Best & Brightest Aseptic Content from the 2021 Conferences
33 Presentations Featuring 18+ Hours of Content
No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2021, hand-selected the absolute best and brightest aseptic presentations and packaged them into the ISPE Best of Pharma Series. Access the most premier presentations offering compelling insights, strategies, and best practices from experts representing global health authorities and leading pharma organizations.
Sneak Peek of What to Expect
Watch this short clip from James L Drinkwater, P.E presenting Annex 1 Barrier Technologies, Classification-Qualification (PHSS) for a glimpse of the kind of content you’ll engage within the ISPE Best of Pharma Series: Aseptic.
Presentations in this Package
Risk Reduction, Reliability, and Sustainability: The Drivers for Modernization of Sterile Manufacturing
Speaker:
- Rick Friedman, Deputy Director, Office of Manufacturing Quality, CDER/FDA
Duration: 20 min
Contamination and Cross Contamination Control for Bio Safety
Speaker:
- Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
Duration: 58 min
Vaccines for the World - Insights into Design and Execution of a BSL2 Fill-Finish Facility
Speakers:
- Matthias Angelmaier, Global Product Manager, Isolator Technology, Syntegon Technology GmbH
- Rutger Vandiest, Senior Director - Global Head of Sales, CDMO, Bavarian Nordic
- Mark Miller, Director of Projects, EMEA-UK, IPS
Duration: 41 min
BIOSAFETY Project
Speakers:
- Florian Burkart, Student, ISPE Student Chapter of Albstadt Sigmaringen
- Christoph Bierer, Student, Chair of the ISPE Student Chapter Technical University Munich
Duration: 13 min
Facility Considerations for Next-Generation Sterile Product Manufacturing
Speakers:
- Keith W. Weseli, CPIP, Director of Operations, Midwest Region, CAI
- Peter A. 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
Duration: 50 min
Are You Protecting Your Employees During HPAPI Manufacturing?
Speaker:
- Tom Evans, Director; Environmental Health and Safety, Abzena
Duration: 15 min
Aseptic Meets High-Potent – Setting the Stage for Next Level HPAPI Processing
Speakers:
- Matthias Angelmaier, Global Product Manager, Isolator Technology, Syntegon Technology GmbH
- Christoph Knoop, PhD., Principal Research Scientist, AbbVie Deutschland GmbH & Co. KG
Duration: 15 min
Revision of EU Gmps Annex 1: What Impacts Can We Expect as an Industry?
Speakers:
- Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & CO
- Jean-Francois Duliere, Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate
- James L. Drinkwater, PE, Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, PHSS, F. Ziel GmbH
Duration: 60 min
Update on Annex 1 Eudralex Vol. 4 Revision
Speakers:
- 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.
Duration: 30 min
Annex 1 Barrier Technologies, Classification-Qualification (PHSS)
Speaker:
- James L Drinkwater, P.E., Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, Pharmaceutical & Healthcare Sciences Society
Duration: 13 min
H2O2: Not the Same Old Topic
Speakers:
- Christa B. Myers, Senior Associate, Aseptic & Sterile Market Director, CRB
- Markus Lesch, PhD, Head of Microbiological Validation, Vetter Pharma-Fertigung GmbH & Co KG
- Andreas Demmler, PhD, Team Leader Development Biodecontamination, METALL+PLASTIC GmbH / OPTIMA Pharma
Duration: 60 min
Cycle Development & Validation of Automated AHP Decontamination Processes for Cleanrooms
Speaker:
- Marcus Lesch, PhD, Vetter Pharma-Fertigung GmbH & Co. KG
Duration: 12 min
How Can Hydrogen Peroxide Affect Your Aseptic Process?
Speaker:
- Andreas Demmler, PhD, Team Leader Development Biodecontamination, METALL+PLASTIC GmbH / OPTIMA Pharma
Duration: 18 min
Modular Robotic Fill/Finish Lines
Speakers:
- Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
- Georg Frinke, Senior Engineering Manager, Ferring GmbH
- Thomas Thurn, Director Drug Product Clinical Supply Chain, Janssen Pharmaceuticals
- Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
Duration: 60 min
EM for Fully Automated Aseptic Operations
Speakers:
- Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
- Thomas Thurn, Director Drug Product Clinical Supply Chain, Janssen Pharmaceuticals
Duration: 20 min
Single Use Technologies – Are They Sustainable?
