“Industry Panel: Challenges of New Modalities: Radiopharmaceuticals, Cell and Gene-Therapies, and Antibody Drug Conjugates”
Emerging therapeutic modalities introduce distinct challenges to the manufacture of sterile medicinal products. Radiopharmaceuticals and antibody‑drug conjugates (ADCs) require specialized containment and handling strategies due to radiological hazards, potent cytotoxic payloads, and complex conjugation processes. Advanced therapy medicinal products, including cell‑ and gene‑based therapies, frequently involve patient‑specific manufacturing, rapid turnaround times, and closed or semi‑closed aseptic workflows that differ significantly from traditional batch‑based operations.
The discussion examines how industry adapts manufacturing and contamination control strategies to ensure the production of safe, sterile products across diverse emerging modalities. Experts from organizations actively engaged in these technologies evaluate technical lessons learned from recent facility designs, process implementations, and regulatory interactions, emphasizing segregation requirements, risk-based facility zoning, aseptic processing controls, and supply chain constraints associated with individualized therapies.
Panelists from organizations actively engaged in these modalities also present real‑world examples illustrating how companies are addressing these challenges, including approaches to facility and process design, operator protection, radiological safety, environmental monitoring, and quality‑system integration. The session closes with an open Q&A, allowing audience members to pose technical questions and facilitate deeper discussion and knowledge exchange.
“Navigating Annex 1 Compliance: Strategies and Learnings”
Over the past two years, sterile product manufacturers—from small contract manufacturing organizations (CMOs) to large global operations—have experienced significant operational and compliance challenges. For European Marketing Authorization Holders (MAHs) with sterile manufacturing networks distributed across multiple regions, maintaining regulatory alignment while managing diverse cultural and operational practices has required tailored, risk‑based approaches.
This presentation outlines how a Japan‑based global specialty pharmaceutical company addresses EU GMP Annex 1 compliance across both CMO partners and internal manufacturing facilities. It provides technical examples drawn from audit observations, including the identification and mitigation of contamination‑control risks, the evaluation of aseptic process robustness, and the implementation of corrective and preventive actions aligned with overall Annex 1 expectations.
The session also examines industry approaches to overseeing CMO compliance with Annex 1 requirements, including governance structures, quality‑oversight models, and performance monitoring frameworks. In addition, it describes how qualified persons conduct batch certification within this evolving regulatory landscape, emphasizing their continuous involvement in Annex 1 readiness assessments, risk reviews, and decision‑making processes related to batch disposition.
Join the 2026 ISPE Aseptic Conference
Don’t miss the 2026 ISPE Aseptic Conference, which will feature a variety of tracks and themes impacting aseptic processing. Review the following blog posts to learn more about what’s in store at this year’s conference.
Register for the 2026 ISPE Aseptic Conference
