Booth 502
Date
September 30 - October 2, 2025
Stay tuned for more talks and posters.
| Time | Type | Description | Room / Location | Presenter |
| 10:00 | PLENARY | Architecting Discovery: Getting the Most Out of Data, AI, and Automation
Genedata | Plenary Theater | Jana Hersch |
| 18:10 | POSTERS | NGS-Powered CMC Strategies: Enhancing Quality and Compliance in Biologics Manufacturing Poster: 69
In the rapidly evolving field of biological drug products, Chemistry, Manufacturing, andControls (CMC) is instrumental in ensuring product quality, safety, and regulatorycompliance. Biopharmaceutical companies are increasingly adopting next-generationsequencing (NGS)-based assays to support the development and characterization ofstarting materials, such as cell lines or vectors.Biological drug modalities, such as antibody therapies, must be rigorously characterizedto meet stringent quality standards. To mitigate manufacturing risks, for examplecontaminations or genetic instabilities, and to ensure regulatory compliance, it isessential to characterize Critical Quality Attributes (CQAs), including identity, integrity,and purity of the production cell line.By leveraging NGS technology, biopharmaceutical companies can enhance thereliability and consistency of their manufacturing processes, delivering safer, moreeffective GMP-grade therapies to patients faster. For this to succeed, validated in-houseNGS platforms are required. Successful validation demands careful control of methodvariability, as well as instrument and protocol standardization. Furthermore, robust datahandling and strict adherence to regulatory requirements are essential.Genedata Selector® is an enterprise software platform that automates and acceleratescomplex NGS data processing, analysis, interpretation and decision-making processes,supporting companies in overcoming CMC challenges in biologics production.
Genedata | Poster Area | Christoph Bredack |
| 18:10 | POSTERS | High-Throughput Mass Spectrometry Analytics for ML/AI-Ready Drug Discovery Poster: 68
As the demand for scalable mass spectrometry (MS) analytics increases, standardized dataacquisition and automation of time-consuming manual processes are needed to deliver high-throughput,qualityresults.Bystreamlininginformationexchangewithcentralizeddatamanagement systems, data processing from different vendors, and result review, the GenedataBiopharma Platform enables large-scale screening and generation of structured datasets forML/AI-ready drug discovery, supporting enterprise-level biopharma digitalization and deliveringfaster insights for decision-making.
Genedata | Poster Area | Laura Radu Parlog |
| 18:10 | POSTERS | Workflow Automation for Ultra-High-Throughput Spectral Shift Analysis Poster: 73
HighThroughputSpectralShift(HT-SpS)isacutting-edgebiophysicalscreeningtechnology that enables direct detection of binders and allosteric modulators, includingboth small molecules and biologics. For the first time, hits can be identified through directbiophysical measurements at the earliest stages of drug discovery. The NanoTemperDianthus uHTS is a high-performance instrument based on SpS technology, capable ofmeasuring a full 1536-plate in approximately 7 minutes.Here we present an automated end-to-end workflow in Genedata Screener (part of theGenedata Biopharma Platform) that enables HT-SpS hit detection with unprecedentedthroughput. [YA1] Genedata Screener fully automates the entire analysis workflow forDianthus uHTS data, including data loading, processing, quality control, result calculation,hit identification, and reporting to downstream applications. It efficiently handles diverse(HT-)SpS datasets, enables interactive review of raw spectral scan graphs at any step,performs automated outlier detection, provides robust QC metrics, and supports sampleranking via direct affinity constant determination.With the addition of SpS to the broadsuite of assay technologies covered, Genedata Screener thus continues to accelerate theidentification of new molecules from the beginning of the discovery cycle.
