PDA Advanced Parenteral Therapeutics & Quality Summit 2026 to Spotlight ATMP Innovation, Regulatory Trends, and Quality Excellence in Asia

The PDA Advanced Parenteral Therapeutics & Quality Summit 2026, organized by PDA Asia Pacific in collaboration with the PDA Taiwan Chapter, will gather leading experts from across the pharmaceutical, biotechnology, and regulatory sectors at the ILLUME Hotel Taipei on 22–23 September 2026.

(Image: PDA)

Set against the backdrop of rapid growth in advanced therapies and biologics, the two-day summit will provide a focused platform for industry stakeholders to explore emerging trends in advanced therapeutic medicinal products (ATMPs), aseptic processing, contamination control, and quality risk management. With increasing regulatory scrutiny and technological complexity shaping the parenteral landscape, the event aims to support industry alignment on best practices and operational excellence.

Advancing ATMP Development and Regulatory Readiness

The summit will open with a plenary session dedicated to advanced parenteral therapeutics in Asia, offering insights into regulatory expectations and regional ecosystem development. Discussions will include key regulatory considerations for ATMP quality dossiers, alongside Taiwan’s growing capabilities in supporting global supply through its CDMO infrastructure.

A highlight of the program is the dedicated session on gene therapy and in vivo CAR-T technologies, reflecting one of the most rapidly evolving areas in modern medicine. This session will explore regulatory expectations spanning preclinical, clinical, and chemistry, manufacturing and controls (CMC) requirements, as well as the scientific and operational challenges associated with next-generation cell therapies.

Strengthening Contamination Control Strategies

With the implementation of EU GMP Annex 1 continuing to reshape industry practices, a significant portion of the summit will focus on Contamination Control Strategy (CCS) for ATMPs and sterile drug products. Experts will address the design and lifecycle management of CCS frameworks, including:

• Risk-based cleanroom and facility design
• Adoption of closed systems and advanced barrier technologies
• Environmental monitoring and rapid microbiological methods
• Quality system integration and lifecycle governance

Sessions will also examine the practical application of CCS in biologics manufacturing, highlighting regulatory expectations for a holistic, science-driven approach to contamination control. These discussions will be reinforced by case studies and cross-functional perspectives, enabling participants to translate regulatory intent into actionable strategies.

Translating Annex 1 Requirements into Operational Practice

Building on CCS fundamentals, the summit will feature in-depth discussions on Annex 1 implementation, moving from regulatory “intent” to demonstrable evidence of control. Topics will include the establishment of state-of-control frameworks, data trending, and decision-making processes aligned with quality risk management principles.

Practical insights into material transfer in GMP environments will further illustrate how organizations can identify and mitigate contamination risks across cleanroom grades. These sessions aim to equip attendees with the tools and understanding required to maintain compliance while ensuring operational efficiency.

(Image: PDA)

Addressing ATMP-Specific Controls and Supply Chain Considerations

Recognizing the unique complexities of ATMP manufacturing, the program will also explore Annex 2A and material-related controls, including segregation strategies, aseptic connections, and chain-of-identity and custody requirements.

In parallel, discussions on raw materials and vector supply chains will highlight the importance of supplier qualification, contamination risk management, and alignment with PDA’s Points to Consider. These sessions underscore the critical role of integrated supply chain oversight in ensuring product quality and patient safety.

Innovation in Sterility Assurance and Rapid Quality Control

Day two of the summit will turn attention to sterility assurance and rapid quality control technologies. As manufacturers face increasing pressure to modernize microbiological testing in line with regulatory expectations, sessions will examine the adoption of rapid microbial detection methods and their impact on operational efficiency and compliance.

Further discussions will address container closure integrity (CCI) within a CCS framework, with a focus on risk-based selection and verification strategies—particularly in the context of small batch and advanced therapy production.

Enhancing Quality Risk Management and Data Integrity

Quality risk management remains a central theme of the summit, with dedicated sessions exploring the latest developments, including the PDA-ANSI Standard 03-2025. Industry experts will discuss how organizations can strengthen their quality systems through robust risk assessment and data integrity practices.

The program also emphasizes the importance of effective corrective and preventive action (CAPA) strategies. Attendees will gain insights into how to transform regulatory observations into sustainable, system-level improvements that enhance CCS effectiveness and long-term operational resilience.

Taiwan’s Role in Scaling to Global Standards

Reflecting Taiwan’s growing biopharmaceutical capabilities, the summit will feature regional case studies highlighting strategies for scaling operations to meet global quality expectations. Topics will include drug substance to drug product (DS–DP) integration, sterile fill-finish scale-up, and technology transfer, as well as maintaining global regulatory readiness during periods of rapid expansion.

These sessions aim to provide practical perspectives on how regional manufacturers can align with international standards while supporting global supply chains.

A Strategic Platform for the Parenteral Community

Conference Chair Dr. Wei-Kuang Chi, Chief Technical Officer at Taiwan Bio-Manufacturing Corporation (TBMC), emphasized the importance of collaboration and knowledge exchange in advancing the field:

"The development of advanced parenteral therapeutics, particularly ATMPs and gene-based treatments, requires a high level of integration across science, engineering, and quality systems." said Dr. Chi, "This summit brings together stakeholders from across the value chain to address shared challenges, align on regulatory expectations, and accelerate the delivery of safe and effective therapies to patients worldwide."

By bringing together stakeholders from pharma, biotech, regulatory agencies, and academia, the PDA Advanced Parenteral Therapeutics & Quality Summit 2026 is positioned as a key regional event supporting the continued evolution of parenteral manufacturing and quality practices.

Participants will benefit from:

• Insights into emerging technologies and regulatory developments
• Real-world case studies and implementation strategies
• Opportunities to engage with global experts and regional leaders
• Practical approaches to strengthening quality systems and compliance frameworks

Source: PDA