Antibody Engineering for Pursuing a Healthier Future

Saeed, Abdullah F. U. H.; Wang, Rongzhi; Ling, Sumei; Wang, Shihua

The optimal conditions such as temperature, percent carbon dioxide, and humidity for cell cultures should be determined (Sen and Roychoudhury, 2013) , and then transferred to a pilot scale for scalability and toxicology studies. In addition, clinical materials should be produced on a large scale under the existing good manufacturing practice (cGMP) regulations. After production on a small scale, products that are already cultured in a laboratory are then transferred to pilot scale commercialization. The process then performs characterization, scaling, technology transfer, and validation. Commercial cell culture for the production of a biological product is completed by pilot scale laboratory methods . Recently, commercialization is initiated by process characterization, scaleup, technology transfer, and validation of the manufacturing process (Li et al., 2006) . ELISA is enzyme-based colorimetric assay, requires large sample volumes, several incubation steps and has low detection sensitivity (Tang and Hewlett, 2010) . Conversely, nanotechnology and nanoparticles (NPs) use nanomaterials with length scale of 1-100 nanometers (nm). Nanomaterials have unique biological properties such as small size, large surface-tovolume ratio, sharp melting temperature, magnetic properties, unusual target binding properties, and size based multi-coloring (Qi and Wang, 2004) . NPs such as gold particles have been used to improve assay sensitivity and specificity of antibodies, low limit of detection (LOD), dose response over 10,000-fold and the detection sensitivity by 1,000-fold compared to ELISA (Tang and Hewlett, 2010) .