Bioprocessing Summit Europe 2024

Structured data provides the foundation of biopharma data landscapes because it enables efficient application of analytical tools and machine learning algorithms and usually allows more streamlined decision-making than unstructured data. Both sponsors and regulatory agencies need structured data to make decisions and are undergoing digital transformations to facilitate exchange of such data. During R&D, sponsors typically utilize highly fragmented data systems—such as combinations of electronic lab notebooks (ELN), laboratory information management systems (LIMS), and data lakes—to accumulate both structured and unstructured data. This makes tracking and sourcing structured data for transfer to regulatory agencies challenging. We will discuss the technical innovations that enable structured CMC data capture, analysis, and transfer, with special focus on commonly used technologies such as mass spectrometry (MS), chromatography, and next generation sequencing (NGS). We will also discuss special requirements of new biologic modalities such as antibodies, bi- and multispecifics, cell and gene therapies, and RNA.

A Streamlined Workflow for Analytical Characterization of Antibodies
Isabel Kolinko | Genedata, AG, Basel, Switzerland
Track C6A: Analytics and Characterisation

Assays for protein quantification and purity assessment are a routine and critical part of any antibody discovery and development workflow, including for bispecific antibody (bsAb) formats. When developing bsAbs using their DuoBody^® platform, Genmab performs such assays on a regular basis following batch production and purification of lead parent molecules and post Fab-arm exchange. Previously, Genmab analyzed their protein production assays using a combination of instrument software and Excel macros, leading to a lack of data traceability and high maintenance burden. Genedata Screener^® was implemented to automate the analysis of these highly standard assays, including A280 quantification, Octet quantification, and hydrophobic interaction chromatography (HIC)/cation exchange chromatography (CIEX). Furthermore, Screener integrated with Genedata Biologics to form an assay cascade in which results from the A280 assay were seamlessly reported, then later retrieved along with other key molecule properties for result calculation during analysis of the same protein batches using different assays.

Unlocking Opportunities in ATMP Development: NGS for Starting Material, Product Characterization and Release Testing in a GMP Environment
Sarah Berger | Genedata AG, Basel, Switzerland
Track C3A: Gene Therapy CMC and Analytics

ATMPs (Advanced Therapy Medicinal Products) hold great promise as a new class of medicines for treating a variety of diseases. However, their development and production present significant challenges, including complex vector design, the need for high-quality cell lines, and stringent regulatory compliance. Genedata Selector^®, an enterprise software platform, addresses these challenges by enabling rapid and comprehensive analysis of next-generation sequencing (NGS) data to select, characterize, and optimize the producer cell lines and viral vectors. The platform enables screening for factors such as genetic stability, transduction efficiency, expression level, and quality control markers. By harnessing the power of NGS technology, Genedata Selector automates the critical quality attributes (CQAs) testing of ATMPs, such as identity, purity, potency, and safety. With this, biopharmaceutical companies can produce high-quality ATMPs that meet both good manufacturing practice (GMP) requirements and clinical standards, reducing both the time-to-market and development costs.

An Integrated, Enterprise Software Solution for In-Depth Characterization & Quality Monitoring of Biopharmaceuticals
Malwina Michalak | Genedata GmbH, Munich, Gemany
Track C6A: Analytics and Characterisation

Mass spectrometry (MS) has become a key analytical technology throughout the entire biopharmaceutical lifecycle, from in-depth characterization of biotherapeutic candidates during discovery and development, to quality monitoring of drug products during manufacturing. By providing a single, scalable solution for all MS data analysis, processing, and reporting while seamlessly integrating into existing analytical processes, the Genedata Expressionist^® enterprise software platform accelerates and streamlines biotherapeutic development across entire organizations.

End-to-End Workflow Platform for Integrated Biopharmaceutical Development
Wen Clifford | Genedata Ltd., London, UK
Track C6A: Analytics and Characterisation

The increasing number of biopharmaceutical development projects, combined with the application of more and more high-throughput technologies in cell line and bioprocess development, has led to a significant increase in the amount of data to be captured, processed, and analyzed. Genedata Bioprocess^® is an E2E platform co-developed in close collaboration with leading biopharmaceutical companies that supports the entire bioprocess development workflow. The platform not only fully automates cell line development and assessment of scale-down upstream processes (USP), it also manages USP up-scaling, downstream process (DSP) development, as well as analytical and formulation development. It enables the lineage tracking of all batches, starting from the transfection of a cell line through to the vials containing the final drug substance and drug product. Analytical and process data, together with raw material and equipment details and molecule and cell line information, are related to these batches, enabling the systematic assessment, at any stage, of cell lines, raw materials, processes, and molecules — all in one platform. The platform can be applied to therapeutic proteins (IgGs, ADCs, bispecifics, enzymes), RNA & DNA therapeutics and vaccines (mRNA, DNA vaccines, ASOs), and cell and gene therapeutics (AAVs, CAR-T cells). It directly integrates with instruments, such as pipetting robots, bioreactors, control systems, and bioanalyzers. The platform’s query and reporting infrastructure enables integrated, informed decision-making throughout the process development workflow and comprehensive learning across different development campaigns and molecules.