The Parenteral Drug Association (PDA) Asia Pacific will host the PDA Aseptic Processing of Biopharmaceuticals Conference 2026 on 3-4 November 2026 at the Sheraton Grand Incheon Hotel in Incheon, South Korea.

As sterile manufacturers respond to evolving regulatory expectations and increasingly complex biopharmaceutical products, the conference will examine how organizations can strengthen contamination control, protect product quality, and build more resilient aseptic manufacturing operations.

Co-chaired by DeokSeok Oh, PDA Korea Chapter President and representative of Ecolab Life Sciences, and Christian Scheuermann of Charles River Laboratories, the conference will bring regulatory, scientific, engineering, quality, and manufacturing perspectives together in one focused program.

The event will begin with an opening address from Craig Elliott, MBA, President and CEO of PDA.

Moving Beyond Clause-Based Compliance

A central theme of the conference will be the transition from responding to individual regulatory clauses to establishing integrated, lifecycle-managed systems for contamination control and sterility assurance.

The opening technical session, “Annex 1/PIC/S: Closing the Gaps,” will consider current expectations for aseptic processing, common inspection gaps, and practical preparation. It will also explore how sterile manufacturers can develop a Contamination Control Strategy, or CCS, that connects facility design, process controls, monitoring, people, technology, and quality systems.

Presentations will include a 2026 view of current MFDS expectations for aseptic processing and a CCS-driven implementation roadmap for EU GMP Annex 1 and PIC/S Annex 1. The session will conclude with a panel discussion, giving attendees an opportunity to engage directly with the speakers on implementation challenges.

Protecting Sterility Through Primary Packaging and Ready-to-Use Systems

Primary packaging will be another major focus of the program. Two dedicated sessions will examine how ready-to-use, or RTU, systems and container technologies can support sterility assurance throughout the product lifecycle.

Topics will include the transfer of sterile RTU containers into Grade A environments, with risk-based consideration of technologies such as no-touch transfer, electron beam, pulsed light, and vapor-phase hydrogen peroxide. Speakers will also address how facility design, operating strategy, and a site’s CCS should inform technology selection.

Additional case studies and technical presentations will explore:

• Improving vaccine filling efficiency through optimized prefilled syringe processes
• Assessing cyclo olefin polymer prefilled syringes for biologics and biosimilars
• Comparing contamination risks associated with prefilled syringe and autoinjector manufacturing
• Supporting large-volume, patient-centric self-administration
• Integrating container closure integrity, supplier controls, packaging qualification, and lifecycle change management

Contributors to these sessions will represent organizations including Stevanato Group, Terumo Pharmaceutical Solutions, Mycenax Biotech Inc., SCHOTT Pharma, and West Pharmaceutical Services, Inc.

Building Robust Container Testing Strategies

The conference will also examine how manufacturers can establish effective control and testing strategies for primary container systems.

A presentation on container closure integrity will review current regulatory requirements and use industry case studies to describe a practical compliance roadmap. The proposed approach includes deterministic analytical methods, science-based container closure data, lifecycle studies, and risk-based testing strategies.

A separate case study from GC Biopharma will explore the development of an electronically documented defect library using foreign-particle analysis reports and photographs of defective vials. The session will consider how a defect library can support visual-inspection training and education.

Rethinking Modern Fill-Finish Operations

As emerging biopharmaceutical products place new demands on manufacturers, the conference will explore how fill-finish operations are evolving to integrate aseptic processing, containment, automation, and material flow.

A dedicated session will examine the effect of antibody-drug conjugates on fill-finish line concepts. It will address the implications of high product value, increased potency, stringent containment requirements, and smaller batch sizes for modern equipment and facility design.

The agenda will consider containment-driven equipment design, closed and automated architectures, pressure cascades, lyophilizer connectivity, external vial washing, RTU packaging, and strategies for minimizing cross-contamination.

Practical guidance on material transfer will complement this discussion. Attendees will examine contamination risks along material pathways from warehouses to critical cleanroom zones, including risks associated with first air and open-door interventions.

Turning Inspection Observations into Prevention

On Day 2, the program will open with “Inspection Readiness: From Observations to Prevention.”

The session will explore how aseptic manufacturing sites can build a defensible inspection narrative by connecting their CCS, Quality Risk Management activities, and Annual Product Review or Product Quality Review processes.

