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Thirty-five years on from the FDA’s approval of a first monoclonal antibody, these biologics account for nearly a fifth of the agency’s new drug approvals each year.
In the mid-1970s, immunologist Stuart Schlossman had a lab space problem. In order to unravel the ins and outs of T cell biology, he was working with a then-new and revolutionary method for purifying monoclonal antibodies. The hybridoma technique — which Georges Köhler and César Milstein won a Nobel prize for in 1984 — involves inoculating mice with antigens, extracting spleen cells, fusing these with cancer cells and then growing up the immortalized antibody-secreting B cells. For Schlossman, that would mean lots and lots of plates of cells in his Harvard Medical School lab. “We were worried that we just wouldn’t have enough room in our incubators to keep all the cultures going,” he recalled, four decades on.