facility design – overcoming challenges associated with scale out versus scale up, utilizing discrete event simulation modeling and a carefully tiered phased design and construction approach will be discussed.
  • 1045 - 1215
    Case Studies Part 1 Deep Dive - Process Science and Technology, High Potent Products, GMP, and Occupational Safety
    This session gets in detail of fill and finish operations. What are the challenges for an CMO's to design a facility for the use of multi-product? Another topic about Containment requirements for aseptic toxic/high potent substances.
    Both Case Studies will provide a deeper dive into project execution.
    Session Leaders
    Senior Consultant, Aseptic Processing & Containment
    SKAN AG
    Speakers
    Project Engineer
    Fresenius Kabi
    Manager of MSAT (Manager of Manufacturing Science and Technology)
    Grand River Aseptic Manufacturing
    Presentation Information
    [Challenged during Design Phase to Cover all aspects from GMP to Occupational Safety]
    Speaker: Amir Zandnia
    The goal of this presentation is to provide criteria and information on current and latest Fill-and Finish Designs 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. A case study will be presented regarding the challenges that exist in design of such facilities and how to categorize and solve the challenges on risked base approach. || [Developing a CMO Multi-Product Aseptic Fill & Finish Facility to Meet the Customer Requirements]
    Speaker: Ryan Waldhart
    The presentation will provide insight into the building of a new green field, multi-product, aseptic fill project. The new facility contains state of the art processing equipment for filling, lyophilization, and utilizes isolator technology. Topics will include developing a CMO multi-product aseptic fill facility, best practices for product containment, current project status, and future project 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 multi-product CMO facility.
  • 1315 - 1445
    Practical Approaches to Implementing Barriers - Case Studies
    Today's ever tightening regulatory environment is pressing drug product manufacturers to explore and implement barrier technology into their designs. Manufacturers are left to determine which sciences/equipment are appropriate and least cumbersome for the application. This program track will focus on the why's, how's, and challenges that three manufacturers encountered during their facility design or expansion processes. Each presentation will walk you through the thought processes and lessons learned from their facility plans.
    Session Leaders
    Director of Operations, Midwest Region
    CAI
    Speakers
    Founder & CEO
    Bryllan LLC
    Sr. Director Technology Center
    Fresenius Kabi USA, LLC
    Capital Project Manager
    Seqirus
    President
    Jerrod Shook Pharma Consulting Ltd., LLC
    Presentation Information
    [A Paradigm Shift in Aseptic Filling Operations: The Benefits and Challenges]
    Speaker: Douglas Bryans
    As complexity increases in product development and demand change on fill/finish capacity, Bryllan offers one approach to provide flexible filling of different presentations, batch sizes and classes of drug products in response to this demand.
    || [Process Innovation – A Case Study in Implementing Modern Technologies Globally]
    Speaker: Christian Mrotzek
    This presentation will give insights regarding our modernization project in Melrose Park, Illinois which could help aseptic manufacturers to design flexible and reliable aseptic manufacturing processes for a multi-product facility. A focus will be given on containments in various process steps (formulation, filling and lyophilization). The case study will address the challenges that exists when implementing process innovations in those areas. Further critical success factors will be given to execute successfully similar projects globally.
    || [High-Speed Syringe Filling Expansion at Seqirus – Case Study]
    Speaker: Jerrod Shook and Thomas Plante
  • 1315 - 1445
    Robotics in Clean Room Applications: Lessons Learned and Novel Uses
    Robots for transfers have been used for several years in aseptic fill-finish operations, but with the recent advancements in the technology, the applications go beyond pure transfers and explore tasks like robotized environmental monitoring and other new, innovative uses. Some automated lines in isolators go so far as eliminating the gloves, so the process needs to be even smoother as no interventions are possible. Three case studies will be presented on the use of robots in clean-rooms, a topic that will again be picked up in the panel-discussion.