Speakers:
- Dina Manfredi, Director of Sales and Business Development, GMP Systems Inc
- William G. Whitford, Life Science Strategic Solutions Leader, DPS Group
- Magali Barbaroux, Corporate Research Fellow, Sartorius Stedim FMT SAS
- Joe Neroni, Director, Project Farma
- Scott Bertch, Exec. Director, Clinical Site Head, Tenaya Therapeutics
Duration: 60 min
Utilizing Modular Cleanrooms and Single-Use Technologies
Speaker:
- William G. Whitford, Life Science Strategic Solutions Leader, DPS Group
Duration: 15 min
Replacing Silicone Oil Emulsion in Parenteral Filling
Speaker:
- Stefan Schreyer, Alliance Manager, Vetter Pharma International GmbH
Duration: 15 min
Devices and Decontamination—Overcoming Challenges
Speakers:
- Keith W. Weseli, CPIP, Director of Operations, Midwest Region, CAI
- Massimiliano Cesarini, MSEng, Sales Director, Romaco SRL
- Ken Nagai, MBA, Director, New Business Development, Airex Co., Ltd
Duration: 55 min
Decontamination 5.0: From ATMPs and Aging Facilities to our “COVIDed” Office Room
Speaker:
- Ken Nagai, MBA, Director, New Business Development, Airex Co., Ltd
Duration: 15 min
Combination Products Aseptically Filled – Challenges
Speaker:
- Massimiliano Cesarini, MSEng, Sales Director, Romaco SRL
Duration: 15 min
Update PIC/S Annex 2A Draft for ATMPs Revision
Speakers:
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
- Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences
Duration: 15 min
Interactive Regulatory Panel
Speakers:
- David Doleski, Compliance Head for Biologics Quality Operations, Sanofi
- Robert Sausville, Director, Div. Case Management, FDA/CBER/OMPT/OCBQ
- Abdelaali Sarakha, PhD, Senior GMP Inspector, Annex 1 Rapporteur, French Health Products Safety Agency (ANSM)
- Alan Moon, Senior GMDP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA)
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
- Brooke Higgins, Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality, FDA/CDER/OC/OMQ
- Richard Friedman, CDER/FDA
- Thomas J. Arista, Consumer Safety Officer, FDA/ORA
- Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA
Duration: 106 min
Case Study 4: Aseptic Processing Controls
Speakers:
- José Meléndez, Consumer Safety Officer, FDA/ORA
- Brooke Higgins, Senior Policy Advisor, Office of Manufacturing Quality, CDER/FDA
Duration: 75 min
Panel Discussion with Speakers in "Track 4: Cell and Gene Therapy, ATMPs, Data Science Research and Development" and Closing Remarks
Speakers:
- Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences
- Volker Huppert, Chief Development Officer, Glycostem Therapeutics
- René Thürmer, Quality Assessor, BfArm
- Daniel P. DeCollibus, Sr. Scientist, Process Development, Amgen
- Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
- Giuseppina Sandri, Associate Professor, University of Pavia
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TG
Duration: 20 min
Next Steps: New Industry Standard for fill/finish Technology
Speakers:
- Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
- Ute Schleyer, PhD, Project Manager Site Development, Vetter Pharma-Fertigung GmbH & Co
Duration: 30 min
Vaccines for the World - Insights into a BSL2 fill-finish Facility
Speakers:
- Laura Moody, PhD, Product Manager, Syntegon Pharma Technology
- Thomas O’Sullivan, Director of Aseptic Technology, IPS
Duration: 40 min
Is Your Facility on Borrowed Time? Part 1
Speakers:
- Chris Schwartz, Senior Consultant, Blue Matter
- Jason S. Collins, AIA, Director of Process Architecture, IPS-Integrated Project Services, LLC
Duration: 20 min
Single-Use Vs Stainless Steel: Are Hybrid Facilities the Best of Both Worlds?
Speaker:
- Lindsay Smart, CEO, ZETA USA Inc.
Duration: 20 min
Measurement & Control of Hydrogen Peroxide Bio-Decontamination Cycles
Speaker:
- Justin Walsh, Application & Business Development Engineer, Vaisala Inc
Duration: 20 min
Systematically Safeguarding Container Closure Integrity
Speaker:
- Qingyu Zeng, PhD, Fellow & Technical Director, West Pharmaceutical Services
Duration: 35 min
A Data Analytics & AI Driven Approach to Inform Aseptic Processing
Speaker:
- Vaibhav Kshirsagar, Technical Product Manager, IMA Life North America Inc
Duration: 20 min
3D Bioprinting Suite and Facility Design Considerations
Speaker:
- William G. Whitford, Life Science Strategic Solutions Leader, DPS Group