2021 ISPE Aseptic Conference
DateMarch 15, 2021Opening Plenary Session | In this opening session, representatives from FDA and from industry will give their high-level perspective on where the Pharmaceutical Industry is heading. The COVID-19 crisis saw drastic changes in the way of working, but also tremendous efforts from the pharmaceutical industry to develop therapies and vaccines for SARS-Cov2 infections. Rapid development, commercial upscaling and distribution are needed to deliver to the patients. Ways of working need to be rethought, procedures developed and implemented at high speed.Session Leader
Vice President Vetter Development Service External Affairs, Vetter Pharma Fertigung GmbH & Co KGSpeakers
President and CEO, ISPEGlobal Regulatory Lead, GSK VaccinesAntonio R. Moreira, PhDVice Provost, Academic Affairs, University of MarylandSenior Vice President – Corporate Operations and Chief Sustainability Officer, Gilead Sciences, Inc.
DateMarch 15, 2021Intersection of ATMPs and New Technologies | Advanced Therapy Medicinal Products (ATMPs), are medicines for human use that are based on genes, tissues, or cells. ATMPs offer novel ways to treat a variety of diseases, and in some instances can be curative. As ATMPs move out of the clinic and become commercialized, manufacturers face traditional challenges of scale-up, transfer and the application of new technologies. This session will explore this intersection. You will hear from experts in the field who will provide valuable technical insight and case studies to the participants.Session Leader
Sr. Regulatory Compliance Consultant, Higgins Pharma Consulting GroupSpeakers
QA Manager, Projects, Oxford BiomedicaHead of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, PHSS, Franz Ziel GmbHATMP Solutions Manager, Comecer, SPAHead of Quality Systems & Compliance, Roche / Genentech
DateMarch 15, 2021The ISPE Student Chapter (SC) Munich is currently working on an industry project named "Biosafety Project" together with all other ISPE D/A/CH Student Chapters. The aim is to develop a guideline on how to define organizational and technical measures for keeping the operator and environment safe when manufacturing cell and gene therapies (CGT) - whilst fulfilling GMP requirements at the same time. In the first presentation the current work of the team regarding Biosafety requirements and implementation is presented, current obstacles are discussed, and future steps are shown. Operator Safety was one of the major goals to combine the flexibility to handle liquid and lyo products with fully isolated equipment, to guarantee the highest degree for a BSL 2 Viral Vaccine Fill and Finish Facility. The major hurdles from a project execution perspective will be presented from Bavarian Nordic/CDMO.
Session Leader
Senior Consultant Aseptic Processing & Containment, SKAN AGSpeakers
Senior Director - Global Head of Sales, CDMO, Bavarian NordicGlobal Product Manager, Isolator Technology, Syntegon Technology GmbHDirector of Projects, EMEA-UK, IPSStudent, Chair of the ISPE Student Chapter Technical University MunichStudent, ISPE Student Chapter of Albstadt Sigmaringen
DateMarch 15, 2021Facility Considerations for Next-Generation Manufacturing | Facility Considerations for Next-Generation Sterile Product Manufacturing | The rise of advanced therapy medicinal products has taken the industry by storm over the past few years. This session will look at the engineering challenges that these products present to facility designers and operators. Flexibility is a key with the reduced batch size associated with these products. This session will address how this needed flexibility can be designed into ATMP manufacturing facilities.Session Leader
Keith W. Weseli, CPIPCommissioning and Qualification Project Director, Stevanato GroupSpeakers
Director, Advanced Therapies, CRBHead of Clinical Development; Head of R&D, LonzaProject Engineer, A/E Projects,, DPS Group
DateMarch 15, 2021Containment - Understanding Why, When, and What Regulatory Agencies Expect | For10 years - the Risk Based Manufacture of Pharmaceutical Products has defined expectations for cross contamination control to protect patients. Understand what cross contamination control: why it is needed, when it is needed, how to determine the extent of what is needed, and what the regulatory environment is regarding cross contamination control to protect patients. This protection translates into requirements to also protect operators.Session Leader
Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader, CRBSpeakers
Director; Environmental Health and Safety, AbzenaChristoph Knoop, PhD.Principal Research Scientist, AbbVie Deutschland GmbH & Co. KGGlobal Product Manager, Isolator Technology, Syntegon Technology GmbH
DateMarch 16, 2021Revision of EU GMPs Annex 1: What Impacts Can We Expect as an Industry? | 2020 saw the commenting of the draft Annex 1, which included many changes to the 2017 version. In this session, we will cover the commenting process both from the ISPE and the PHSS perspective. Selected topics will be discussed in detail. Based on the outcome of the session with regulators from the 2020 ISPE Annual Meeting, we will give an outlook on the implementation of the final guidance issued by EMA.Session Leader
Vice President Vetter Development Service External Affairs, Vetter Pharma Fertigung GmbH & Co KGSpeakers
Reg Advisor, ISPEHead of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, PHSS, Franz Ziel GmbH
DateMarch 16, 2021H2O2: Not the Same Old Topic | H2O2 decontamination has evolved over the years. As aseptic processing has progressed within isolators and within operating rooms, H2O2 has evolved to be used not only as equipment decontamination but also as room decontamination. As ATMP processing has progressed in the past few years, H2O2 has taken on new importance. How should you use H2O2 and what do you need to understand? This panel knows.Session Leader
Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader, CRBSpeakers
Markus Lesch, PhDHead of Microbiological Validation, Vetter Pharma-Fertigung GmbH & Co KGAndreas Demmler, PhDGroup Leader Development Biodecontamination, METALL+PLASTIC GmbH / OPTIMA Pharma
DateMarch 16, 2021Modular Robotic Fill/Finish Lines | 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 is primarily for container handling or replacing a classical transport system. They provide very smooth individual transport and, from a line perspective, a completely modular approach. 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 robotics into a variety of functions was a key topic of discussion during last year’s Aseptic Conference. This year’s session has been designed to continue that conversation and learn from industry experts who are moving forward with implementation.Session Leader
Senior Product Manager, Syntegon Technology GmbHSpeakers
Senior Engineering Manager, Ferring GmbHThomas Thurn, PhDDirector Drug Product Clinical Supply Chain, Janssen Cilag AGSenior Consultant Aseptic Processing & Containment, SKAN AG
DateMarch 16, 2021Single Use Technologies - Are they sustainable? | Over more than two decades, the pharmaceutical industry has increasingly adopted single-use technologies primarily to simplify manufacturing and seemingly to reduce cost; however, the need to reduce environmental burden has a huge impact on these facilities. This session will focus on single-use technologies for gene and cell therapy facilities, while considering the impact on sustainability.