    Session Leaders
    Senior Product Manager
    Syntegon Technology, Formerly Bosch Packaging Technology
    Speakers
    PTI-T Global Technical Lead Large Molecules
    F. Hoffmann-La Roche Ltd
    Life Sciences Technologist
    CRB USA
    Director, Aseptic Processing
    Johnson & Johnson
    Director Drug Product Clinical Supply Chain
    Janssen Pharmaceuticals Schaffhausen
    Business Development Manager
    Pharma-Integration
    Presentation Information
    [Roche’s Approach in Tailoring the DP Facility of the Future ]
    Speaker: Markus Stuebchen
    Facing a changing portfolio, Roche is transforming manufacturing operations to meet future challenges in terms of smaller batch sizes, higher efficiency, reducing cost, avoiding human error, increasing flexibility in manufacturing and reducing tech transfer efforts in order to deliver high value products to the market in a sustainable, agile and high-quality manner.
    An essential part of these efforts is the approach of network-wide implementation strategies and the deployment of highly automated and robotic systems reducing human interventions in controlled environments. Most of the time, such new technologies trigger paradigm-shifts that impact traditional ways of manufacturing and force a lot of re-working and challenging of established processes and also require regulators to rethink how to assess. This presentation gives an overview about ongoing Roche/Genentech-initiatives that leverage the approach to design the appropriate facility of the future.
    || [Robotics & Automation: Understanding the Basics]
    Speaker: Carmine Stropoli
    This session will present an overview of Robotics and Automation Technologies and examples of current applications in pharma facilities. Various types of available robotics will be described including an application spectrum and criteria “scorecard” that are used to support identifying potential applications in a facility. A reference guide to support determining the applicability of a manual, collaborative or fully automated robotic operation based on the degree of desired operational flexibility, consistency of items, predictability of presentation and run volumes will be illustrated. “Key” robotic terminologies and ISO standards for robotic systems that provide the basis for preparing a URS for a robotic application will be reviewed. Considerations for operations to incrementally implement robotic work cells that may eventually interface with automated load transferring devices will be described and illustrated.
    || [Microbiological Quality Assurance Strategy for Robotized Aseptic Filling with No Human Intervention]
    Speakers: Dieter Bachmann and Thomas Thurn
    Advanced robotics technologies enable a new way of aseptic processing by eliminating existing challenges in conventional filling processes and provide readiness for new modalities and personalized medicines. The “Pharma Integration” Aseptic Smart Filling Line at the Janssen Pilot Plant allows in this respect for a new way of working in aseptic core without requirement of human intervention. These allows to design a new microbiological control & sterility assurance strategy for aseptic processing by taking the new technologies with integration of isolator and process in one unit and the ready to use approach in primary packaging into account. With this new modular robotics line the readiness for real time release and scale out manufacturing approaches can be defined.
  • 1315 - 1445
    Case Studies Part 2 - Flexible Fill & Finish, Validation of a Modular System, and Sterile API Manufacturing
    This session covers different case studies where modularity is the key. The new developments in Biopharmaceuticals moves in the direction of small batches, personalized medicine and high potent/toxic substances. More than 700 Bio- Pharmaceutical products are in pre-clinical and clinical trials which are considered as high potent/toxic. This require for the future a different design for the aseptic fill and finish operations. Two case studies will cover exactly this topic. Another case study will focus on another new trend of aseptic powder API`s produced and filled as powders in containers like Vials.
    Session Leaders
    Pharmaceutical Market Director
    CRB
    Speakers
    Director, Process Development
    Amgen
    Sr. Manager, Process Engineering
    Evonik Corporation
    Senior Director Validation
    Gilead Sciences Inc
    Presentation Information
    [Innovations in Aseptic Processing – Opportunities and Challenges in Implementing Next Generation Technologies ]
    Speaker: Chakradhar Padala
    In recent years, emergence of new product modalities is driving the need for high mix low volume, flexible manufacturing solutions. Multiple enabling technologies that can provide flexibility, speed to build, qualify and validate new manufacturing facilities are emerging to meet this need. In this presentation, new emerging trends impacting the aseptic drug product manufacturing process will be discussed, and we will share a playbook approach to compare different flexible fillers on operational, economic and strategic fronts. Lastly, a case study on our experience with novel gloveless isolator based aseptic filler, and characterization data to mitigate some of the potential risks will also be shared.
