Rapid At-Line Antibody Titre Determination Using the MININEPH Endpoint Nephelometer

by Kym Baker, PhD, Leanna Jones, Alison Smith, PhD, Hilary Harrop, PhD, and Steve Flatman, PhD
Volume 5, Issue 2 (Summer 2006)

One of the major aims of modern biotechnology companies that are producing recombinant therapeutic proteins is to focus on timeline reduction of critical cell line selection and process optimisation studies in order to minimise the time and financial constraints of early development products. This “minimalist paradigm” of maximising early development throughput with minimal capital/operational outlays is a key driver for implementation of novel analytical technologies which can be applied at-line to process instrumentation. The large-scale production of recombinant therapeutics in the biopharmaceutical industry relies on in-process monitoring of product titre. Traditional titre determination methods, including enzyme-linked immunosorbent assay (ELISA) and protein A high performance liquid (immunoaffinity) chromatography (Protein A HPLC), are time consuming, and often reliant on analytical support from separate specialist teams/departments requiring detailed scientific knowledge and extensive training, with expensive capital outlay utilising large equipment…

Baker K, Jones L, Smith A, Harrop H, Flatman S. Rapid At-Line Antibody Titre Determination Using the MININEPH Endpoint Nephelometer.BioProcess J, 2006; 5(2): 71-77. https://doi.org/10.12665/J52.Baker