EVALUATION OF SMALL TO MODERATE SCALE IN-VITRO MONOCLONAL-ANTIBODY PRODUCTION VIA THE USE OF THE I-MAB(TM) GAS-PERMEABLE BAG SYSTEM

The i-MAb Monoclonal Antibody Production kits, based on the use of gas -permeable (GP) bags, were developed to offer researchers a viable alt ernative to existing in vitro techniques and ascites for the productio n of monoclonal antibodies (mAbs). Twelve core hybridoma facilities an d commercial antibody laboratories were provided samples of the kit to evaluate the i-MAb system. Forty-nine GP bags were tested, with 30 di stinct hybridoma cell lines evaluated for mAb production. The mean yie ld of purified antibody from one 500 ml i-MAb GP bag was 36.9 mg (n=47 ), with a range of 1.8-102 mg of purified mAbs. Similar variation in m Ab production has been reported when comparing this system with other in vitro methods as well as ascites. Based on cost estimates provided by the beta test facilities, the mean cost of producing mAbs via the G P bag was US $1.82/mg. Two of the GP bags did not produce mAbs due to mycobacterium contamination. The cost includes all materials, labour a nd media required to produce the mAb. All hybridoma lines produced fun ctional antibody via this technique. While the use of a GP bag is curr ently limited to small and medium scale (5-150 mg) mAb production; it does offer several distinct advantages to current in vitro and in vivo methods.