Manufacture and purification of products is performed in dedicated clinical and non-clinical areas of the facility in compliance with regulatory standards. The facility maintains stringent quality control standards for each step of the production process. In some instances, suitable culture methodologies as alternatives to ascites production may be obtained. Production of Purified Monoclonal Antibodies Production and purification services ranging from milligram to gram quantities of monoclonal antibodies. Initial requests are generally performed as pilot projects, and subsequent scaled production are designed to meet investigator's requirements for optimal product yield, homogeneity and removal of potential contaminants such as endotoxin.
Support is provided for regulatory submissions required for clinical studies.