2026 Application of Automation and Intelligent Systems to Bioassays Conference
Virtual | December 2-3, 2026
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Conference Info
This two‑day virtual event explores how automation, robotics, and AI/ML are reshaping CMC potency assays across the biopharmaceutical lifecycle. As regulators intensify scrutiny on data integrity and assay reproducibility, this conference highlights how automated platforms from simple liquid handlers to fully robotic systems strengthen cost-effective CMC strategy, analytical rigor, and inspection‑ready execution.
Attendees will gain practical insights into automated assay design, qualification, validation, lifecycle management, digital data capture, AI‑enabled analytics, and global regulatory expectations. Special emphasis is placed on how automation reduces variability, enhances data integrity, and supports defensible decision‑making across diverse biopharmaceutical modalities.
Designed for CMC, QA/QC, Analytical Development, Bioassay, Automation Engineering, Regulatory Affairs, and Technical Operations professionals, this event equips teams to build automated potency programs that are fit‑for‑purpose, compliant, scalable, and resilient across the product lifecycle.
Quick Links
December 2-3, 2026
Virtual Conference
Deadlines
Abstract Submission: June 26, 2026
Next Price Increase: Nov. 18, 2026
Registration Closes: December 1, 2026
Agenda
The draft 2026 Virtual Automation Conference agenda is here! Check the agenda for updates as we finalize our schedule.
2026 Abstracts
Addition Of An Automated Method Into A Validated Manual ELISA
Speaker To Be Announced
Abstract: Coming Soon
Building Future-Ready Bioassay Capabilities: Automating Bioassays for Scalable Product Development
Speaker To Be Announced
Abstract: Coming Soon
Four Years, Multiple Assays, One Goal: Lessons Learned from Semi Automation of Potency Testing in GMP
Frances Reichert, Technical Specialist Biologics, Eurofins BPT
Abstract: Potency assays are a critical component of biologics release testing. However, they often rely on manual workflows, resulting in operator dependency, variability and limited sample throughput. Semi-automation can improve the robustness and efficiency of assays, but its implementation in a GMP environment raises important questions regarding comparability, method qualification and validation, and regulatory acceptance.
In this presentation, we share insights from over four years of implementing semi-automated potency assays in a GMP setting. Rather than focusing on a single assay modality, we present our experiences with multiple assay types to identify common success factors and recurring challenges. A key lesson is that automation must be intentional: selecting the appropriate level of automation is crucial to avoid unnecessary complexity whilst preserving assay performance and biological relevance.
Through selected case studies, we will highlight the transition from manual to semi automated workflows, covering implementation, qualification, validation, and routine use. These examples demonstrate how semi-automation can reduce manual variability while introducing new considerations, such as the effects on incubation timing, execution consistency, and assay control strategies. We also discuss practical approaches to establishing system and sample suitability tests, defining qualification and validation strategies, and maintaining long-term assay performance throughout the assay lifecycle.
Overall, this presentation provides practical guidance on implementing semi automation in potency testing, enabling improved assay robustness and throughput, while maintaining compliance with GMP and regulatory expectations.
Contributing Authors:
Frances Reichert
Eurofins BioPharma Product Testing Munich GmbH, Planegg, Germany
Automation of a Cell-Based Potency assay for Adalimumab using both the Hamilton STAR liquid handling robot and Integra ViaFlo
Speaker To Be Announced
Abstract: Coming Soon
Work Smarter, Submit Faster: AI-Powered Document Intelligence Reimagined
Anastasija Serdega, Senior Research Associate, Autolus Therapeutics plc
Abstract: AI document intelligence tools are being marketed to regulatory teams with promises of faster, cleaner submissions. Much less attention goes to how those claims should be tested before an organisation relies on the output.
This session approaches the question from outside regulatory affairs. As an analytical development scientist who has authored the analytical methods section of a BLA, the speaker applies the same discipline used to validate a GMP method: define what “accurate” means, test it against known answers, and understand where the system is likely to fail.
The talk starts with documented cases, including FDA warning letters, technical validation criteria and cross-sectional refuse-to-file studies. These show where submission quality actually breaks down and which of those failures AI could plausibly address. It then gives attendees a simple way to think about these tools: as predictive models rather than readers. It also separates terms such as precision and accuracy, which mean different things in analytical science and machine learning.