    || [Evonik’s VarioSys Filling Line Capabilities] Pharmaceutical companies are increasingly outsourcing to contract development and manufacturing organizations (CDMOs) due to the benefits and competitive advantage CDMOs can bring to their business. Evonik is one of the world’s leading CDMOs selected by pharmaceutical companies to help transform their APIs into complex parenteral drug products. Our CDMO portfolio of drug delivery systems comprises more than six established formulation technologies including lipid nanoparticles (LNPs), polymeric microparticles, nanoparticles, micelles, drug-loaded implants. Due to the extended portfolio of product and services available at Evonik, flexibility in equipment and operations is important. Evonik’s presentation highlights its capabilities and discusses how the VarioSys® filling line offers the flexibility required to conduct aseptic fill/ finish operations.
    || [Validation of Exchangeable Modules]
    Speaker: Bernard Shamsai
    The use of ready-to-use glass components has enabled development of flexible filling equipment. Filling lines with exchangeable modules provide operational flexibility by reducing capital, space and timelines required to qualify and operate the systems. This case study covers general validation strategy applied to flexible filling line when modified from vial filling to syringe filling configuration. The idea of initial qualifications and supplemental qualifications applied to an isolator-based filling system will be discussed.
  • 1530 - 1700
    Industry Panel: Automated Visual Inspections: Where are we headed?
    Hear from equipment manufacturers regarding the current status and exciting new concepts being used in visual inspections in the pharmaceutical industry, including robotics. Artificial intelligence, machine learning, deep learning, and interconnected workstations are all being integrated into new installations, but most companies are still relying on the Knapp-test that ties AVI results back to inspection by humans. Attendees will benefit from their lessons learned from product specific qualifications.
    Session Leaders
    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers
    Head of Research, Development and Laboratory Services
    Wilco AG
    Senior Manager, Vision Technology
    Syntegon Technology, Formerly Bosch Packaging Technology
    Pharma Inspection Product Development
    Stevanato Group Spa
    USA Sales Manager
    Brevetti C.E.A.
    Presentation Information
    [ATS Automation]
    Speaker: Steve Wardell
  • 1700 - 1800
    Networking Reception in Exhibit Hall
Day 2
Tuesday, 3 March 2020
  • 0700 - 1700
    Registration Open
  • 0800 - 0900
    Women in Pharma® is pleased to host this important technical session sponsored by CRB. Hear from a panel of experienced leaders in Barrier and Aseptic technologies, who will share recent survey insights on the implementation of isolator and fill-lines being installed around the globe. The updated survey was based on the well-remember RABS/Isolator survey conducted and presented by Jack Lysfjord at previous Aseptic conferences.

    Women in Pharma Mission:
    ISPE Women in Pharma® (WIP) provides women in the pharmaceutical industry a forum for connecting and collaborating on technical and career advancement topics. WIP's inclusive community leverages a network of mentors, role models, and resources across all levels to foster balanced professional success. Recognizing women that make efforts to lead, coordinate, and present technical presentations that are inclusive of both women and men is a key element in the success of the industry.
    Session Leaders
    Pharmaceutical Market Director
    CRB
    Speakers
    Director, Aseptic Technology
    CRB
    Director, Process Technology / Associate
    IPS - Integrated Project Services, LLC
    Presentation Information
    [ISPE Barrier Survey Data and Trends]
    Speaker: Lisa Dorn, Jessica Frantz & Paul Valerio
    What are the latest trends in aseptic filling? What barrier systems have been installed throughout the industry in the past 5 years? Isolators, RABS? Is the industry trending toward single use and ready to use? What product categories are intended to run on new filling lines? Preview how the industry responding to robotics, automated lyo loading, gloveless isolators. If you are interested in the results of data collected across the industry, come and hear how ISPE has initiated the latest barrier survey and preliminary results.
