Molecular diagnostics are a collection of fast, highly specific, accurate and cost effective techniques to analyze biomarkers both in the genome and the proteome. It uses biological assays such as the Enzyme-linked immunosorbent assay (ELISA) and Fluorescence in situ hybridization (FISH) among others, to detect molecular markers which are associated with a specific disease. Monoclonal antibodies (mAbs) play an important role in all of these molecular diagnostic techniques because of their high specificity towards specific antigen and almost unlimited production. Moreover, mAbs can be particularly produced and designed to any antigen. For a significant length of time, mAbs are manufactured via in vivo production in mice however due to ethical concerns and the need for mAb mass production a demand for high density in vitro production of monoclonal antibodies arises. Bioreactors that can generate high yields of mAbs have been manufactured. However, these bioreactors only allow one mAb production at a time, costly and prone to contamination. Molecular diagnostics can be categorized into three types, In vitro diagnostics, In vivo diagnostics and Disease diagnostics
*In Vitro Diagnostics (IVD) – are a collection of tests that are used to detect infections, diseases, allergies and other medical conditions. Most IVD tests are performed in the laboratory or professional healthcare clinics. The applications of IVD in medical diagnosis are vast and includes disease detection, regenerative medicine monitoring and tests of blood for transfusion. One technique which is widely used in IVD is the Sandwich ELISA which is a type of ELISA that uses two layers of monoclonal antibodies to quantify antigens. In this type of system the mAb act as either the capture or detection antibody.
*In Vivo Diagnostics – In vivo diagnostic, in general, is a methodology that is done in the body to detect diseases or medical conditions. The objective is for the in vivo biologic introduced in the body to elicit an immune response. The immune response will then be quantitated and observed if it is a conclusive determinant of the disease.
*Disease Diagnostics – Molecular bioassays are used for disease diagnostics. Some of the widely known and proven techniques to diagnose diseases are western blotting, immunofluorescence, and ELISA.
Western blot is an assay for the detection of specific proteins from a sample. Target specific monoclonal antibodies are utilized to complex with an enzyme which attaches to the transferred protein. This technique is used in a wide range of medical diagnosis applications such as for HIV infection, bovine spongiform encephalopathy (BSE), Feline immunodeficiency virus (FIV), Hepatitis B and so on.
Immunofluorescence is a technique which determines the location of an antibody or an antigen from a sample by reacting it with another antigen or antibody, respectively, which is labeled with a fluorescent dye. This technique can be used in the diagnosis of different diseases like Systemic Lupus Erythematosus (SLE) and Primary Ciliary Dyskinesia. Also, it can be used to measure the body’s quantity of antibody against different kinds of microorganisms like Coxiella burnetti, which causes Q fever to both humans and animals, and Rickettsia which causes the Colorado tick fever.
Enzyme-linked immunosorbent assay (ELISA) is an immunological technique which detects and quantitates the amount of antibodies, antigens, or proteins in a given sample. The applications of ELISA in medical diagnostics is vast because of its proven effectivity. ELISA are used in various veterinary diagnostics tests as well as in human diagnostics for the diagnosis of allergies, infectious diseases, and even cancer.
These molecular diagnostic techniques greatly rely on the use of highly specific and highly efficient antibodies to give out accurate and precise results. Hence, a standard, stable and highly reproducible method for the mass production of the desired antibody must be of primary concern.
The VacciXcell Solution:
Esco VacciXcell offers a wide range of bioreactors that can produce high yields of mAbs from hundreds of milligrams to grams. Celcradle™ is a disposable bioreactor capable of high- density cell culture for protein expression, virus and monoclonal antibody production. It is designed based on the concept of the bellow-induced intermittent flow of media and air through porous matrices, where cells reside. This provides a low shear, high aeration, and foam-free culture environment. For each run of the equipment it can produce four different types of mAb which greatly cut production costs. The bioreactor also features a disposable and fully enclosed matrix vessel which significantly lessens the bioreactor's proneness to contamination. Lastly, VacciXcell's bioreactors boast of its true linear scalability platform where production scale up is as easy as adding equipment but the bioprocessing principles are the same.