Challenges and Solutions in Host Cell Protein ELISA Development

Life Sciences, Pharma Manufacturing & Supply Chain,
  • Thursday, November 19, 2020

Host Cell Proteins (HCPs) pose a common challenge to biopharmaceutical manufacturers as residual HCP can negatively influence the quality, safety and efficacy of drug products. The stepwise Downstream Processing (DSP) aims to purify the drug substance and requires the reliable monitoring of potential HCP impurities. This is usually carried out by an HCP ELISA as the method of choice, enabling an HCP measurement down to low ppm level. This method is based on antibodies that specifically detect HCP species in user-defined DSP samples which contain the drug substance. During ELISA development at BioGenes, a list of critical aspects is used to generate a powerful HCP assay. This includes the correct choice of a suitable mock antigen, a sophisticated immunization strategy, comprehensive reagent characterization, and a targeted ELISA set-up.

In this webinar you will learn about:

  • The similarities and differences between generic and specific HCP ELISA formats, and when to use them
  • The importance of selecting suitable antigen material and optional fractionation
  • Powerful polyclonal antibody generation, including the surveillance of proper immune reaction, adjusted purification strategy, and cross-reactivity testing
  • Orthogonal methods for sample/reagent characterization (2D DIGE, 2D Western Blot, Immunoaffinity Chromatography)
  • How BioGenes implements relevant process samples in ELISA development to increase assay robustness

Speakers

Stefan Sommerschuh, BioGenes

Stefan Sommerschuh, Head of Assay Development, BioGenes

Stefan Sommerschuh received his Diploma in Biotechnology from the University of Applied Sciences (TFH) Berlin, with a focus on bioprocessing. For his diploma thesis at Strathmann Biotec in Hamburg, he worked on the downstream process development of recombinantly-expressed proteins. Stefan joined BioGenes in 2007 as a scientist in charge of immunoassay development. In 2014, he became the head of the immunoassay department, responsible for leading scientific projects. Stefan has expertise in HCP assay development, including reagent characterization, antibody purification and ELISA optimization. He also supervises all aspects of analytical method qualification/validation, according to the established guidelines.

Message Presenter
Marieke Tesch, Biogenes

Marieke Tesch, Marketing & Sales Manager, BioGenes

Marieke Tesch received her diploma degree in Biology from the university of Tuebingen with specialization in immunology, human physiology and human genetics. During her subsequent PhD thesis and postdoctoral studies at the Institute of Immunology and Experimental Oncology of the University of Witten/Herdecke, she further deepened her knowledge in the field of cancer research. 

The PhD program that she attended was one of the first that promoted the collaboration of physicians and natural scientists to foster biomedical research. For her last postdoctoral position, she joined the Massachusetts General Hospital in Boston as a postdoctoral research fellow of the Harvard University to conduct research on antibody- and CAR T cell-based immunotherapy for the treatment of various tumor diseases. Since 2017, she has been a Marketing / Sales Manager at BioGenes.

Message Presenter
Dr. Martin Föge, BioGenes

Martin Föge, PhD, Business Development Manager, BioGenes

Martin Föge received his diploma in Biology from the University of Greifswald, Germany, with specialization in Microbiology, Virology and Biochemistry. Following this, he became a member of the PhD graduate academy at the Jena School for Microbial Communication with a stipend for his doctoral thesis at the Leibniz Institute for Natural Product Research and Infection Biology (HKI Jena, Germany). After the successful completion of his PhD, he used his expertise on human-pathogenic fungi in a post-doctoral position at the University Clinics Jena, Germany. Here, he focused on the investigation of the impaired innate immune response of cancer patients to deadly fungal infections by using a variety of immunological and molecular biological methods.

To complement his scientific skills, Martin then completed a training program in Life Science Management, including key aspects of Marketing, Project Management, Regulatory Affairs Management and Drug Development, before joining BioGenes in 2018. After starting in the position of Marketing Manager, he has recently established himself as Business Development Manager at BioGenes, linking scientific and technical advancements, and the identification of customers’ demands for high-quality services.

Message Presenter

Who Should Attend?

This webinar will be relevant to those in the biotech, bioprocessing, pharmaceutical and biologics contract manufacturing (CMOs) industries.

This includes directors, managers, scientists, group leaders and laboratory heads interested in:

  • Immunology
  • Proteins
  • Antibodies
  • Drug Safety
  • Vaccines
  • Assay Development
  • Quality Control
  • Downstream Processing
  • Bioanalysis
  • Bioassays
  • Analytical Science

What You Will Learn

Join this webinar to learn about:

  • The similarities and differences between generic and specific HCP ELISA formats, and when to use them
  • The importance of selecting suitable antigen material and optional fractionation
  • Powerful polyclonal antibody generation, including the surveillance of proper immune reaction, adjusted purification strategy, and cross-reactivity testing
  • Orthogonal methods for sample/reagent characterization (2D DIGE, 2D Western Blot, Immunoaffinity Chromatography)
  • How BioGenes implements relevant process samples in ELISA development to increase assay robustness

 

Xtalks Partner

BioGenes

BioGenes is a full-service provider of customized immunoassay and antibody development, with a strong commitment to quality and service.

Founded in 1992 and headquartered in Berlin, Germany, BioGenes is a recognized partner serving more than 600 customers in 40 countries. The company maintains long-term relationships with CMOs, global pharmaceutical, biotech and diagnostic companies.

BioGenes provides highly customized solutions for the quality control of biological products, from drug discovery and drug development to the manufacturing of biologicals, as well as for diagnostic purposes.

The company has a proven track record in the development, qualification, pre-validation and production of highly sensitive and robust ELISAs and host cell protein (HCP) assays. Furthermore, BioGenes specializes in sophisticated custom monoclonal, polyclonal and anti-idiotypic antibody development for several purposes.

 BioGenes offers a panel of enhanced generic 360-HCP ELISA kits and supports customers with a comprehensive range of analytical services, e.g. 2D analysis and coverage determination of HCPs.

 

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