Myers and Harp to lead sessions at the 2022 ISPE Aseptic Conference

CRB’s Christa Myers and Ashley Harp will be leading sessions at this year’s ISPE Aseptic Conference. Myers, co-chair of the program committee, will lead Tuesday’s morning discussions on “Trends in Aseptic Processing Applications” and “Enzyme H2O2-Indicators in Aseptic Production Environment,” and will later facilitate a group discussion between industry experts on the topic of “Optimizing Your Bio Decontamination Cycle Utilizes Enzyme Indicators.” Harp will co-lead Tuesday’s group discussion on “Biosafety and Cleaning” alongside SKAN AG’s Richard Denk. In addition to the in-person event in North Bethesda, MD, the conference is also offered virtually.

Trends in Aseptic Processing Applications: Impacts of Covid, ATMP, Supply Chain and More

March 15 | 7:30-8:45am EST

Session Leader: Christa B. Myers, Senior Associate, Aseptic & Sterile Products Market Director | CRB

Sponsored by Women in Pharma® How has a global pandemic, focus on new therapies, and continued development of technical solutions changed the trends in applications of barrier technology and their implementation? Members of the team will discuss the latest trends related to Covid therapies and associated fast-track schedules, supply chain constraints, ATMP applications, and the great potential for implementing promising solutions such as continuous viable environmental monitoring. The impacts of the combination of these trends on aseptic processing applications reveal both challenges and opportunities. This session will inform as well as plant seeds of thought for sharing and developing ideas for discussion.

Enzyme H2O2-Indicators in Aseptic Product Environment

March 15 | 10:45am – 12:00pm EST

Session Leader: Christa B. Myers, Senior Associate, Aseptic & Sterile Products Market Director | CRB

The H2O2-session shall inspect the possibilities and limitations of their emerging technology of H2O2 indicators. The attendees will learn how the universal normalization approach enables comparison of results independently from day or system dependent influences. This may offer a better way to quantify the VPHP cycle, allowing for better cycle design, control, and understanding. More data leads to improved confidence while opening opportunities in some systems to leverage data for continuous validation models by removing the need for re-qualification entirely.

Barrier Group Discussions: Optimizing Your Bio Decontamination Cycle Utilizes Enzyme Indicators

March 15 | 1:00-2:15pm EST

Session Leader: Christa B. Myers, Senior Associate, Aseptic & Sterile Products Market Director | CRB

A discussion group of industry experts will be on hand to discuss how to optimize vaporize/ionized/fogged hydrogen peroxide cycle utilizing enzyme indicators. Panel will discuss technical aspects, operability, detection, regulatory expectation including the latest research. Join operations and equipment specialists to understand how this technology can streamline you’re approach and timeline.

Containment Group Discussions: Biosafety and Cleaning

March 15 | 1:00-2:15pm EST

Session Leaders: Ashley L. Harp, Process Engineer | CRB and Richard Denk, Senior Consultant Aseptic Processing & Containment | SKAN AG

New therapies such as cell and gene therapy require higher biosafety level during manufacturing. In this breakout various questions concerning containment and cleaning will be discussed.

• How to prepare a manufacturing suite for e.g., BSL 2 product?
• What are the GMP requirements for cross-contamination, and how to protect the operators during production?
• How to prevent contamination but also cross-contamination and what is the right cleaning method and how to quantify clean in aseptic processing?

About the conference:

2022 ISPE Aseptic Conference: Where Regulatory Guidance and Implementation Meet

March 14-15 | North Bethesda, MD and Virtual

The impact of the global pandemic has been felt throughout the pharmaceutical industry and has altered the way we manage everything from operation readiness and supply chain issues to regulatory inspections. Sterile manufacturing practices and strategies are no exception. Benefitting from those lessons learned and preparing to implement new strategies for the future will be the focus of the 2022 ISPE Aseptic Conference, including the critical need to engage and to prepare emerging industry leaders to take on those challenges. With the pending completion of Annex 1 and implementation of PIC/S Annex 2A on the horizon, targeted implementation strategies will be needed, particularly for ATMP manufacturing. The ongoing developments in continuous processing, rapid micro and online testing, and robotics in aseptic processing require ongoing assessment of the impact on sterile products. Case studies, interactive group discussions, and regulatory insights are the benchmarks of this signature conference.

Find more details about the conference here.

CRB is a proud event sponsor.