Histories of biotechnology—both of an emerging industry and of specific products, typically medicines—have been published since the early 1980s. They now fall into a few discrete genres: long-wave histories describing scientific and market change over the past 150 years or more; histories of radical breakthroughs and new biotechnology as a health-care disruptor; histories seeking to inform the public of how underlying techniques and technologies work; more analytical works exploring social, political, and economic issues arising from or feeding into biotechnology as an industry; and finally, histories of companies and biographies of scientists and founders of start-ups. Today, forty years since success with recombinant DNA techniques and thirty-six years since the first biotechnology company initial public offering, biotechnology is no longer a new science, new industry, or even new hybrid of academia, government, and the private sector. Yet lead participants and academic analysts continue to characterize it in very different ways, giving priority alternatively to novelty and the promise of the next revolution or to continuity and the longer track record of research, testing, and marketing that underpins today's biotech sector.

In this thoroughly researched and pioneering account of monoclonal antibodies (MAbs), Lara Marks draws attention to continuities in biotech's history. The book focuses on the underlying but often ignored molecules and associated techniques and technologies comprising MAbs that biomedical researchers have studied and used longer than stem cells or even genetic engineering—but with far less attention from the press, investors, or historians. Six of the twelve top-selling pharmaceuticals in 2012 were MAb-based therapies, and MAbs have wide uses in diagnosis (e.g., blood typing, home pregnancy testing, cancer determination) and the manufacture of other medicines (notably, to purify biological drugs). Yet, they have no single invention or discovery moment, instead emerging out of antibody research dating to the late nineteenth century and gaining new attention starting in the 1970s made possible by their cheaper production through the use of immortal cancer cell lines.

Curiously not positioned relative to the existing secondary literature on biotechnology in business history, history of medicine, or other scholarly work, The Lock and Key of Medicine closely tracks MAbs from the laboratory to the clinic, back to the lab, to the clinic in modified form, and to market for a number of interesting applications. Key figures, including David Murray, the founder of the U.K.-based Sera Lab, and Hubert Schoemaker, leader of Centocor, are cast as “intrepid” as they overcome scientific challenges, investor apathy, rigid bureaucracy, and nearly a decade of market failures from the mid-1980s through the early 1990s. For the first time, readers can learn the back story of Sera Lab (subsequently Celltech) and Centocor, which emerged as the market leaders by working closely with diverse medical diagnostics firms and tapping into an expanding market for cancer diagnostics. Efforts by Centocor and others to shift from diagnostic to therapeutic uses for MAbs, however, were fraught with challenges when the human immune system attacked MAbs derived from mice or rats as foreign.

Marks is at her best describing the molecules themselves, the scientists and business executives, and the evolving technologies used to produce and use MAbs. Scientific and business disputes arise, but Marks is less clear on why they are resolved in particular ways. Was it because of social and economic choices, or do inherently better techniques win out? American involvement with MAbs started at the Wistar Institute in Philadelphia and involved international exchanges or gifts of materials until increasing commercial potential led to priority disputes between labs in the United Kingdom and the United States. Distribution of MAbs then shifted from laboratories exchanging samples to their commercial production and sale. Marks also explains the importance for Centocor of negotiating and timing stock market moves and managing the relationship and communication with regulators who were unfamiliar with the new class of drugs. Centoxin, a treatment for sepsis, is a striking case study of the highs and lows of drug development and the multiple lives of a biotech firm as initial clinical data appear very promising but then the drug fails in larger trials. Centocor's subsequent work on abciximab (ReoPro) demonstrated learning about how to structure trials and set a market price that insurers would reimburse. The book brings MAb development up to the 2010s with details of the development of rituximab and infliximab, which are among the top-selling biotech drugs at present. While still targeting orphan diseases, these are not individualized therapies as initially envisioned, but rather high-priced specialized medicines.

The Lock and Key of Medicine will interest historians of medicine and can serve as good reading for graduate seminars in twentieth-century biomedicine. Nonspecialists wanting to learn about the scientific and intellectual history of immunology, and MAbs specifically, will find it a useful introduction. Those interested in the broader political economy of biotechnology will want to look elsewhere.

Even more so than other biotech drugs, MAbs pose profound public-policy choices. Significant government research funds, restrictive patent thickets, and monopoly pricing on treatments are justified as underwriting eventual public availability of safe, effective, and inexpensive generics. But as Marks observes, whether generics will ever succeed for MAb drugs is uncertain; their complexity and unpredictable impacts on the body mean that any molecular modification can result in life-threatening side effects. Marks concludes with potential future uses of MAbs as anti-infectives, although that possibility is quickly undermined by the pricing and patent issues she has depicted. She then switches gears to envision expanded use of MAbs for the diagnosis of viral, bacterial, and parasitic infections. Perhaps this is the ultimate takeaway for biotechnology more generally: for better or worse, the sector operates on a cycle of research breakthrough, hype, funding, product development, more funding, testing, then calibration to a reality of modest health gains for a subset of people with disease.