Genedata | Poster Area | Simone Borgoni |
| 18:10 | POSTERS | An Automated High Throughput Engineering Platform for AI-Supported Developability Predictions Poster: 70
An Automated High Throughput EngineeringPlatform for AI-Supported Developability PredictionsCombinatorial selection strategies and advances in protein and nucleotide engineering havebeen successful in generating novel large-molecule therapeutics. Bi- and multi-specificantibodies, antibody drug conjugates (ADCs), chimeric antigen receptors (CARs), engineered T-cell receptors (TCRs), and other formats offer new approaches to treatment. However, theefficient design, production, and multi-dimensional characterization represent a major challenge,especially when creating those highly engineered therapeutic candidates in high throughput.Here, we demonstrate how the Genedata Biologics®platform enables a fully automatedworkflow for next-gen modalities, integrating all steps from selection, molecular biology,expression, purification, and analytics. Built-in workflows for automatedin silicomoleculeassembly mechanisms allow efficient design of large panels of novel biomolecules. Dedicatedtools for pooled cloning deconvolution and automated chain pairing recovery automate thegeneration of tens of thousands of molecule variants that are then tested for drug-likeproperties. Data from multi-parametric screening is captured in the system’s highly structureddatabase and systematically analyzed to evaluate the candidates under consideration of allmeta-data, genomic, and phenotype information. We demonstrate the platform’s capabilities byillustrating a fully integrated developability and manufacturability assessment using a novelAI/ML approach for large panels of bi-specific molecules. Further, we illustrate how the platformcan be used to automate the full range of innovative modalities, including CAR-Ts, AAVs, andmRNA-LNPs.
Genedata | Poster Area | Sebastian Kolinko |
| 18:10 | POSTERS | Structured Knowledge Management Platform for Bioprocess Development Poster: 71
Centralized structured data across multiple groups is critical for integrated bioprocessdevelopment with advanced data analytics, machine learning (ML) and artificial intelligence (AI)approaches, and efficient reporting to regulatory agencies. Growing adoption of high-throughputand process analytical technologies (PAT) and laboratory automation led to a substantialincrease in the volume of data to be captured, processed, and analysed during bioprocessdevelopment. We showcase an E2E structured knowledge management platform that supportsthe entire bioprocess development workflow. The goal of bioprocess development is to generaterobust processes to produce a biotherapeutic at desired quality and scale. We designed a dataplatform applicable to all proteins (e.g., IgGs, ADCs, bispecifics, enzymes), RNA & DNAtherapeutics and vaccines (e.g., mRNA, DNA vaccines, ASOs), and cell and gene therapeutics(e.g., AAVs, CAR-T cells). In close collaboration with groups from leading biopharmaceuticaland biotech companies, we validated the platform’s design for support of complete developmentworkflows. The platform automates cell line development, assesses numerous scale-downupstream processes (USP), manages USP up-scaling, supports downstream process (DSP)development, and facilitates analytical and formulation development. It enables lineage trackingof all intermediates and batches. Analytical and process data, raw materials, equipment details,and molecule and cell line information are automatically tracked with the batches, enablingsystematic assessment, robust process understanding, and quality risk management. Theplatform enhances process and product understanding and control. Having accumulatedstructured data can serve as a powerful foundation for learning, modeling, and data analytics,such as mechanistic modeling, ML and AI, to gain process knowledge and perform predictions.
Genedata | Poster Area | Michele Bruschi |
| 18:10 | POSTERS | A Digital Platform for the Development of Next-Generation Antibody Drug Conjugates (ADCs) and Other Antigen-Targeting Conjugates Poster: 72
Antibody Drug Conjugates (ADCs) use antibodies to achieve targeted delivery of therapeuticcargoes to specific cell populations and tissues. In oncology, ADCs are used to selectivelyeliminate tumors while reducing the off-target effects associated with conventionalchemotherapy. Here, we present how Genedata Biologics® supports and accelerates the fullADC discovery process from antibody screening and engineering to antibody expression,purification, drug conjugation, and reporting of ADC-specific analytics (e.g. DAR, drugdistribution, homogeneity). The platform enables the automated generation, registration, andtracking of large panels of ADC candidates and incorporates results from analytics andfunctional assays in one integrated system, thereby substantially increasing throughput andefficiency of the ADC discovery process. Other next-generation antigen-targeting conjugates,including bi-specific ADCs, alternative scaffolds (e.g. scFVs, DARPins), and novel payloads(e.g. oligonucleotides, antibiotics) are also supported by the system to accelerate the applicationof these new technologies.
