Advancements & Innovations in Decontamination and Single-Use Technology
Building off of the success of the 2022 ISPE Aseptic Conference, the program committee has developed a robust program covering key areas in aseptic manufacturing, processing, and filling for students, emerging leaders, and seasoned industry professionals. Topics such as cell and gene therapies, advanced therapeutic medicinal products (ATMPs), barrier and isolator technology, single-use components, aseptic quality risk management (QRM), aseptic fill/finish, contamination control strategy (CCS), revisions to Annex 1, and more will all be covered.
The program committee vetted over sixty proposals and are excited to welcome speakers all across the globe to present to you in person in Bethesda, MD. The speakers represent highly touted names in the aseptic industry such as Moderna, Oncomed, INCOG BioPharma, ThermoFisher, Civica Rx as well as well-renowned vendors who provide complex solutions for the industry. The speakers will highlight and share their unique and accomplished perspectives in the topical tracks.
The conference is structured with keynote presentations, topical tracks, industry and regulatory panels, as well as proctored discussion groups. The opening keynote will feature Brook Higgins from the FDA and focus on the critical role of environmental monitoring and preventative steps to take for a strong sterility assurance program to reduce positive sterility tests. The second day’s keynote will feature Emily Craven from Boston Scientific and focus on the growing opportunity to optimize sterilization technology for active pharmaceutical ingredients (API) that is used to formulate sterile dosage forms and how the current supply chain constraints will welcome innovation in this area.
The conference will have a highly anticipated industry panel solely focusing on the revisions to Annex 1. With the looming date of August 25th, 2023, for the revised GMP requirements to take place, the panel will address key areas of the revisions and feature ISPE members who took part in the consultation rounds for the revision. Questions that will be addressed for implementation include:
- How can the Contamination Control Strategy be implemented into an existing quality system?
- What should be considered when deciding between restrictive access barrier systems (RABS) and isolators to protect the product?
- What should be considered to mitigate contamination risk for pre-use post sterilization integrity tests (PUPSIT)?
- How should the new requirements around aseptic process simulations (APS), also known as media fills, be implemented?
- What impacts to cGMP facility design are expected?
New for this year, the program committee has developed an introductory workshop-structured session scheduled for the afternoon prior to the first day of the conference. The Aseptic 101 session is intended for high school students, emerging leaders, and first-time conference attendees. The session will address the basics surrounding aseptic processing and equipment as well as an introduction to ISPE in general. The session is available to all conference attendees with registration opening on site prior to the beginning of the session.
I am particularly proud of my session “Decontamination and Single-use Systems,” where the speakers will explore the advancements and innovations in decontamination and single-use technology to comply with the newly revised EU GMP Annex 1. Elizabeth McQuade from CURIS System will give examples of how using new gaseous hydrogen peroxide (H2O2) can reduce downtime from off-gassing following treatment and have improved material compatibilities. This presentation is followed by Andreas Demmler from METALL+PLASTIC GmbH / OPTIMA Pharma. He will explore the development and validation of H2O2 cycles using enzyme indicators. The understanding of enzyme indicators and their possibilities grows as more data about the influence of temperatures, storage conditions, timing of the reading, and degree of inactivation is gathered through experimental results. As the expectation is that the emerging technology of enzyme indicators will become established in the industry over the next few years, it is beneficial to know the current state of the art regarding this technology. Lastly, a joint presentation by Juergen Michael Metzger from Sartorius and Scott Sznyter from Breakthrough Medicines will discuss the implications of the revised EU GMP Annex 1 on the importance of cross-contamination prevention and operator risk. Attendees can expect to learn the steps to switch to using single-use equipment while complying with the requirements set by the revised EU GMP Annex 1.
Lastly, Women-in-Pharma® are hosting a breakfast session with an emphasis on developing your brand and moving your career in the direction you have dreamed of to accomplish your goals. Attendees will be able to hear from women in the pharmaceutical industry who have turned their passions into reality with their current careers. This year’s breakfast session is hosted by Nidhi Shah, Director of Aseptic Processing SME, Sanofi Pasteur Swiftwater, Chervee Ho, Director of Business Development and Key Account Management, Asia Pacific, Vetter Pharma, and Christa Myers, Senior Fellow, Market Director Aseptic and Sterile Products, CRB. There will be a leadership and career advancement book raffle for all those in attendance.
The 2023 ISPE Aseptic Conference is shaping up to be an event you cannot afford to miss! With ample opportunities to network with peers and leading industry professionals as well as learn about new aseptic products and technologies in the exhibit hall, the conference agenda has been designed to answer all of your aseptic processing questions and address your current needs. The program committee hopes to see you in North Bethesda, MD from March 5th to the 7th.
