In Vivo Monoclonal Antibody Production
Your research and manufacturing cell lines must be developed by experts who can be trusted to exercise the same degree of care that you do. As your partner, Inotiv has exacting processes to meet your expectations.
Inotiv production of monoclonal antibodies for use in your diagnostic or therapeutic applications is carried out in our cGMP, FDA-registered facility. Our service utilizes a multi-phase production process with an extensive quality assurance program under the guidance of our knowledgeable technical and scientific staff.
When you entrust your mAb production to Inotiv, your project will receive the same consistent and reliable processes and procedures that your research and manufacturing environments require.
Receipt and expansion
Upon receipt, all cell lines are assigned an accession number for tracking purposes. The cell line is transferred to a quarantine area where it is grown in culture and expanded to create a cell bank.
MAP Testing and cell storage
MAP testing is performed on the cell stock. Our standard MAP panel tests for 19 murine adventitious agents, including mycoplasma. Testing is completed in approximately six weeks. After MAP testing, the cell stock is stored in a cGMP, alarmed, cryogenic tank for future runs.
Optimization and inoculation
Envigo offers a unique approach to research optimization for large-scale production. This involves performing a dosage study to determine time frames for ascites production development, mortality, incidence of solid tumors, volume of ascites, and concentration of immunoglobulin.
Optimization saves time and allows maximum monoclonal antibody yield. The ascites can be used by the customer for analysis prior to large-scale production.
As for your cost concerns? This unique service is provided at no additional cost for production runs of greater than 100 mice. Optimizations are available for smaller runs at an additional cost.
Production
With the MAP testing and optimization completed, production is initiated under cGMP guidelines. Complete line clearance is practiced at all points during the production process.
Harvest
Ascites is collected on wet ice and centrifuged to remove cellular and lipid material. The clarified ascites is placed into sterile containers, labeled and immediately frozen.
Quality control
Quality control on the final product can include subclass-specific RID to determine immunoglobulin concentration, USP sterility testing, 9CFR sterility testing, and determination of specific activity by ELISA and endotoxin testing. Final ascites is stored frozen at either -25°C or -70°C until it is ready for shipment.
Ascites production for research use
Ascites production for research includes the same phases as cGMP, however, MAP testing of the cell lines is not included thus reducing costs and decreasing turnaround time. Our technical staff will assist you at each phase of production. Should you need it, our protocols can be customized to meet your required specifications.
When you work with Inotiv, you can be confident that through our experience, we ensure consistent and reliable products for research and industry.
Discover how Inotiv helps companies in providing custom antibody services, click here to read more.
