Biotechnology services modify living microorganisms to provide biotechnology products on a contract or custom basis to medical, pharmaceutical, and scientific laboratories. These biotech companies may specialize in either monoclonal or polyclonal antibody development, or provide a full range of biotechnology services. Monoclonal antibody development is used in the development of assay reagents for drug discovery. By identifying important genetic biomarkers, pharmaceutical companies can develop products for therapeutic applications more quickly. Polyclonal antibody production services are also used by pharmaceutical and diagnostic companies. Biotechnology companies that perform monoclonal or polyclonal antibody development must comply with a range of regulatory requirements.
Some biotechnology services perform in-vitro monoclonal antibody purification. This technique involves the expansion and preservation of hybridoma cell lines in multiple vials, media preparation and quality control (QC), the regular collection and storage of supernatants, and supernatant concentration. Monoclonal antibody purification services may also specialize in the sterile filtration of the final product. There are three main antibody protocols for biotechnology services: the immunoblotting basic protocol, western blotting for chromagenic and chemiluminescent detection, and the basic ELISA protocol. ELISA, an acronym for enzyme-linked immunosorbent assay, is a laboratory test to determine the presence of the human immunodeficiency virus (HIV) in the blood.
To validate the performance of purified antibodies, biotechnology services may use several different diagnostic tools for antibody characterization. These diagnostic tools include size exclusion chromatography (SEC) and isoelectric focusing (IEF). SEC allows biotechnology services to determine an antibody’s percent purity. This technique also lets biotechnology companies calculate and differentiate various aggregated and fragmented percentages. IEF is used to determine the isoelectric point of an antibody, a value that corresponds with the antibody’s pH. By using IEF, biotechnology services can also reveals variants in the genetic material.
Biotechnology services may specialize in specific biomolecules such as recombinant proteins, vaccines, blood products, and gene therapy products. Recombinant proteins are used in the prevention and treatment of many diseases and medical conditions. Vaccines are immunogens that are administered to stimulate the body’s production of antibodies and provide immunity against a disease. Blood products are used in the donation and collection of blood. Gene therapy services insert genes into a subject’s cells and tissues to treat a disease. Some biotechnology services use this experimental technique to inactivate a mutated gene that functions improperly, or to replace an unhealthy gene with a healthy copy of one.
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