  • 0915 - 1000
    Plenary Session: How Perspectives Change: From Regulator to Regulated
    A long career in FDA provides a person with great insight into the mindset of a Regulator. The transition to industry does bring those insights into sharper focus. Whether the topic relates to reviews or inspections, there is an effort on the part of companies to understand the intent behind the regulators' words and actions. There is a bit of mystique surrounding this de-encryption process. The speaker will attempt to clarify the intention behind some of the words and actions of the regulators. Practical examples of situations requiring interpretation will be provided.
    Session Leaders
    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers
    Compliance Head for Biologics Quality Operations
    Sanofi
    Presentation Information
    [How Perspectives Change: From Regulator to Regulated]
    Speaker: David Doleski
    A long career in FDA provides a person with great insight into the mindset of a Regulator. The transition to industry does bring those insights into sharper focus. Whether the topic relates to reviews or inspections, there is an effort on the part of companies to understand the intent behind the regulators' words and actions. There is a bit of mystique surrounding this de-encryption process. The speaker will attempt to clarify the intention behind some of the words and actions of the regulators. Practical examples of situations requiring interpretation will be provided.
  • 1000 - 1515
    Exhibit Hall Open
  • 1045 - 1215
    Materials Transfer, Disposable Technology - Implementation, Risk Management and Testing Methods
    Single-use technologies are revolutionizing manufacturing techniques for product transfers into barrier systems. This session will explore some of the latest options available to manufactures. With these new options available, new risks must be analyzed from a sterility assurance standpoint. Extractable/ leachable testing methodologies for SUS technologies will also be analyzed.
    Session Leaders
    AVP, Xeno and Regenerative Medicine Operations
    United Therapeutics Corp.
    Speakers
    Principle Scientist, Parenteral MS&T
    Bristol-Myers Squibb
    Product Manager, Primary Packaging for Pharma Liequid Packaging, NA
    Syntegon Pharma Technology
    Director, Microbial Control
    Merck & Co.
    Presentation Information
    [Technical Considerations for Usage of Single-Use Assemblies for Drug Product Manufacturing ]
    Speaker: Swapnil Pansare
    Single-use assemblies (SUA) are becoming important part of Drug Product (DP) manufacturing mainly due to reduced risk of cross contamination & rapid implementation & fast turnaround time between the batches. However, single use assemblies has its unique challenges including extractable and leachable assessment requirement, evaluation of compatibility of SUA with Drug Product & SUA design considerations for robust DP manufacturing. This presentation will discuss technical considerations for design of SUA for various unit operations of DP manufacturing process including Drug Substance (DS) pooling & mixing, hold, filtration and filling steps. Also, a case study will be presented on potential challenges for use of SUA in DP manufacturing. As part of the case study, summary of particle issue observed for using SUA during commercial DP manufacturing will be discussed. Approaches used for mitigation of particles for SUA and lessons learnt from the investigation will also be shared during this talk.
    || [Adapting to Standardization of Extractables Testing for Single-Use Components ]
    Speaker: Laura Moody
    As integral contributors within the pharmaceutical supply chain, single-use component suppliers have been required to provide extractables data for their products. As the adoption of the standardized extractables testing protocol by the BioPhorum Operations Group (BPOG) as well as draft chapter USP has grown, it has provided much needed guidance for single-use technology end users and suppliers alike. This presentation will address how single-use component manufacturers are adapting their legacy extractables testing to encompass the broader scope of solvents and time points included in the standardized protocols as well as the broader implications for stakeholders. A case study comparing extractables data generated from legacy testing to data gathered through use of the standardized BPOG protocol for single-use filling needles will be presented.
    || [Can Sterile Connections Be Made Anywhere?]
