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Showing results 1 - 10 of 12
Monday, March 15, 2021
Opening Plenary Session
8:30 AM - 10:00 AM EDT
Monday, March 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…
Session Leader
Jörg Zimmermann
Vice President Vetter Development Service External Affairs, Vetter Pharma Fertigung GmbH & Co KG
Speakers
Thomas Hartman
President and CEO, ISPE
Jean Hu-Primmer
Global Regulatory Lead, GSK Vaccines
Antonio Moreira, PhD
Vice Provost, Academic Affairs, University of Maryland
Joydeep Ganguly
Senior Vice President – Corporate Operations and Chief Sustainability Officer, Gilead Sciences, Inc.
Welcome & Acknowledgements with Anniversary Video
8:33 AM - 8:45 AM EDT
Monday, March 15, 2021Speaker
Jörg Zimmermann
Vice President Vetter Development Service External Affairs, Vetter Pharma Fertigung GmbH & Co KG
Risk Reduction, Reliability, and Sustainability: The Drivers for Modernization of Sterile Manufacturing
8:45 AM - 9:05 AM EDT
Monday, March 15, 2021This presentation will cover the consequences of variability and benefits of reliability for sterile manufacturing. Learnings from recent inspections will also be briefly summarized…
Public-Private Partnership for Pandemic Preparedness and Response
9:05 AM - 9:25 AM EDT
Monday, March 15, 2021The world has come together during these unprecedented times to respond to the COVID-19 pandemic. Health authorities and regulatory agencies are working closer than ever with industry in an effort to expedite and make available COVID-19 medical countermeasures globally…
Speaker
Jean Hu-Primmer
Global Regulatory Lead, GSK Vaccines
ISPE Foundation Diversity Internship Program (IFDIP)
9:25 AM - 9:45 AM EDT
Monday, March 15, 2021Speakers
Joydeep Ganguly
Senior Vice President – Corporate Operations and Chief Sustainability Officer, Gilead Sciences, Inc.
Antonio Moreira, PhD
Vice Provost, Academic Affairs, University of Maryland
Intersection of ATMPs and New Technologies
10:15 AM - 11:15 AM EDT
Monday, March 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…
Session Leader
Michael Higgins
Sr. Regulatory Compliance Consultant, Higgins Pharma Consulting Group
Speakers
Leslie Southam
QA Manager, Projects, Oxford Biomedica
James Drinkwater, PE
Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, PHSS, Franz Ziel GmbH
Marco Fadda
ATMP Solutions Manager, Comecer, SPA
Rob Roman
Head of Quality Systems & Compliance, Roche / Genentech
Tech Transfer of ATMP Applications from Cleanroom to Isolator
10:20 AM - 10:35 AM EDT
Monday, March 15, 2021The use of Isolators technology in the production of ATMPs has been recently developed. For this reason, we need to set transfer of protocols initially developed for grade B. Habits need to change and procedures carefully tuned to avoid bottlenecks and to ensure smooth running…
Speaker
Marco Fadda
ATMP Solutions Manager, Comecer, SPA
Combined Formulation-Fill-Finish of ATMPs: Lentiviral Vector – Oxbox Case Study Revisited – One Year Out
10:35 AM - 10:50 AM EDT
Monday, March 15, 2021This presentation is part 2 of the Oxford biomedica Oxbox project case study presenting a combined Formulation-Fill-Finish platform for ATMPs including a lentiviral vector for CarT Cell therapy…
Speakers
Les Southam
QA Manager, Vector Product Operations, Oxford Biomedica
James L Drinkwater, P.E.
Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, Pharmaceutical & Healthcare Sciences Society
Contamination and Cross Contamination Control for Bio Safety
10:15 AM - 11:15 AM EDT
Monday, March 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…
Session Leader
Richard Denk
Senior Consultant Aseptic Processing & Containment, SKAN AG
Speakers
Rutger Vandiest
Senior Director - Global Head of Sales, CDMO, Bavarian Nordic
Matthias Angelmaier
Global Product Manager, Isolator Technology, Syntegon Technology GmbH
Mark Miller
Director of Projects, EMEA-UK, IPS
Christoph Bierer
Student, Chair of the ISPE Student Chapter
Technical University Munich
Florian Burkart
Student, ISPE Student Chapter of Albstadt Sigmaringen
Vaccines for the World - Insights into Design and Execution of a BSL2 Fill-Finish Facility
10:20 AM - 10:35 AM EDT
Monday, March 15, 2021The design and implementation of a state-of-the art fill finish facility for viral vaccines faces numerous challenges. Besides the right facility design with focus on BSL2 aspects, this project had the challenge of a very short timeline (fast-track project) combined with facility space limitations…
Speakers
Mark Miller
Director of Projects, EMEA-UK, IPS
Matthias Angelmaier
Global Product Manager, Isolator Technology, Syntegon Technology GmbH
Rutger Vandiest
Senior Director - Global Head of Sales, CDMO, Bavarian Nordic
BIOSAFETY Project
10:35 AM - 10:50 AM EDT
Monday, March 15, 2021The ISPE Student Chapter (SC) Munich is currently working in an industry project named "Biosafety Project" together with all other ISPE D/A/CH SC's…
Speakers
Florian Burkart
Student, ISPE Student Chapter of Albstadt Sigmaringen
Christoph Bierer
Student, Chair of the ISPE Student Chapter
Technical University Munich
Facility Considerations for Next-Generation Manufacturing
12:15 PM - 1:15 PM EDT
Monday, March 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…
Session Leader
Keith Weseli, CPIP
Commissioning and Qualification Project Director, Stevanato Group
Speakers
Peter Walters
Director, Advanced Therapies, CRB
Matthew Hewitt
Head of Clinical Development; Head of R&D, Lonza
Jeffrey Kent
Project Engineer, A/E Projects,, DPS Group
ATMP Facilities: Sterile Manufacturing in the Multi-Modal Environment
12:20 PM - 12:35 PM EDT
Monday, March 15, 2021CMOs need the flexibility to respond to ever-evolving client needs. Likewise, manufacturers who are bringing their ATMP production activities in-house have complex product pipelines and need the flexibility to develop different modalities in parallel, unsure of which will ultimately go to market…
Speakers
Matthew Hewitt
Head of Clinical Development; Head of R&D, Lonza
Peter Walters
Director, Advanced Therapies, CRB
Novel Therapeutic Facilities and Design Challenges
12:35 PM - 12:50 PM EDT
Monday, March 15, 2021Gene/Cell Therapy is a rapidly emerging novel therapeutic technology in the biotech industry. Applications for these therapies are wide-ranging from cellular immunotherapies to cancer vaccines, and new facilities are being designed and built quickly to support the production of these new drugs…
Speaker
Jeffrey Kent
Project Engineer, A/E Projects,, DPS Group
Containment - Understanding Why, When, and What Regulatory Agencies Expect
12:15 PM - 1:15 PM EDT
Monday, March 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…
Session Leader
Christa Myers
Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader, CRB
Speakers
Tom Evans
Director; Environmental Health and Safety, Abzena
Christoph Knoop, PhD.
Principal Research Scientist, AbbVie Deutschland GmbH & Co. KG
Matthias Angelmaier
Global Product Manager, Isolator Technology, Syntegon Technology GmbH
Are You Protecting Your Employees During HPAPI Manufacturing?
12:20 PM - 12:35 PM EDT
Monday, March 15, 2021This presentation will discuss the planning, resources, and capabilities necessary to effectively produce a client’s highly potent active pharmaceutical ingredient (HPAPI) therapeutic, while effectively controlling the risk of exposure to operating personnel…
Speaker
Tom Evans
Director; Environmental Health and Safety, Abzena
Aseptic Meets High-Potent – Setting the Stage for Next Level HPAPI Processing
12:35 PM - 12:50 PM EDT
Monday, March 15, 2021The processing of HPAPI's, especially ADC's faces multiple challenges in terms of equipment design ,execution as well as handling/operation…
Speakers
Matthias Angelmaier
Global Product Manager, Isolator Technology, Syntegon Technology GmbH
Christoph Knoop, PhD.
Principal Research Scientist, AbbVie Deutschland GmbH & Co. KG
Tuesday, March 16, 2021
Revision of EU GMPs Annex 1: What Impacts Can We Expect as an Industry?
9:00 AM - 10:00 AM EDT
Tuesday, March 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…
Session Leader
Jörg Zimmermann
Vice President Vetter Development Service External Affairs, Vetter Pharma Fertigung GmbH & Co KG
Speakers
Jean Francois Duliere
Reg Advisor, ISPE
James Drinkwater, PE
Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, PHSS, Franz Ziel GmbH
Plenary Session
Update on Annex 1 Eudralex Vol. 4 Revision
9:05 AM - 9:25 AM EDT
Tuesday, March 16, 2021Speakers
Jean Francois Duliere
Pharmaceutical Senior Expert, Chair ISPE France Affiliate, Consultant, Chair ISPE France Affiliate
Jörg Zimmermann
Vice President Vetter Development Service External Affairs, Vetter Pharma Fertigung GmbH & Co KG
Annex 1 Barrier Technologies, Classification-Qualification (PHSS)
9:25 AM - 9:40 AM EDT
Tuesday, March 16, 2021Annex 1 is highly important to all involved in sterile medicinal and Advance Therapeutic medicinal products manufacturing as such clarity of requirements is essential…
Speaker
James L Drinkwater, P.E.
Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, Pharmaceutical & Healthcare Sciences Society
H2O2: Not the Same Old Topic
10:15 AM - 11:15 AM EDT
Tuesday, March 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…
Session Leader
Christa Myers
Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader, CRB
Speakers
Markus Lesch, PhD
Head of Microbiological Validation, Vetter Pharma-Fertigung GmbH & Co KG
Andreas Demmler, PhD
Group Leader Development Biodecontamination, METALL+PLASTIC GmbH / OPTIMA Pharma
Cycle Development & Validation of Automated AHP Decontamination Processes for Cleanrooms
10:20 AM - 10:35 AM EDT
Tuesday, March 16, 2021Decontamination of cleanrooms as opposed to Isolators present unique challenges. The volume of the room and the geometric limitations needs to be taken into account…
Speaker
Marcus Lesch, PhD
Vetter Pharma-Fertigung GmbH & Co. KG
How can hydrogen peroxide affect your aseptic process?
10:35 AM - 10:50 AM EDT
Tuesday, March 16, 2021In aseptic production using barrier systems, a variety of differing materials like packaging materials or consumables are present. Nowadays, further new technologies emerge for application of hydrogen peroxide for biodecontamination. However, hydrogen peroxide can interact with materials…
Speaker
Andreas Demmler, PhD
Group Leader Development Biodecontamination, METALL+PLASTIC GmbH / OPTIMA Pharma
Modular Robotic Fill/Finish Lines
10:15 AM - 11:15 AM EDT
Tuesday, March 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…
Session Leader
Klaus Ullherr
Senior Product Manager, Syntegon Technology GmbH
Speakers
Georg Frinke
Senior Engineering Manager, Ferring GmbH
Thomas Thurn, PhD
Director Drug Product Clinical Supply Chain, Janssen Cilag AG
Richard Denk
Senior Consultant Aseptic Processing & Containment, SKAN AG
Project Concept & Decision of a Flexible Fully Automated Pilot Plant
10:20 AM - 10:35 AM EDT
Tuesday, March 16, 2021Speaker
Georg Frinke
Senior Engineering Manager, Ferring GmbH
EM for Fully Automated Aseptic Operations
10:35 AM - 10:50 AM EDT
Tuesday, March 16, 2021In the new draft Annex 1 the use of automated processes and Rapid Micro Method technologies are mentioned. How can be current technologies for EM monitoring replaced through new innovative technologies…
Speakers
Thomas Thurn, PhD
Director Drug Product Clinical Supply Chain, Janssen Cilag AG
Richard Denk
Senior Consultant Aseptic Processing & Containment, SKAN AG
Single Use Technologies - Are they sustainable?
12:15 PM - 1:15 PM EDT
Tuesday, March 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 fa…
Session Leader
Dina Manfredi
Director of Sales and Business Development, GMP Systems Inc
Speakers
William Whitford
Strategic Solutions Leader, Arcadis
Magali Barbaroux
Corporate Research Fellow, Sartorius Stedim FMT SAS
Joe Neroni
Director, Project Farma
Scott Bertch
Exec. Director, Clinical Site Head, Tenaya Therapeutics
Utilizing Modular Cleanrooms and Single-Use Technologies
12:20 PM - 12:35 PM EDT
Tuesday, March 16, 2021Presenters will discuss the unique nature of advanced therapy facilities with a focus on the advantages of using modular cleanrooms and single use technologies in cell and gene therapy…
Speaker
William Whitford
Strategic Solutions Leader, Arcadis
Cell-based Vaccine Production: Improving the Environmental Footprint
12:35 PM - 12:50 PM EDT
Tuesday, March 16, 2021Recent national initiatives and international organizational goals speak to the need to address sustainable vaccine manufacturing. Single-Use (SU) based manufacturing technology provides unique health and safety benefits, while contributing a very small fraction of total plastic waste…
Speakers
Joe Neroni
Director, Project Farma
Scott Bertch
Exec. Director, Clinical Site Head, Tenaya Therapeutics
Process Safety
12:15 PM - 1:15 PM EDT
Tuesday, March 16, 2021Process Safety | Robust and safe processes are the foundation of pharmaceutical manufacturing. Changes to processes are inevitable, but often result in increased risks…
Session Leader
Klaus Ullherr
Senior Product Manager, Syntegon Technology GmbH
Speakers
Stefan Schreyer
Alliance Manager, Vetter Pharma International GmbH
Stephen Jackowell
Director, Manufacturing Quality & Validation, Elanco Corporation
Chip Bennett, PMP
Associate Director, Global CQV, CAI
Replacing Silicone Oil Emulsion in Parenteral Filling
12:20 PM - 12:35 PM EDT
Tuesday, March 16, 2021Siliconization of glass containers is a central process in the preparation for filling of parenterals. A change in the main component, namely the silicone oil emulsion, therefore represents a sensitive intervention in the aseptic process…
Speaker
Stefan Schreyer
Alliance Manager, Vetter Pharma International GmbH
QRM-Based C&Q for an Animal Health Biopharmaceutical Facility
12:35 PM - 12:50 PM EDT
Tuesday, March 16, 2021Elanco Animal Health recently completed a facility expansion at its Fort Dodge, IA, site to accommodate the technical transfer of 70 additional products to the facility…
Speakers
Stephen Jackowell
Director, Manufacturing Quality & Validation, Elanco Corporation
Chip Bennett, PMP
Associate Director, Global CQV, CAI
