Process Development for Monoclonal Antibodies

One way the body's immune system attacks foreign substances is by making large numbers of antibodies. An antibody is a protein that sticks to a specific protein called an antigen. Antibodies circulate throughout the body until they find and attach to the antigen. Once attached, they can force other parts of the immune system to destroy the cells containing the antigen. Monoclonal antibodies (also called moAbs or mAbs) are a series of identical antibodies produced by a single clone of B cells. They are made in laboratories that act like proteins called antibodies in our bodies, which help stimulate our immune system. Monoclonal antibodies have been used to treat cancer, organ transplant rejection, inflammatory and autoimmune disorders, infections, and so on.

With advanced technology and experienced staff, Creative Bioarray provides comprehensive cell support services in the process development for monoclonal antibodies to help our customers worldwide. We delivered rapid and accurate results to assist customers to accelerate their research.

Our Processing of Monoclonal Antibodies

• Immunization of mice & isolation of splenocytes. Mice are immunized with an antigen and later their blood is screened for antibody production. The antibody-producing splenocytes are then isolated for in vitro hybridoma production.
• Preparation of myeloma cells. Myeloma cells are immortalized cells that, once fused with spleen cells, can result in hybridoma capable of unlimited growth. Myeloma cells are prepared for fusion.
• Fusion & selection. Myeloma cells and isolated splenocytes are fused to form hybridomas in the presence of polyethylene glycol (PEG), which causes cell membranes to fuse. Clones are screened and selected based on antigen specificity and immunoglobulin class.

Fig. 1 Approaches for the development of monoclonal antibodies.

• Antibody purification. Monoclonal antibodies may need to be purified before they are used for a variety of purposes. It's the golden standard for monoclonal antibody purification and technology that has gained high interest because of its great performance and capabilities.
• Functional characterization. Confirm, validate, and characterize each potentially high-producing colony.
• Quality control. After purification, a series of quality control tests are performed to ensure the quality of monoclonal antibodies.

The Role of Cell Banks in Monoclonal Antibodies Expression and Production

• Therapeutic antibodies are mainly produced in mammalian host cell lines including NS0 murine myeloma cells and Chinese hamster ovary (CHO) cells. The selection of an expression system is determined by its ability to deliver high productivity with acceptable product quality attributes.
• We provide cGMP-compliant NS0 and CHO cell banking services as a strong support to express monoclonal antibodies, which assure a batch of cells to guarantee the continuity of research, development, and manufacturing production plans.

As a professional services provider in the field of cell science, Creative Bioarray provides strong cell support in the process development for monoclonal antibodies to our customers worldwide. We provide our clients with direct access to our experts and prompt responses to their questions. If you are interested in our services or have any questions, please feel free to contact us or make an online inquiry.