The safety of biopharmaceutical products - A personal viewpoint

There are now published guidelines dealing with the production of cytokines, monoclonal antibodies and other therapeutic proteins made by applying biotechnological procedures. Strict conformity with these guidelines will undoubtedly yield safe products, but the question can be asked whether all the tests now specified are really essential in relation to the actual risks involved. During many years of experience with some of these biopharmaceutical products, problems which might on theoretical grounds have occurred have in practice not been encountered. Should biopharmaceuticals still be subjected to a much more intense scrutiny than is given to most other medicinal products? Has the time come to review current control procedures? Unnecessary tests increase the cost of products, and may make them too expensive to be available to millions of people who would benefit from their use.