The second Discovery to Innovation in Animal Health (DIAH) Conference, held in Bruges, Belgium, brought together academic researchers, start-ups, industry, investors, regulators and funders to accelerate translation of scientific discoveries into veterinary products. The conference highlighted that successful translation requires early alignment between researchers and industry, sustained public–private funding and realistic market assessment. A clear target product profile, target-species proof-of-concept data, preliminary safety information, intellectual property protection, manufacturing plans and early regulatory dialogue were identified as central elements of an investable development package. Companion-animal markets are expanding rapidly in different segments, particularly products for age-related chronic diseases, behavioural disorders, and specialised diagnostics, while livestock innovation remains driven by prevention of infectious disease, antimicrobial and antiparasitic resistance, climate pressures and labour constraints. Emerging technologies presented included digital monitoring and artificial intelligence, alternatives to antimicrobials, novel antiparasitics, monoclonal antibodies and nanobodies, stem-cell and gene therapies, advanced vaccine platforms and mucosal delivery systems. Start-ups are increasingly important sources of innovation, but require credible commercial strategies, realistic valuation, scalable manufacturing and appropriate partnerships. Early engagement mechanisms offered by regulatory agencies can clarify evidence requirements and support development of novel therapies. Overall, DIAH demonstrated that multidisciplinary collaboration, shared terminology and early integration of scientific, regulatory, manufacturing and commercial perspectives are essential to de-risk innovation and deliver impactful animal health solutions.
Introduction Chimeric antigen receptor (CAR)-T cell therapies have transformed the treatment of haematological malignancies, yet patients with aggressive, time-sensitive disease remain vulnerable to manufacturing-related treatment delays. Current gold-standard sterility testing under United States Pharmacopoeia (USP) <71> requires a 14-day culture period that is structurally incompatible with the clinical timelines of short shelf-life cell therapy products, positioning sterility assurance as the principal bottleneck to decentralised CAR-T manufacturing. Rapid sterility testing methods have emerged as promising alternatives that may resolve this constraint and expand patient access to treatment. Methods We undertook a narrative review of the literature on sterility testing in cell therapy manufacturing to characterise current methodologies and the translational challenges of microbial detection in cell therapy products. Relevant publications were identified through searches of several biomedical databases, including MEDLINE, EMBASE, PubMed and Cochrane CENTRAL, supplemented by review of reference lists in relevant articles. Eligible studies reported original data relating to sterility testing in cell therapy products or addressed regulatory, infrastructural or procedural considerations relevant to GMP-compliant or decentralised manufacturing environments. Discussion ATP bioluminescence, solid phase cytometry, and PCR-based assays targeting conserved 16S/18S rRNA sequences have emerged as rapid alternatives to compendial methods, delivering substantially shorter turnaround times. However, four translational barriers continue to preclude their widespread integration. First, analytical validation requirements demand matrix-specific performance data generated under actual CAR-T manufacturing conditions. Second, the operational infrastructure demands of decentralised sites, spanning personnel training, equipment qualification, and documentation capacity, often makes such data difficult to generate. Third, regulatory acceptability remains inconsistent across jurisdictions with no harmonised pathway for alternative method approval. Fourth, clinical risk governance is hampered by the absence of standardised protocols for managing discordant results that would support conditional release decisions. In response, we propose a structured three-phase validation framework for the conditional release of CAR-T products using rapid sterility assays, progressing from analytical qualification through bridging and equivalency to conditional release implementation, with defined decision gates at each phase transition. Conclusion Validating and integrating rapid sterility testing into decentralised CAR-T manufacturing workflows offers a credible route to shorter production lead times and broader access to CAR-T cell therapy. Significant barriers remain, however, most notably regulatory fragmentation and a paucity of real-world validation data that currently preclude widespread adoption. The three-phase validation framework proposed in this review provides a structured pathway for conditional release of CAR-T products using rapid sterility assays, progressing from analytical qualification through bridging and equivalency to conditional release implementation, with defined decision gates at each phase transition. Realising the full potential of this framework requires the field to treat regulatory harmonisation and prospective assay validation as jointly necessary conditions for equitable access to cell and gene therapy.
Next-generation sequencing (NGS) enables comprehensive analysis of nucleic acids present in a sample and is considered a promising tool for viral safety testing of biologics. For this purpose, reference viral databases are required to provide broad coverage of potential contaminants. However, in our previous study, mapping RNA sequencing data from adenovirus-infected cells to a highly comprehensive viral database resulted in the detection of the spiked adenovirus as well as numerous additional viral sequences (background viruses). In this study, we constructed a curated viral reference database by restricting the included sequences primarily to viral genomes available in the RefSeq database. We evaluated its performance in terms of detection sensitivity for the target virus represented in the database, the number of background viruses, and the ability to detect viruses that were not included in the database. Our results demonstrate that optimizing reference database composition can significantly reduce background signals while preserving detection capability, highlighting the importance of database design in NGS-based viral safety testing.
On June 23–25, 2025, the International Alliance for Biological Standardization (IABS) hosted the fourth Global Harmonization of Specifications Workshop in Tokyo, Japan, in collaboration with the National Institute of Health Sciences. This first Asian edition convened regulators, industry experts, and stakeholders to advance patient-centric, science- and risk-based approaches for setting specifications in biologics, including vaccines, biotherapeutics, and cell and gene therapies (CGT). The workshop featured a keynote on retinal cell therapy strategies, updates on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Q6 (R1) revisions, case studies demonstrating enhanced versus traditional specification setting, and discussions on pharmacopoeia harmonization and lifecycle management. Breakout sessions highlighted modality-specific challenges: CGT emphasized patient variability and flexible lot release; vaccines focused on potency and legacy assay transitions; biotherapeutics highlighted challenges with the unnecessary specification of non-critical quality attributes.Key themes included distinguishing specifications from process monitoring, leveraging prior knowledge and statistical modeling for clinically relevant ranges, and fostering global reliance to achieve “one product-one specification.” Participants called for case studies, regulatory education, and collaborative platforms to overcome regional divergences, ensuring innovation, supply stability, and patient access worldwide.
