|Automated Solutions for Cellular Screening and Characterization of Therapeutic Antibodies for Antibody-Dependent Cellular Cytotoxicity Utility|
Brad Larson, Peter Banks , Nicolas Pierre, Stéphane Martinez, and Francois Degorce
Since the end of the 1990’s, the pharmaceutical industry has seen an increased interest in biologics, especially in the therapeutic areas of oncology and inflammation. Here we present the automation of two assays for the characterization and selection of potent antibody drug candidates. Both assays rely on HTRF® detection. The first assay quantifies the binding affinity of antibodies to their target antigen, on live cells.
|Validation of an Automated Cell-Based Bioluminescent TNFa Blocker Bioassay|
Brad Larson, Tracy Worzella, Rich Moravec, Neal Cosby, Frank Fan, Teresa Surowy and Peter Banks
TNFa blocker biopharmaceuticals represent an important and successful class of protein drugs used in the treatment of several autoimmune diseases. Bioassays are indispensible tools in biopharmaceutical drug development and commercialization that are used to quantify biological activity and stability of drugs or drug candidates. The automation of these assays can serve to create an accurate, robust process which can allow the researcher to perform other more important functions.
|Improving Cell-Mediated Cytotoxicity Assessment through the Use of an Automated Luminescent ADCC Assay|
Brad Larson, Sumant Dhawan, Shalini Wadwani, and Peter Banks
Assays that can assess the ability of a biosimilar to act in a manner similar to the original biologic have seen increased interest. This poster describes the use of a non-radioactive luminescent chemistry to simplify the assay process and provide improved data quality.
|Antigen Determination in Autoimmune Hepatitis Type1|
Naveen L Gupta, S Nayak, S Shakeyavar
Objectives of this project were to exploit the database in indian setting to determine nuclear antigens as target for antinuclear antibodies (ANA) in patients of autoimmune hapatitis (AIH) type1.
|Biopharmaceuticals Hiding in the Woods|
Prof. Rodney Savidge
Suggestions are provided of how efficient industrial bioprocessing can be accomplished, independently of highly expensive molecular biology approaches, in order to recover natural products of medicinal value from wild plant species.
|A Mix-and-Read Cell-Based Assay for Antibody Screening Against Epidermal Growth Factor Receptor|
Wayne Bowen, David Onley, Tristan Cope
The conventional antibody screening assay based on antibody-antigen binding has been enzyme-linked immunosorbent assay (ELISA). While tedious and consuming, ELISA has proved sufficient for the identification of antibodies directed against secreted antigens. However, cell surface antigens (e.g. GPCRs) provide challenges for ELISA due to the shortage of soluble antigens and high variability resulting from loss of cells during wash procedures.
|Facing the challenges in bio-pharmaceutical production: newly developed polymer-based ion exchange chromatography media and their application to the purification for Immunoglobulin – from egg yolk|
Masakatsu Omote, Noriko Shoji, Naohiro Kuriyama and Daniel Kune
Much attention has been given to ion exchange (IEX) media as a means to improve productivity as a result of increasing demand for higher efficiency on the downstream process. Until recently, strain optimisation for high productivity and upstream purification were the bottlenecks for most bio-processes.
|Development and NDA-Level Validation of a Real-Time PCR Procedure for Detection and Quantification of Residual E.coli DNA Contamination of Biopharmaceutical Products|
Dan Papa, Pedro J. Morales and Michael D. Sadick
Escherichia coli (E. coli) has been commonly used for the production of biopharmaceuticals. Among the impurities that must be monitored in biopharmaceuticals is residual host-cell DNA (HCD). This study describes the development and subsequent NDA-level validation of a real time PCR procedure developed in response to a client’s need to improve the sensitivity of detection and quantification of residual E. coli HCD in their drug product.
|Hepatitis B virus (HBV) and Human immunodeficiency virus (HIV) antibodies detected by peptide microarrays|
ahmed Abd El Wahed1, Ulrike Beutling2, Ronald Frank2, Gerhard Hunsmann1, and Hans-Joachim Fritz3
HBV and HIVenv chips with overlapping oligopeptides encompassing the full amino acid sequences of HBV and HIV polypeptides were produced. In addition, a chip displaying a library of random 4608 different 15-mers peptides (4608-RPL) was prepared. Both chips were used for analyzing monoclonal antibodies and sera from HIV- and HBV-infected individuals. 4608-RPL could be used for identifying target sequences of antibodies without prior knowledge of the corresponding immunizing antigen.
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