The 'PDA Bio Pharmaceutical Aseptic Processing Conference 2025' will be held at the Sheraton Grand Hotel in Incheon from November 4 to 5. This conference is organized to bring together experts from around the world to seek practical solutions and future strategies amidst the changing aseptic bio-manufacturing environment and technology trends.

The conference will delve deeply into global aseptic manufacturing standards and response strategies in light of the rapidly changing regulatory environment and the spread of new therapeutic platforms such as cell and gene therapies (CGT). It is noteworthy as leaders in aseptic manufacturing from Asia, Europe, and the United States will participate directly to share regulatory directions and best practices from each country, and present practical technologies and strategies necessary for aseptic manufacturing.

On the first day of the conference, Dr. David Y.H. Chang from Taiwan Bio-Manufacturing Corporation and Dr. Takumi Miura from the National Institute of Infectious Diseases (NIID) in Japan will take the stage. They are expected to share in-depth perspectives on the development status of cell and gene therapies and the characteristics of the Asian regulatory framework.

Following this, Andy Hopkins from Lachman Consultants in the United States and Steven Bowen from Eliquent Life Sciences will present on global regulatory trends and new approaches to contamination control, while Christian Scheuermann from Charles River Laboratories and David Keen from Ecolab Life Sciences will address monitoring strategies and risk management based on real industry cases.

Ercan Cetin from Johnson & Johnson Innovative Medicine (J&J Innovative Medicine) expressed anticipation, stating, “I am looking forward to sharing cases on how we optimized and standardized smoke studies following regulatory observations.”

In the technology sessions, Bram Keymolen from eyetec will introduce the latest trends in Automatic Visual Inspection (AVI) technology, and Antonio Burazer from Takeda will discuss optimization measures for the fill-finish process. Alan Hoffmeister from Charles River will provide insights into ensuring regulatory compliance and the reliability of inspection results, while Francesco Cicirello from BioNTech will present on aseptic manufacturing methods for the latest biopharmaceuticals such as mRNA and ADC.

Richard Denk from SKAN AG will explain how robotics, closed systems, and isolator technologies are being expanded and applied in actual production environments. Riccardo Marcon from Stevanato Group stated, “I will introduce from an integrated perspective how to effectively perform packaging transfers from non-cleanroom areas to cleanrooms while complying with the latest regulations.”

The main sessions over the two days will broadly cover data integrity and digital regulatory responses, as well as packaging innovation, aseptic transfer technology, and the challenges faced by advanced therapy aseptic manufacturing processes in Korea and Japan. Participants are expected to gain strategic insights and actionable solutions to align with regulatory agencies.

To enhance practical knowledge exchange and networking, interactive programs such as panel Q&A will also be operated. Each session is designed to allow participants to substantially enhance their aseptic manufacturing capabilities through active exchanges of opinions with on-site experts.

Immediately following the conference, on November 6, the 'PDA CCS Strengthening Workshop 2025 (PDA From Findings to Fixes)' will be held at the same venue. This workshop offers tailored educational opportunities to improve practical skills, focusing on the latest approaches to contamination control strategies (CCS), including Root Cause Analysis, Corrective and Preventive Actions (CAPA), cleanroom requalification, and mock audit exercises.

The conference secretariat stated, “Exchanges with experts at the forefront of global aseptic manufacturing will provide practical help to participants in their work,” adding, “Through this program centered on urgent industry issues, we hope participants will directly acquire practical strategies aligned with the latest standards.”

More details can be found on the PDA conference website.

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