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Bioassay to review potency testing choices at Basle Festival of Biologics
Heidelberg, Germany: – Specialist bioanalytical contract research organisation (CRO) Bioassay GmbH will present an expert review of the options facing drug companies that need to test the potency of their products when it addresses the upcoming Festival of Biologics in the Swiss city of Basle in mid-October.
Basle is the center of Switzerland’s huge life sciences cluster and the meeting will provide a highly influential audience of R&D professionals for whom potency testing is a daily concern.
Potency assay options
Bioassay’s Head of Assay Development & Validation, Dr. Patrick Mäder, will address the festival to provide an expert CRO laboratory perspective on the assay options needed to characterize biological products.
His Day Three talk on the topic of ‘Ready-to-Use Kits for GMP Potency Assays: Buy the Kit and Release the Sample?’ (October 12: 1200 hrs) will form part of the conference track on Analytics, Screening and Immune Repertoire Technologies.
Dr. Maeder will establish that potency assays are typically the most customized and unique type of all the tests found for batch release purposes on biologic products and that, unlike safety, purity, or other tests, potency assays must be directly related to the biological activity and reflect the mode of action of the biological entity. These stipulations require that development, characterization, and validation efforts are started early in the lifecycle of the product with adequate resources and know-how being allocated to support assay development and validation most efficiently.
How useful are potency kits?
Dr. Mäder will review the advent of numerous ready-to-use bioassay kits that have entered the market over recent years to assess potency following standardized protocols and will discuss the advantages of partnering with a contract research organization specialized in developing, validating, and releasing bioanalytical methods.
Dr. Patrick Mäder also heads the in chemico Department (HPLC) at Bioassay GmbH (Heidelberg, Germany and has a wealth of experience in all aspects of development and validation applications of in vitro and in chemico potency assays in achieving GMP and GLP compliance.
Bioassay will be an exhibitor at the Festival from stand 905 in Hall 1 of the Basle Messe, and will also be represented at the Festival by its CEO, Dr. Sebastian Dempe, CSO Dr. Axel Hohenstein, and Business Development Director, Dr. Luisa Duque.
The Bioassay team will take advantage of the festival’s networking opportunities to present advantages of its mRNA vaccine development and validation platform, developed to support testing of the new generation of messenger RNA vaccines as well as new application opportunities for its extensive portfolio of functional bioanalytical assays for biopharma sitting alongside its specific peptide synthesis and analysis services.
Dr. Hohenstein commented: “The Festival of Biologics has become one of Europe’s most essential annual events in the field of advanced biotherapies and this provides us with the perfect arena in which to showcase our industry-leading expertise in specialized assay development to ensure rigorous quality control of biological products.”
About Bioassay GmbH
Bioassay GmbH is a bioanalytical contract laboratory (CRO) specializing in the development, validation and routine performance of bioanalytical assays in the areas of Pharmacology and Toxicology.
Bioassay serves clients in the biotechnology, chemistry and cosmetics sectors and is particularly expert in carrying out potency assays under GMP for biopharmaceuticals, including therapeutic antibodies, hormones and cytokines. It offers a range of services based on in-vitro and in-vivo systems including potency assays (GMP) and toxicity studies (GLP).
The Bioassay services portfolio focuses on the critical investigation areas of potency, efficacy, and safety, with panels that incorporate a wide range of specialized models and techniques.
Bioassay GmbH was privately founded in 2002 and since 2022 has formed part of the Reaction Biology Corporation. The company is located at Heidelberg’s Technology Park as part of a cluster of innovative biotech companies and institutions with links to Heidelberg University.
Learn more at: https://bioassay-online.com
About Festival of Biologics 2023
The Festival of Biologics hosted annually in Basel, Switzerland, has become one of Europe’s most compelling events for reviewing the latest developments in bringing new leading-edge therapies to market.
The conference brings together academics, research institutes and leading commercial players to share their experiences, create new partnerships and tackle the clinical trials, manufacturing and commercial challenges involved in biological therapies. Multiple conference tracks focus on specialist areas such as drug discovery, development, clinical trials, manufacturing, pricing and market access.
The 2023 Festival is a three-day event opening October 10 in Hall 1 of the Messe conference center in Basel. It is expected to attract more than 2,500 attendees, some 150 exhibitors and will feature more than 350 speakers.
The event is organized by Terrapinn with further information at: https://www.terrapinn.com/conference/festival-of-biologics/index.stm
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