Genedata | Poster Area | Ines Boehm |
| Time | Type | Description | Room / Location | Presenter |
| 11:45 | ROUNDTABLE | Automation and AI in Mass Spectrometry Workflows: Hype or Hope?
Genedata | Exhibition Floor | Arnd Brandenburg,Senior Scientific Account Manager Dominik Mertens,Scientific Account Manager |
| 18:10 | POSTERS | Streamlined Automated Workflows for Aerobic and Anaerobic Microbial Screening Poster: 119 Microbial strains underpin innovation across biotechnology, healthcare, and environmental science—driving advances in protein therapeutics, metabolic engineering, and synthetic biology. Yet, conventional manual workflows remain fragmented, introducing variability, contamination risks, and throughput limitations that hinder reproducibility and delay discovery. Here, we present a fully integrated, sterile microbial screening and colony-picking platform that automates plating and streaking, phenotypic colorimetric selection, liquid transfers, and comprehensive data management. By eliminating manual variability and contamination hazards, this solution significantly boosts throughput and ensures robust and reproducible outcomes.
Under sterile aerobic conditions, cultures of Escherichia coli, Klebsiella aerogenes, Candida albicans, and Saccharomyces cerevisiae were processed using an automated system that combines phenotypic colorimetric selection (blue/white and blue/pink for bacteria; green/purple for yeast) with morphology-based criteria (colony diameter, compactness, axis ratio). The platform achieved 95 % pick efficiency and 99 % transfer accuracy, with OD₆₀₀ monitoring confirming zero contamination. Strategic hit picking coupled with data tracking ensured full traceability and eliminated manual errors, thereby supporting robust downstream functional analyses with confidence.
The workflow was further validated in a microbiome study involving gut sample processing under anaerobic conditions. Traditionally, these workflows require extensive anaerobic chamber handling but automation of plating, colony picking, liquid handling reduced protocol complexity and cut turnaround time by up to three days. Enhanced recovery of isolated colonies reduced operator fatigue, and standardized output make this integrated work cell a scalable solution for microbiome research and engineered microbial platforms.
By resolving key challenges in microbial research, this approach delivers reproducible, contamination-free colony isolation and accelerates experimental timelines—empowering scientists to scale discovery with precision.
Molecular Devices | Poster Area | Janet Graystone |
| 18:10 | POSTERS | Determination of sgRNA and mRNA Sequence Identity by Ion-Pair Reversed-Phase Chromatography and High-Resolution Tandem Mass Spectrometry Poster: 142
A sgRNA targeting the BRAC1 and Cas9-mRNA were used as model systems and enzymatically digested to be analyzed by IP-RP chromatography coupled with HRMS. This workflow shows full sequence identification and chromatographic resolution of impurities and Phosphorothioate (PS) diastereomers of sgRNA. Similarly, Cas9-mRNA sequence identification was achieved in 5’-UTR / 3’-UTR regions, 5’Cap, and Poly-A tail, all while revealing partially capped species, deletions, and Poly-A heterogeneity.
Phenomenex | Poster Area | Tran N. Pham |
| 18:10 | POSTERS | Size Exclusion Chromatographic (SEC) Method for Oligonucleotides Using Heated Columns Poster: 144
A prototype size exclusion chromatographic (SEC) column is described and tested for various AAV serotypes. Its pore size, inert particle chemistry, particle size and bio-inert hardware were found to enable highly reproducible separation and recoveries of the AAV monomer and its aggregates and impurities even amongst batches of columns. The percentage relative standard deviations of the peak area, retention time, and % monomer were all < 1%. This performance not only enables the determination of the critical quality attributes in drug substances and drug products but also allows the use of SEC to develop ion exchange and reverse phase LC methods.