Speakers will examine the conditions that can lead to warning letters and critical observations in sterile manufacturing, along with approaches intended to prevent repeat findings. The program will also consider how contamination control strategies must work across organizational boundaries, particularly between drug-product manufacturers and suppliers of sterile ready-to-use primary packaging.

A presentation from Lotte Biologics will address the relationship between data integrity and quality culture. It will consider how everyday behaviors, deviation practices, investigation quality, and a Stop-the-Line culture can support sustainable compliance.

Examining Airflow Evidence That Withstands Scrutiny

Airflow visualization studies, commonly known as smoke studies, remain an important tool for understanding contamination risk in cleanrooms. They can show how facility design, equipment, personnel activity, and material movement affect HEPA-filtered airflow under static and dynamic conditions.

The conference session “Airflow Verification: Smoke Studies that Survive Scrutiny” will review regulatory expectations, applicable guidance, airflow-visualization technology, and the ASTM E3379-25 standard for critical airflow visualization studies.

The program will also consider the use of Computational Fluid Dynamics in aseptic risk decisions, including when modelling can provide useful evidence and when it may mislead. Discussion will focus on connecting computational analysis to empirical airflow evidence.

Connecting Microbiology, Engineering, and Human Behavior

The session “Microbiology in CCS: Asepsis is Micro + Engineering + Behavior” will reinforce the need for a multidisciplinary approach to contamination control.

Drawing on more than a decade of practical experience, one presentation will examine the validation of rapid sterility testing across products including monoclonal antibodies, vaccines, cell therapies, and medical devices. It will focus on primary validation, method suitability, equivalency testing, and risk-based approaches designed to withstand regulatory scrutiny.

The conference will also feature an update on Low Endotoxin Recovery and the revision of PDA Technical Report 82. The presentation will examine evolving scientific understanding of the phenomenon and anticipated changes in the revised report, which the agenda notes is expected in the third or fourth quarter of 2026.

Managing Risk Beyond the Filling Line

The final conference session will broaden the discussion to risks across the aseptic manufacturing network.

A presentation from Samsung Biologics will provide an overview of process validation for aseptic drug-product manufacturing, including the FDA lifecycle approach of Process Design, Process Qualification, and Continued Process Verification. It will also examine how Critical Quality Attributes can be linked to process risks when establishing a Process Performance Qualification strategy.

The program will conclude with a session on viral safety and cross-contamination prevention, covering segregation, closed systems, waste flows, and decontamination strategy in aseptic facilities.

Complimentary Pre-Conference Site Visit

Conference attendees will also have the opportunity to participate in the PDA Site Visit at Daewoong Pharmaceutical and Daewoong Bio 2026 on Monday, 2 November.

The visit will include the Daewoong Pharmaceutical Nabota Plant and Daewoong Bio’s newly launched Bio-Center. Participation is free for conference attendees.

Post-Conference CCS Workshop

Following the main conference, PDA will present the PDA Contamination Control Strategy CCS Workshop 2026 on Thursday, 5 November, also at the Sheraton Grand Incheon Hotel.

The workshop is designed to help participants understand what EU GMP Annex 1 requires of a CCS and distinguish a risk-based, living strategy from a documentation exercise.

Through technical presentations, group activities, a tabletop exercise, and panel discussion, participants will consider how to:

• Apply Quality Risk Management tools to identify contamination risks and gaps
• Develop the framework for an aseptic-process CCS
• Integrate cleaning, disinfection, and cleanroom qualification into contamination control
• Address human factors and contamination risks in day-to-day operations
• Maintain the CCS through governance, defined review cadence, and continuous improvement
• Prepare for the expectations of inspectors and recognize areas in which companies commonly fall short
• The workshop faculty will include specialists from Charles River Laboratories, ELIQUENT Life Sciences, Microrite, Inc., Cytiva, and Contec Cleanroom.

Advancing Practical Sterility Assurance

By linking regulatory expectations with practical manufacturing, scientific, and engineering experience, the PDA Aseptic Processing of Biopharmaceuticals Conference 2026 will provide a forum for examining sterility assurance across the full aseptic-product lifecycle.

The combined conference, site visit, and workshop program will offer participants multiple ways to explore current challenges, exchange knowledge, and identify practical ideas that can be applied within their own facilities and organizations.

Event Details
Event: PDA Aseptic Processing of Biopharmaceuticals Conference 2026
Dates: 3-4 November 2026
Venue: Sheraton Grand Incheon Hotel, South Korea
Organizers: PDA Asia Pacific 

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