    Speaker: Dawn Watson
    Technologies including sterile connectors and tube welding are widely used throughout the pharmaceutical industry and enable closed system processing while eliminating impact from the surrounding environment. Validation of these technologies typically involves worst case conditions and includes, but is not limited to a microbial challenge, physical integrity test(s) and demonstration in Process Simulations. The successful validation of these technologies verifies that these systems are robust and reliable in maintaining a sterile pathway during the connection process. While validation confirms that these technologies are capable of being robust, training and qualification of operators are key to ensure that these technologies are utilized as intended and with limited risk of failure. This presentation will provide an overview of the considerations that should be evaluated when employing the use of these technologies. It will review the various risk factors associated with these technologies, how they should be evaluated when determining the environment that they will be used in and how to develop the appropriate control strategies to prevent potential failure modes.
  • 1045 - 1215
    Small Scale/Clinical Manufacturing: How to Produce Small Lots Effectively
    Small scale and clinical manufacturing have different requirements than full-scale, commercial manufacturing, but needs to fulfill the same standards concerning aseptic handling. A prime example of this are the compounding pharmacies, academic institutions and hospitals. This session will look more closely at the challenges faced for these operators and will explore the solutions that they found.
    Session Leaders
    Senior Product Manager
    Syntegon Technology, Formerly Bosch Packaging Technology
    Speakers
    Associate Director, Drug Product Operations
    Teva Pharmaceuticals - West Chester, PA
    Assistant Director, Global C&Q
    CAI
    Senior GMP Quality Expert
    FDAzilla
    Director Business Development, UIP
    University of Iowa Pharmaceuticals
    Presentation Information
    [Case Study: Small Flex Filler Using Single Use Technologies]
    Speaker: Andy Halsey
    A case study for implementation of a small flexible filler using single use technologies will be presented. The focus of the presentation will be on the transition from validation into clinical production from the owner’s perspective, including use of risk assessment strategies, technical challenges overcome, integration of multiple vendor technologies, and some key lessons learned.
    || [The Trials and Tribulations of Becoming a Sterile 503B Outsourcing Facility ]
    Speakers: Jerry Chapman and Jason McGuire
    FDA’s recent creation of the 503B compounding outsourcing facility has led many pharmacies to declare themselves a 503B facility, which can be a lucrative space to be in. However, as evidenced by the number of FDA 483s and warning letters, many are finding the transition challenging. This presentation will review the expectations that come with the 503B designation, including the need to follow Good Manufacturing Practices, which mandates a separate quality unit and specific requirements to be discussed during the session.
    || [U of Iowa Pharmaceuticals - Innovative Facility/Process Design and Delivery]
    Speakers: Randy Yeates and William Bennett
    Using innovative facility and process design to meet unique business needs and niche customer demands, and a risk-based approach to deliver commissioning and qualification: first the new facility must be flexible enough to support many customers and products while still maintaining full cGMP compliance. Second, the facility must be designed to handle phase I/II clinical to small-volume commercial batch size. Third, the new facility must be state-of-the-art including isolator-based, fully automated filling, vial processing, and lyophilizer loading. Fourth, the new facility must be qualified in a science-based, risk-based, cost-effective, schedule-sensitive manner.
  • 1045 - 1215
    Science & Technology - Glove Management, Robust Short Decontamination Cycles
    This new session will introduce new scientific work on Aseptic Processing. Safe Aseptic Processing is the result of scientific work provided from many specialists around the world. This new session shall give them the chance to introduce their work to a wider audience. Two important topics will cover the session. Gloves and their use in Barrier System based on Quality Risk Management and Fast Surface Decontamination with Hydrogen Peroxide and low residue levels afterwards.