Phenomenex | Poster Area | Crystal Holt |
| 18:10 | POSTERS | Native RPLC-HRMS Method Development Approach for the Rapid Characterization of Antibody Drug Conjugates Poster: 143
A method development approach for native RPLC-HRMS allowing rapid, comprehensive characterization, including average DAR value, of a variety of intact ADCs using a new set of RPLC columns will be described. The effect of sorbent polarity and hydrophobicity on the retention and selectivity of individual DAR species in several commercial ADC drugs will be demonstrated.Optimized chromatographic separation and MS identification of all DAR species, including positional isomers, of several ADCs are shown.
Phenomenex | Poster Area | Dr. Juergen Niesser, Ph.D |
| 18:10 | POSTERS | Suitable Size Exclusion Column for Efficient Adeno-Associated Virus Aggregate Analysis Poster: 145
Biozen™ dSEC-7, a chromatographic (SEC) column, is described and tested for various AAV serotype aggregates. Its 700 Å pore size, inert particle chemistry, and applicable particle size(s) are found to enable highly reproducible baseline separation and recoveries of the AAV monomer and its aggregates, even amongst batches of columns, within 10 minutes. The percentage relative standard deviations of the peak area, retention time, and % monomer were all < 1 % with as little as 0.5 µL of sample. This performance enables faster and more accurate determination of AAV aggregates, a critical quality attribute (CQA) in drug substances and drug products, without compromising data quality.
Phenomenex | Poster Area | Dr. Dirk Hansen, Ph.D |
| Time | Type | Description | Room / Location | Presenter |
| N/A | POSTERS | Enhancing protein purity analysis using capillary electrophoresis-sodium dodecyl sulfate (CE-SDS) with native fluorescence detection (NFD) on the BioPhase 8800 system
The integration of NFD into the BioPhase 8800 system introduces a powerful, label-free detection mode that significantly enhances sensitivity, baseline stability, and repeatability across a range of capillary electrophoresis workflows. This presentation highlights the application of NFD in protein therapeutic and viral vector characterization, demonstrating clear advantages over traditional UV detection.
While the BioPhase 8800 system has established a strong track record for consistency and robustness using UV detection in CE-SDS analysis, users often encounter baseline fluctuations that complicate data processing. Additionally, current strategies to analyze low-concentration samples typically require labeling for laser induced fluorescence (LIF) detection, adding complexity and potential variability.
NFD addresses these challenges by delivering a stable baseline and improved sensitivity without the need for sample labeling. In reduced CE-SDS analysis of immunoglobulin G (IgG) controls, NFD provided excellent resolution between non-glycosylated heavy chain (NGHC) and heavy chain (HC) peaks, and good repeatability for migration time and HC/light chain (LC) ratio. In non-reduced CE-SDS, NFD detected lysozyme impurity spiked into the United States Pharmacopeia (USP) IgG system suitability standard down to 0.01%, demonstrating sensitive detection of impurities using NFD.
NFD also demonstrated strong performance in adeno-associated virus (AAV) capsid protein analysis. Comparative studies across two AAV serotypes using UV, LIF, and NFD showed that NFD enables label-free sample preparation, stable baselines, and repeatable quantitation of viral protein ratios. Superior linearity and assay precision further reinforce its value in AAV purity assessment.
Together, these findings establish NFD on the BioPhase 8800 system as a robust, sensitive, and efficient detection mode for protein and viral vector characterization in size-based CE-SDS workflows.
