1968–2018: Five Extraordinary Decades of American Laboratory

Fifty years ago, the scientific instrument business was very small (~$250 million) dominated by a few multiproduct vendors, including Beckman and Perkin-Elmer (now PerkinElmer). Varian and Hewlett-Packard were expanding by acquisitions. Strip-chart recorders with ball-and-disk integrators were considered automated, labor-saving products.

American Laboratory first appeared in my mailbox in October of 1968. A few days later, I was honored to meet the publishers, William Wham and Kenneth Halaby, who explained the editorial focus of their new journal: communicating practical advances in products and technology to scientists in the chemistry and life science laboratories. Over the past 50 years, I’ve submitted more than 600 articles and blog posts in this regard.

When American Laboratory’s “Big 50” started to appear on the planning horizon, I looked back on the major advances I’d seen but not appreciated. There were many potential topics. My distillations are:

Science-based regulation

To me, the most significant advance spanning the last 50 years is the success of science-based regulation, particularly in the areas of biopharmaceuticals, environmental chemistry, and clinical diagnostics.

Biopharmaceuticals

I invited Professor William Hancock to write about the development of science-based regulation in biotherapeutics (read article here). Some will recall that, prior to 2004, the original regulatory approach was one facility making one product. The process defined the product. Once the Biologics License Application (BLA) was approved, the process was “locked down” and could not be changed, except with new clinical trials. The catch was that the facility for biologics had to be built and produce three consistent batches before the FDA would grant marketing approval (BLA). The cost of one facility was about $0.5 billion, which was unaffordable.

In a daring move at the time (2004), the FDA transferred responsibility for biotherapeutics from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). This changed the regulatory philosophy to the analytical science-based paradigm that FDA had used successfully for small-molecule therapeutics. Today, BLA approvals require only six months (priority) to 12 months (standard).

Professor Hancock was working as head of analytics at Genentech. The key question was: Did industry have the tools and experience required by the new paradigm? Developers of bioanalytics methods and instruments scrambled, but today, approvals are less time-consuming and the quantity is increasing.

Environmental chemistry

In my lifetime, I’ve seen a tremendous improvement in the quality of our air and groundwater. Initially, I was skeptical of the then-new EPA, but five decades of progress have shown substantial improvement. I’m convinced that our society is benefitting in aesthetics and improved health. I had a chance to discuss this with Professor Susan Richardson (see article).

Clinical diagnostics

Clinical chemistry is much older than 50 years. But, to me, the relevancy and utility of clinical diagnostics really started to improve in December of 1967, with approval of the Clinical Standards Act that led to the Clinical Laboratory Improvements Amendments (CLIA). Today, clinical labs are churning out useful, high-quality data that helps keep us all alive. Dr. Carl Burtis, a past president of the AACC, highlights a few of the major advances here.

The laboratory environment

We all work in a chemical environment. When I was in school, labs had a chemical smell. Lab safety was not a significant topic. With the advent of OSHA and a few tragic accidents, things have changed for the better. Also, laboratory design and ergonomic workstations are helping to improve productivity and safety. Mike Regan of Plas-Labs discusses protecting the laboratory processes and staff here.

Forensic science

I did not think forensic science qualified for inclusion in the list of successful science-based regulations. Indeed, the 2009 report on the abysmal state of forensic science in the U.S. was a disqualifier. However, I’m impressed with both the progress that NIST’s Organization of Scientific Area Committees (OSAC) program is making to mitigate the deficiencies and with the dedication of the forensic scientific community to resolve them. The task may take another 20 years, but America must have confidence in science-based forensics.

Key enabling technologies

HPLC

The papers above show the evolution of important application segments. What about the key enabling technologies? In the last 50 years, separation science has dominated the technology space for the laboratory. HPLC is the leader in sales dollars, accounting for a bit over 10% of the $55 billion global revenue for laboratory instrumentation (excludes clinical analyzers). Dr. Ron Majors reports on liquid phase separations, including sample prep prior to chromatography, here.

Gas chromatography

Our world could not function without gas chromatography, which enables commerce of essential products including natural gas, gasoline, and diesel fuel. Our drinking water often comes from a river that passes through a series of cities (and sewers) on the way to the ocean. Since Agilent is the global leader in gas chromatography, I interviewed CEO Mike McMullen, who started at Agilent in GC about 30 years ago.

Mass spectrometry

I’m sure the last 50 years will be seen as the golden age of mass spectrometry. In the 1960s, there were a few instruments in leading petroleum labs doing mostly qualitative analysis, but the instruments were large and generally temperamental. Professor David Sparkman of the University of the Pacific in Stockton, CA, is a noted expert in MS. (Read article here.) 

Innovators and visionaries

Science is a human endeavor. Motivations are individual. The advances in the last 50 years are the work product of thousands of scientists and entrepreneurs who joined forces to build programs and companies that distilled these visions to practice.

Academia

In the academic world, there are many leaders in numerous disciplines. Professor Barry Karger is one outstanding example. Decades ago, he saw the need for more specific analytical technology to solve the riddles of homeostasis. In the 1960s, he started with HPLC, then moved on to capillary electrophoresis, followed by LC and CE coupled to MS. He kept his vision of microscale separations and the analysis of biologicals. After all, to understand biochemistry on the molecular level, one needs to work with single molecules. (Read article here.)

Entreprenuers

The Pittcon Hall of Fame documents the amazing contribution of many entreprenuers who invested to bring essential products our labs.

Dave Regan founded Plas-Labs 50 years ago (read article here).

Kevin Hrusovsky is an example of a visionary entrepreneur. In the 1980s, he founded Zymark, which used an industrial robot to perform laboratory operations. This led directly to high-content analysis, which is so powerful in screening and uncovering structure–activity relationships. About a decade later, Hrusovsky moved on to Caliper, where he pushed the expansion of the assay-on-a-chip. Caliper was successful in building a business by providing complete assay systems that used microfluidics technology. A couple of decades later, Hrusovsky surfaced at Quanterix, known for its innovative approach to highly specific assays of single molecules. (Read article here.)

Barry Karger, Kevin Hrusovsky, and Mike Regan have demonstrated exceptional passion for their work spanning decades. Passion is a key quality attribute that is essential for success in science.

Conclusion

Why does American Laboratory continue to be a leading communications channel to laboratory scientists? Because we seek out and publish reports from authors who show passion for their message. You, the subscribers and readers of American Laboratory, show passion for our content as a valuable communications channel for your work. We thank you sincerely as we usher in the next 50 years!

With a smile,

Robert Stevenson, Ph.D., Editor Emeritus

Donna Frankel, Director of Editorial

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