Therapeutic biologics derived from proteins are generally less prone to untoward effects than small molecular entities derived from chemical synthesis. Big pharmaceutical companies are venturing into biotechnology arena with the hope that novel therapeutic biologics will fundamentally reshape the pharmaceutical landscape. Several major companies have projected that therapeutic biologics will comprise a majority of their commercial portfolios in the future.

We specified in two major technology fields to cater your needs in biologics drug research and development: ELISA and mass spec-based technologies.

ELISA: Enzyme-linked immunosorbent assay (or enzyme immunoassay, EIA) is a biochemical technique used to detect the presence of an antibody or an antigen in a sample. In ELISA, an unknown amount of antigen is coated to a surface, and then a specific antibody is flowed over the surface so that it can bind to the antigen. This antibody is linked to an enzyme, and in the final step a substance is added that the enzyme can convert to detectable signal. For example, a colorimetric assay, currently the mostly used ELISA format, results in a colored reaction product that absorbs light in the visible range. The optical density of the reaction product is typically proportional to the amount of analyte being measured.

We have well-established ELISA lab and our scientists are experienced in ELISA assay development. To complete your research project, we will either use commercially-available ELISA kits, or develop a new ELISA kit if such kit is not commercially available.

Mass spec based technologies: Immunoassays, although sensitive, lack the necessary selectivity for distinction between proteins and their metabolites. Modified molecules induced by metabolic transformations such as truncations might not be differentiated by the antibody used in the assay, leading to cross-reactivity. As an alternative, various types of mass spec have been used extensively in characterization and quantification of biologics drugs. In the last several years, a new mass spec-based quantification method, MRM (multiple reaction monitoring) has been used in quantification of biologics. MRM bypasses the needs to generate antibody, and has the advantage of multiplexing, since multiple proteins/peptides can be monitored during a same LC-MS analysis. MRM could save valuable time and resources in early studies of biologics when antibodies across different animal species are not readily available.

Our high end mass spec portfolio includes Thermo LTQ and OrbiTrap, MALDI-TOF/TOF for protein/peptide characterization and two sets of LC-MS (API4000 triple quad) for biologics quantification.

Some of the services on biologics we current provide are:

• Biologics characterization
• Assay and process development and validation
• Quantification of biologics
• PK/PD analysis

We will work with you to develop a plan to address your research and development needs for your biologics while make sure that your cost is under control. Please feel free to contact us to get started.