Our first presenter will investigate the impact of single-use with respect to proper cleaning, disposal, and handling, and how it relates to vaccine production including Industry 4.0 and implementation of the 6R's.
Our second presenter will discuss the unique nature of Advanced Therapy Facilities including the advantages and disadvantages of single-use and modular clean room technology as well as flexible manufacturing for gene and cell therapies.Session Leader
Director of Sales and Business Development, GMP Systems IncSpeakers
Strategic Solutions Leader, ArcadisCorporate Research Fellow, Sartorius Stedim FMT SASDirector, Project FarmaExec. Director, Clinical Site Head, Tenaya Therapeutics
DateMarch 16, 2021Process Safety | Robust and safe processes are the foundation of pharmaceutical manufacturing. Changes to processes are inevitable, but often result in increased risks. New processes such as those associated with changes in raw materials or transfer of production to other sites have to be managed properly. In this session, two different examples will demonstrate which methods and structured approaches can be used to effectively maintain process safety, even when they involve major changes.Session Leader
Senior Product Manager, Syntegon Technology GmbHSpeakers
Alliance Manager, Vetter Pharma International GmbHDirector, Manufacturing Quality & Validation, Elanco CorporationChip Bennett, PMPAssociate Director, Global CQV, CAI
DateMarch 17, 2021Devices and Decontamination—Overcoming Challenges | Aseptic products are oftentimes a component part of a Combination Product. These aseptically filled present technical challenges that will be addressed in this session. Additionally, manufacturers are often tasked with utilizing legacy equipment. This session will also present a unique isolator decontamination approach.Session Leader
Keith W. Weseli, CPIPCommissioning and Qualification Project Director, Stevanato GroupSpeakers
Massimiliano Cesarini, MSEngSales Director, RomacoKen Nagai, MBADirector, New Business Development, Airex Co., Ltd.
DateMarch 17, 2021Make vs. Buy in Gene and Cell Therapy and the update on PIC/S Annex 2A Revision for ATMPs will be the topics during this ATMP Session. Which considerations should be used in determining whether an advanced therapy company should manufacture therapies internally, utilize external third-party manufacturers or use a hybrid approach? This presentation from Project Pharma explores the rationale of cell and gene therapy companies using an external CMO or relying on internal manufacturing. Interview with Alyce Maksoud TGA (Therapeutic Goods Administration from Australia) and Francesco Cicirello Adaptimmune (former TGA Subject Matter Expert): Francesco Cicirello’s update on PIC/S Annex 2A Revision for ATMPs will provide a view of his former position as Senior Subject Matter Expert and GMP Inspector at the TGA in Australia and Chair of the PIC/S Annex 2 working Group about the challenges providing a Guideline for ATMPs. Alyce Maksoud, Team Leader Inspection Section, TGA MQB Australian Department of Health, PIC/S Chair of the Working Group on Tissue and Cells. The Interview with Alyce and Francesco will cover most ask questions related to Cell and Tissue Manufacturing. A must to attend for all working with ATMPs.
Session Leader
Senior Consultant Aseptic Processing & Containment, SKAN AGSpeakers
Senior Consultant, Project FarmaSenior Manager, Project FarmaSenior Director, Quality Compliance BioNTainer, BioNTech US Inc.Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
DateMarch 17, 2021Regulatory and Industry Panel | The Regulatory and Industry Panel is one of the highlights of this conference. This session features questions and answers of the most daunting regulatory issues facing regulators and industry at this time. You will learn the most current perspectives of thought leaders regarding your most pressing challenges. The session is completely interactive, providing for a very rich experience. You will not want to miss this session.Speakers
Director, Office of Pharmaceutical Quality Operations, FDA/ORAVice President Vetter Development Service External Affairs, Vetter Pharma Fertigung GmbH & Co KGDirector, Office of Pharmaceutical Quality Operations, FDA/ORAConsumer Safety Officer, FDA/ORATeam Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)Lead Senior GMDP Inspector, MHRAModerator
Head of Global Quality Audit and External Engagement, Sanofi
