cGMP and Non-cGMP Research In Vivo Production

In Vivo cGMP Antibody Production for Diagnostic and Therapeutic Use

Harlan Bioproducts for Science, Inc. (HBPS) production of monoclonal antibodies for use in diagnostic or therapeutic applications is carried out in our cGMP, FDA-registered facility. This service utilizes a multi-phase production process with an extensive quality assurance program.

• 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
  HBPS offers a unique research optimization for large-scale production. This involves performing a dosage study to determine time frames for ascites 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. 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.

• QC
  Quality control on the final product can include subclass specific RID to determine immunoglobulin concentration, U.S.P. sterility testing, 9CFR sterility testing, 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.

In vivo Production for Research Use

 In vivo  production 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. We emphasize that our protocols can be customized to meet your required specifications.

To receive a Monoclonal Antibody Information Sheet, pricing, or for more information about our capabilities, contact our National Customer Services Center at 800-9SCIENCE. Our technical staff is also available to assist you in determining the type of production system that best meets your needs.