SCIEX | N/A | Dr Stephen Lock |
| N/A | POSTERS | Characterization workflows for CRISPR-Cas9 gene editing products, plasmids, and mRNA drugs on a single capillary electrophoresis (CE) platform
Gene editing is one of the fastest-growing areas in biotechnology and biopharmaceutical research, with CRISPR-Cas9 leading the field as the primary method. A common strategy involves co-delivering single-guide RNA (sgRNA) and Cas9 mRNA to improve genome editing efficiency. However, the significant difference in molecular size between sgRNA (~100 nt) and Cas9 mRNA (~4.5 kb) creates challenges for analytics supporting co-formulation and quality control. Additionally, developing mRNA-based vaccines and therapeutics requires careful evaluation of the quality of plasmid, linear dsDNA templates, and in vitro transcribed (IVT) mRNA. Detecting impurities in these three distinct molecular types is challenging, as each requires high-resolution separation.
This poster presents results in quality assessment of gene editing products and of mRNAs, starting from plasmids, on a single CE platform—the BioPhase 8800 system.
Analysis of the sgRNA and Cas9 mRNA individually using the RNA 9000 Purity & Integrity kit with capillary gel electrophoresis and UV detection (CGE-UV) indicated high purity for both samples. Simultaneous analysis of the sgRNA and the Cas9 mRNA at different ratios demonstrated an outstanding correlation between the theoretical and the measured ratio of the sgRNA to Cas9 mRNA, with an R2 value of 0.9997. Therefore, this workflow enables a reliable assessment of the ratios of sgRNA and Cas9 mRNA, a critical quality attribute (CQA) impacting the efficacy of the final co-delivered CRISPR-Cas9 product.
Automated, effortless plasmid purity assessment with the DNA 20 kb Plasmid and Linear kit and pre-assembled bare-fused silica (BFS) cartridge on the BioPhase 8800 system generated results with high resolution of plasmid isoforms and excellent repeatability using CGE-LIF (CGE with laser-induced fluorescence detection). Accurate, high-resolution sizing during the purity assessment of the linear dsDNA template demonstrated the capability of detecting near full-length impurity with truncations that may otherwise go unnoticed. High-resolution RNA analysis enabled the separation of mRNAs with different tail lengths and the detection of tailless impurities. Our results revealed that high plasmid purity alone was not enough to ensure the quality of the IVT mRNA. A thorough characterization of the linearized dsDNA template before IVT mRNA production is also necessary to ensure the quality of the final IVT mRNA product.
Overall, these assays demonstrate that the BioPhase 8800 system is a valuable tool for the analysis of gene editing products, plasmids, and mRNA vaccines and therapeutics.
SCIEX | N/A | Dr Stephen Lock |
| N/A | POSTERS | In-depth charge heterogeneity analysis of antibody-drug conjugates with a streamlined icIEF-UV/MS and EAD-based peptide mapping workflow
This poster demonstrates the unique capabilities of imaged capillary isoelectric focusing (icIEF)-UV/MS and electron activated dissociation (EAD)-based peptide mapping workflows for rapid charge heterogeneity analysis and comprehensive characterization of a GlyCLICK®-generated antibody-drug conjugate (ADC).1 These orthogonal, streamlined workflows provide multi-level information about product quality attributes (PQAs) of ADCs, facilitating important decision-making early in the development pipeline.
SCIEX | N/A | Dr Stephen Lock |
| N/A | POSTERS | Enhanced sensitivity of intact LC-MS approaches to expand the capability of biotherapeutic analysis with a novel QTOF
Sensitive detection and accurate mass measurement of intact proteoforms or impurities are essential for the comprehensive analysis of new-generation biotherapeutics with increasing complexity to ensure product quality and safety. This poster describes an enhanced intact mass spectrometry (MS) workflow with increased sensitivity for accurate mass measurement of biotherapeutics and their proteoforms. The advancements in the ion source, optics and detectors of a novel QTOF system led to superior detection of intact biotherapeutics and impurities with reduced sample consumption compared to the older platform.
SCIEX | N/A | Riccardo Rubbiani |
