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Digital transformation used to be a biotech buzzword, cited in strategic objectives, but not impacting daily life in the lab. Now laboratory software is a foundational element of most biotech discovery workflows. Yet for many bench scientists, finding a software system that’s easy and intuitive to use, affordable, actually reduces their administrative burden, and combines all the digital functionality they need into a single system is still a tall order.
Developed in response to existing product frustrations, Lab Thread combines an electronic laboratorynotebook, molecular biology tools and project management functionality alongside real-time inventory management. Featuringcollaborativechat functionality and AI-driven search, Lab Thread was built to simplifyteam communication, connecting multiple software modules into a single, auditable digital thread that continues to evolve in response to user needs.
1. Fast-Track Digital Investment
Real-world strategies ATMP companies used tosecure board approval for digital projects.
How leading innovators linkregulatory readiness, operational risk, and ROI/ROAto unlock funding.
2. Playbooks from Top-Tier Cell & Gene Manufacturers
Blueprints for success: Proven digital deployment frameworks from CGT pioneers.
Avoiding common pitfalls:Real World Examples ofScalable Implementation in GMP and GxP Environments.
3. Smart Factories, Smarter Decisions: Unleashing AI on the Shop Floor
How AI istransforming batch record management, deviation analysis, and tech transfer.
From dashboards to decisions: Practical examples ofAI-driven insights in action from PD to commercial.
rAAVs are the preferred viral vector for gene therapy due to serotype-specific tropism, durable transgene expression and a growing number of approved and commercialized therapies. Manufacturers and developers are more than ever striving to simplify their manufacturing process whilst improving robustness and cost-effectiveness. Here we present a case study demonstrating the importance of selecting key critical raw materials such as transfection reagent FectoVIR®-AAV, and plasmid pPLUS®AAV-Helper for process performance, combined with a high-throughput production platform that integrates DOE with automated, single-use bioreactors to establish a scalable, high-yield rAAV upstream manufacturing platform suitable for preclinical and clinical supply.
The Inserm We-Met platform, part of the French National Institute of Health and Medical Research, specializes in advanced functional biochemistry and high-resolution protein characterization. Leveraging cutting-edge technologies such as capillary electrophoresis and microfluidic systems, We-Met enables ultra-low sample consumption while maximizing analytical sensitivity and reproducibility—key parameters for robust assay development in clinical research.
This presentation will outline three high-impact errors that can compromise assay integrity and escalate costs in terms of time, resources, and sample availability:
Drawing on our experience in developing and validating complex assays—including one targeting a hexameric protein implicated in multiple sclerosis and post-COVID syndromes—we will provide a structured roadmap for mitigating these risks within an evolving regulatory landscape.
As the field of cell and gene therapies rapidly evolves, so too does the need for a robust logistics framework that ensures the safe and efficient delivery of these therapies to the patients whose lives depend on them. This presentation explores strategies for future proofing , resilience planning and risk mitigation in cell and gene therapy logistics. Key themes will include the importance of proactive contingency planning and risk mitigation, through enhancing collaboration among stakeholders at critical time points and the use of real time data analytics and advanced technologies. By fostering resilience in our logistics planning, we can mitigate risks associated with temperature sensitivity, regulatory compliance, supply chain variability and ultimately improve patient outcomes. Join us to discover actionable insights and best practices that can be applied to enable organizations to thrive in the dynamic environment of cell and gene therapies.
The NIHR is taking decisive action to gain ground internationally in early-phase delivery, advancedmodalities. Hear plans to enhance our research delivery capability to execute the most advanced, complex and high-value commercial studies at pace—and to pivot that capability as science, pipelines and population need change. With a specific focus on early-phase and advanced modalities, vaccines and immune therapies, and oncology, learn how we are accelerating innovation and aligning our national research delivery capability to global drug-development trends and NHS unmet clinical need.
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Advanced therapies are redefining what good patient safety oversight looks like. Novel mechanisms of action, long-term risk potentials and limited clinical exposure place pressure on pharmacovigilance models that were built for products having a pharmacological activity, whilst regulatory expectations are evolving to accommodate such new scientific breakthroughs.
This session follows the safety journey of advanced therapies and challenges the assumption that stronger oversight requires more intense effort. Instead, it explores how innovation-led approaches, including automation, smarter workflows, and proportionate safety design can simplify operations, strengthen compliance, enhance data accuracy and support accelerated development without compromising patient safety.
Induced pluripotent stem cell (iPSC)–derived allogeneic immune cell therapies are poised to transform immuno-oncology, but broad adoption depends on scalable, reproducible, and cost-efficient manufacturing. This presentation highlights the industrialization of iPSC-derived NK and T-cell therapies through Cellistic’s Echo™-NK and Echo™-T manufacturing platforms.
Echo™-NK and Echo™-T address key limitations of donor-derived and autologous approaches by enabling standardized, closed, and automated bioprocesses that support consistent product quality and predictable performance from early development through commercial scale. High-density expansion and robust differentiation workflows significantly reduce manufacturing complexity and cost of goods while maintaining stringent quality attributes. Integrated control strategies ensure consistent identity, potency, and regulatory readiness. Together, these platforms enable the transition from bespoke cell therapy manufacturing to industrialized, commercially viable allogeneic immunotherapies.
www.cellistic.com
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In the dynamic realm of healthcare regulation, economic and innovative drives are increasingly linked, prompting regions like the US, EU, and UK to seek independence and enhance their biomedical appeal through supportive regulations. A significant advancement is the UK's 2025 implementation of a framework for decentralized manufacturing of Advanced Therapy Medicinal Products (ATMPs) near the point of care, ensuring timely patient access. This model connects localized units to a central "Mothership" site, though approval is needed when centralized methods are impractical, limiting immediate benefits for many ATMPs.
Transforming manufacturing and testing protocols is vital to meet new demands, with closed-system manufacturing and rapid microbial testing becoming essential for modular environments. The handling of raw materials, including off-the-shelf options like cell culture media and cytokines, impacts decentralized technology implementation. Automation and computerized data analysis are crucial, placing more responsibility on manufacturers, particularly the Qualified Person (QP), to ensure compliance and efficacy.
Strategic partnerships are vital to support centralized and decentralized manufacturing. Companies like Sartorius offer technological innovations and comprehensive support, helping navigate regulatory complexities and optimize processes. Such partnerships enable manufacturers to adapt to regulatory changes, enhance production capabilities, and efficiently deliver advanced therapies to patients despite potential regulatory delays in regions like the EU and US.