A central focus is why scientific and analytical tables remain difficult for current AI systems, and why that matters for Module 3 content. Evidence is organised by type rather than by vendor. Attendees leave with a six-question checklist for evaluating accuracy claims, demonstrated through a live worked example they can apply to any tool under consideration.
Process Understanding Before Platform Selection: Building Reliable Automated Assay Workflows
Mona Shehata, Associate Principal Scientist, AstraZeneca
Abstract: Laboratory automation is often viewed as technologically challenging, yet our experience suggests that successful adoption depends far more on understanding the processes than on selecting platforms. We describe our progression from manual workflows through semi-automation and ultimately to advanced liquid-handling systems, using cell-based assays as case study.
A key lesson for successful automation implantations was that critical aspects of assay execution exist as undocumented analyst knowledge. Before automation can succeed, these factors must be identified and translated into explicit process instructions.
Semi-automation proved to be a valuable intermediate stage. Standard electronic pipettes mounted on robotic arms enabled controlled evaluation of workflow parameters while maintaining close analyst oversight. These systems supported rapid optimization, side-by-side comparison with manual execution, and identification of critical process variables before transfer to larger/complex liquid-handling platforms. Across multiple workflows, mixing behaviour emerged as one of the most influential factors affecting assay performance and reproducibility.
As workflows and understanding matured, automation efforts transitioned to complex automated systems developing reusable workflow components for common operations such as serial dilution, reagent addition, and cell dispensing. Comparisons between manual, semi-automated, and automated execution demonstrated that comparable outcomes could be achieved, but only after careful optimization of workflow details and platform-specific implementation strategies. This improved consistency, reduced duplicated effort, and supported adoption across projects.
Overall, rather than considering automation as a single complex step change, capability was built incrementally, using each stage of automation to improve understanding, reproducibility, and readiness for future scale.
Contributing Authors:
Mona Shehata, Theo Jackson
AstraZeneca, Cambridge, United Kingdom
Biomarker Identification For Immunotherapy Development
Speaker To Be Announced
Abstract: Coming Soon
Practical AI Implementation in GMP Bioassays: From Pilot to Governance
Mohamad Toutounji, Consultant, Molgenium
Abstract: PIC/S Annex 22 currently restricts GMP-critical AI applications to static, deterministic models — a constraint often read as conservatism but better understood as an auditability requirement. This talk translates that requirement into a practical implementation pathway for bioassay laboratories moving from pilot-stage AI/ML tools toward validated, inspection-ready deployment.
The presentation covers three stages of maturity: (1) low-risk advisory use cases — assay trend monitoring, outlier flagging, and drift detection — that deliver value without triggering full model validation burden; (2) the credibility evidence package required to justify a model’s Context of Use (COU) against its regulatory risk tier, aligned with the emerging FDA–EMA Guiding Principles of Good AI Practice; and (3) the governance infrastructure — change control, re-qualification triggers, and continuous drift monitoring — needed to keep a deployed model in a validated state over its lifecycle, not just at initial qualification.
Grounded in real bioassay validation work (including RIG-I-based dsRNA quantification method development), the talk argues that the binding constraint on AI adoption in GMP bioassays is not model performance but governance readiness — and that laboratories under-invest in the latter relative to the former. Attendees will leave with a practical maturity framework they can apply to their own automation and AI/ML programs, distinguishing what can move fast (advisory, non-release-impacting tools) from what requires the full weight of validation (anything touching lot release or specification decisions).
Contributing Authors:
Mohamad Toutounji
Molgenium, Dusseldorf, Germany
Industry
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Education Sessions
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Podium Presentations
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Quality Aspects Ticket
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Education Sessions
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Podium Presentations
Academic
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Gvmt/Health Authority
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Networking Reception
Registration Early Bird Prices:Prices increase end-of-day November 18, 2026.
Group Discounts (only applicable to Industry tickets):
2026 Planning Committee
Ulrike Herbrand
Charles River Labs
Siân Estdale
ACM Global
Laureen Little
BEBPA
Jane Robinson
BEBPA
Perceval Sondag
Sanofi
Anton Stetsenko
BioQual Consulting
Leslie Wagner
US FDA