Technical and ethical limitations in making human monoclonal antibodies (an overview)

In the broadest sense there are no longer any technical limitations to making human mAbs. Biological issues involving the type and nature of either a synthetic or a natural antibody, advantages of various B cell immunological compartments, and various assays needed to qualitate and quantitate mAbs have essentially been solved. If the target antigen is known then procedures to optimize antibody development can be readily planned out and implemented. When the antigen or target is unknown and specificity is the driving force in generating a human mAb then considerations about the nature and location of the B cell making the sought after antibody become important. And, therefore, the person the B cell is obtained from can be an ethical challenge and a limitation. For the sources of B cells special considerations must be taken to insure the anonymity and privacy of the patient. In many cases informed consent is adequate for antibody development as well as using discarded tissues. After the antibody has been generated then manufacturing technical issues become important that greatly depend upon the amounts of mAb required. For kilogram quantities then special considerations for manufacturing that include FDA guidelines will be necessary.