2021 ISPE Aseptic Conference

Setting the Pace for 30 Years!

Thank You for Making this Virtual Conference a Huge Success!

Foundation of Pandemic Preparedness & Response

The 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.

During the opening plenary session for the 2021 ISPE Aseptic Conference, keynote presenter Jean Hu-Primmer, Global Regulatory Lead, GSK, spoke on how the public sector's steadiness and resolve coupled with the innovation and agility of the private sector can move mountains to save lives.

Intersection of ATMPs & New Technologies Q&A Robotics Regulatory

During the 2021 ISPE Aseptic Conference session "Intersection of ATMPs and New Technologies," moderator Michael Higgins, Senior Compliance Advisor, Genentech, posed the question: What is the level of concern that regulators have regarding robotics?

Watch this clip to hear what the expert panelists had to say!

James L. 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
Leslie Southam
QA Manager, Projects
Oxford Biomedica

Facility Considerations for Next Generation Manufacturing Q&A

The rise of advanced therapy medicinal products has taken the industry by storm over the past few years. The 2021 ISPE Aseptic Conference session "Facility Considerations for Next-Generation Manufacturing" took a look at the engineering challenges that these products present to facility designers and operators.

Watch this clip to hear what Jeffrey Kent, and Project Engineer, A/E Projects, DPS Group Global, and Peter Walters, ATMP Director, CRB, had to say when session moderator Keith Weseli, CPIP, Director of Operations, Midwest Region, CAI, posed the question: What kind of strategies do you use to steer your owner clients to delivering a more focused solution?

Annex1 Plenary Q&A Pre Post Batch Glove

Day 2 of the 2021 ISPE Aseptic Conference kicked off with the plenary session “Revision of EU GMPs Annex 1: What Impacts Can We Expect as an Industry?” covering the commenting process both from the ISPE and the PHSS perspective.

Watch this clip to get a taste of the closing Q&A as you hear from Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma, James Drinkwater, PE, Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, PHSS, F. Ziel GmbH, and Jean François DULIERE, Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate.

H2O2: 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.

Watch Now: During the 2021 ISPE Aseptic Conference, moderator Christa Myers, Sr. Associate, Pharmaceutical Market Director, CRB, asked featured speakers Andreas Schachtschneider, PhD, Head R&D Biodecontamination Process, METALL+PLASTIC GmbH / OPTIMA packaging group GmbH, and Markus Lesch, PhD, Head of Microbiological Validation, Vetter Pharma, to share insights on general trends that they're seeing between H2O2 and certain types of materials.

Single-Use Technologies Closing Q&A

Are vendor qualification packages suitable to address all regulatory questions that could be asked for the process validation?

Moderator Dina Manfredi, Director of Sales and Business Development, GMP Systems, Inc, posed this question during the closing Q&A with speakers from the session "Single-Use Technologies - Are They Sustainable?" at the 2021 ISPE Aseptic Conference.

Devices Decontamination

Robust decontamination for ATMPs, especially for material transfer, has been challenging due to reagent penetration, time inefficiency, temperature increase and so on.

During the 2021 ISPE Aseptic Conference, Ken Nagai, MBA, Director, New Business Development, Airex Co.,Ltd, introduced an innovative decontamination method called UltraDecon that can be applied to cell transfer as he took us through his presentation "Decontamination 5.0: From ATMPs and Aging Facilities to our “COVIDed” Office Room."

Watch this clip to hear Ken highlight the ultrasonic decontamination method.

Regulatory View ATMPs Make Buy Closing

Make vs. Buy in Gene and Cell Therapy and the update on PIC/S Annex 2A Revision for ATMPs were a focus during one of the final sessions for the 2021 ISPE Aseptic Conference.

In this video clip, session moderator Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG, asks featured speakers to share their insights on developing or addressing a cross-contamination control strategy.

Conference Highlights