Eurofins BioPharma Product Testing (BPT) Germany is excited to participate in the 17th Annual Hybrid European Bioassay Conference, taking place from September 25-27, 2024, in Prague, Czech Republic. This leading event is a key gathering for professionals in the analytical biopharmaceutical field, featuring three days of presentations, workshops, and round-table discussions.
Event Details:
Date: September 25-27, 2024
Location: Hilton Prague Hotel, Prague, Czech Republic
Join us on September 27 at 16:15 for our presentation:
Title: From Manual to Automated: Case Studies for Increasing Bioassay Precision and Throughout by Adding Modular Components in Bioassay Workflow
Speaker: Dr. Frances Reichert, Technical Specialist Biologics, Eurofins BioPharma Product Testing Germany GmbH
Abstract: For Quality Control (QC) of biopharmaceuticals, release of batches and stability assessments require in vitro cell-based (bio-)potency assays (CBA). These assays inherit intrinsic variability, primarily due to the use of living cells and factors like pipetting steps, assay complexity, and analyst experience. Despite advances in automation, implementing full automation remains challenging in a GMP environment. We focused on semi-automation of potency assays in a modular manner, automating specific parts of the assay. This presentation will showcase several case studies demonstrating how modular workflow automation can enhance the reliability, precision, and throughput of potency assays.
Join us on September 26 at 13:00 for the Luncheon Talk:
Title: Moving the Scale for Biotherapeutics from Bench to Bedside: Developing Qualified Cell-based Assays
Speakers: Dr. Bettina Katterle of Eurofins BioPharma Product Testing (Munich) & Gaurav Agrawal, Ph.D. of Eurofins DiscoverX
Abstract: Here we present the development and qualification of cell-based assays using FACS, (semi-) automation methods for testing of biotherapeutics, ATMPs, and peptides. Case studies for Tirzepatide, a global blockbuster weight-loss agent that engages GLP-1 and GIP receptors will be shown. Recently approved peptide therapeutics such as Semaglutide and Tirzepatide targeting GPCRs have demonstrated remarkable efficacy in managing obesity, type 2 diabetes, and an expanding range of associated conditions. To effectively develop these innovative drugs, as well as their biosimilar and biobetter derivatives, pharmacologically relevant assays are essential. These assays are crucial for understanding the precise mechanism of action, and establishing desired pharmacological profile, in addition to ensuring reliable measurements.