Enzyme ImmunoAssay (EIA) is a technique to detect and quantify antigens (proteins, hormones…) or antibodies in samples. It relies on the ability of an antibody to bind a specific antigen. Either the antibody or the antigen is labelled with an enzyme wh...More
PRODUCT EXPLANATION: HCP
US Pharmacopeial Convention. Residual Host Cell Protein Measurement in Biopharmaceuticals. HCP IMMUNOASSAY METHOD VALIDATION/4.3 Sample Linearity/Table 4 - Second Supplement to USP38-NF33 p. 7647 1st April 2016
Tscheliessnig AL. et al. Host cell protein analysis in therapeutic protein bioprocessing methods and applications. Biotechnol J. 2013, 8(6):655-70
Wang X et al. Host cell proteins in biologics development: Identification, quantitation and risk assessment. Biotechnol Bioeng. 2009, 103(3):446-58
PRODUCT EXPLANATION: KIT DEVELOPMENT
Valentin MA, Ma S, Zhao A, Legay F, Avrameas A. Validation of immunoassay for protein biomarkers: Bioanalytical study plan implementation to support pre-clinical and clinical studies. J Pharm Biomed Anal. (2011) 55(5): 869-877
European Medicines Agency. Guideline on bioanalytical method validation, 21 July 2011
SPI-Bio is a brand name of Bertin Bioreagent.
Bertin Bioreagent includes over 100 employees, chemists, biochemists, immunoanalysts, pharmacists and technicians.
Always at the forefront of innovation and after launching on the market products incorporating in their time innovative technologies (Acetylcholinesterase tracer for EIA), this brand offers a wide and unique range of assays for biomarker Immunoassays (SPI-Bio TM) thanks to a solid knowledge acquired during the last 25 years in developping over 100 biomarkers assays.
To better serve you, we aim to design our products and reagents to address your needs on the expected performance in terms of a possible range of use, but also on operational conditions of use & regulations.
Thanks to our production processes and quality controls, we provide you with products with compliance to specifications.
Our technical support & science teams are available to help you assess their relevance depending on your needs, to specify the conditions of application and their fields of use. Finally, our researchers are ready to provide you with the necessary support by going, if needed, in your laboratories to validate your operating conditions and to solve possible problems.