    Session Leaders
    Senior Consultant, Aseptic Processing & Containment
    SKAN AG
    Speakers
    R&D Project Manager
    Skan AG
    Senior PET Engineer
    AstraZeneca
    Presentation Information
    [Latest Trends in H2O2 Decontamination Technology: Robust Short Cycles with Low H2O2 Residues]
    Speaker: Martin Novak
    The presentation brings an overview of H2O2 decontamination technology used in pharmaceutical isolators, its evolution and insight into key design decisions and applied process control strategy.
    || [Isolator Glove Management: Evaluation of Regulatory Guidance And Framework of Recommendations]
    Speaker: Jesse Dill
    Overview of the BPOG Isolator Glove Management paper. This paper is a best practice guide to management of Isolator gloves for production isolators.
  • 1315 - 1415
    Barrier Group Discussions
    Get in Contact with the experts and use the opportunity to discuss different topics in a small group with other attendees. This session is every year one of the highlights on the second day with a lot of knowledge exchanges and many times important questions are discussed and solved. Get ready and bring your questions to the breakout session.
    Session Leaders
    AVP, Xeno and Regenerative Medicine Operations
    United Therapeutics Corp.
    Speakers
    Director of Operations, Midwest Region
    CAI
    AVP, Xeno and Regenerative Medicine Operations
    United Therapeutics Corp.
    Vice President, Technology & Business Development
    Skan US
    Presentation Information
    [Group Topic: Review of Case Studies – What did we learn, what remains unanswered?]
    Group Leader: Keith Weseli
    || [Group Topic: SUS Components in Aseptic Processing – Further Discussion]
    Group Leader: Matathew VonEsch
    || [Group Topic: Crossing the Barrier – Use of SUS in Barriers]
    Group Leader: Les Edwards
  • 1315 - 1415
    Aseptic Group Discussions
    Get in Contact with the experts and use the opportunity to discuss different topics in a small group with other attendees. This session is every year one of the highlights on the second day with a lot of knowledge exchanges and many times important questions are discussed and solved. Get ready and bring your questions to the breakout session.
    Session Leaders
    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers
    Life Sciences Technologist
    CRB USA
    Senior Product Manager
    Syntegon Technology, Formerly Bosch Packaging Technology
    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Presentation Information
    [Group Topic: Robotics]
    Group Leader: Carmine Stropoli
    || [Group Topic: Small Scale/Clinical Batch Production]
    Group Leader: Klaus Ullherr
    || [Group Topic: Cell & Gene Therapy ]
    Group Leader: Jörg Zimmermann
  • 1315 - 1415
    Containment Group Discussions
    Get in Contact with the experts and use the opportunity to discuss different topics in a small group with other attendees. This session is every year one of the highlights on the second day with a lot of knowledge exchanges and many times important questions are discussed and solved. Get ready and bring your questions to the breakout session.
    Session Leaders
    Senior Consultant, Aseptic Processing & Containment
    SKAN AG
    Speakers
    R&D Project Manager
    Skan AG
    Senior Consultant, Aseptic Processing & Containment
    SKAN AG
    Pharmaceutical Market Director
    CRB
    Presentation Information
    [Group Topic: Surface Decontamination with H2O2]
    Group Leader: Martin Novak
    || [Group Topic: Preventing Cross Contamination]
    Group Leader: Richard Denk
    || [Group Topic: Facility Design for Highly Potent Products]
    Group Leader: Christa Myers
  • 1415 - 1445
    Barrier Group Discussions 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
    Director of Operations, Midwest Region
    CAI
  • 1415 - 1445
    Aseptic Group Discussions 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
    Syntegon Technology, Formerly Bosch Packaging Technology
  • 1415 - 1445
    Containment Group Discussions 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
    Pharmaceutical Market Director
    CRB
  • 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, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers
    Chemist, Review Branch 1
    FDA
    Facility Inspection and CMC Review Branch 2
    US FDA
    Deputy Director, Science and Regulatory Policy
    FDA/CDER
    Director (Acting), Office of Pharmaceutical Manufacturing Assessment
    FDA/CDER/OPQ/OPF
    Director, Div. Case Management
    FDA/CBER/OMPT/OCBQ
    Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality
    FDA/CDER/OC/OMQ
    Director, Office of Pharmaceutical Quality Operations
    FDA/ORA