Report from the Field, author/photos Helen Triolo

Ever wondered how the U.S. Pharmacopeia works? We did, and were glad to respond to USP’s invitation to find out with an Explorations! Field Trip to USP on July 7. Twenty Rockville Science Center members were treated to an afternoon of Q & A about USP’s operations in their Rockville headquarters and around the globe, plus a tour of their extensive Reference Standards Lab and a visit to their museum room. The Q & A began with Damián Cairatti, Director of USP’s Latin American Regulatory Affairs, telling us about the first U.S. Pharmacopeial Convention held in 1820, attended by 11 physicians (3 of whom were US senators), to determine and standardize the “recipes” for then commonly used drugs.

Damián Cairatti, Director of USP's Latin American Regulatory Affairs

Damián Cairatti, Director of USP’s Latin American Regulatory Affairs

USP’s mission has changed over the years to now focus on defining standards for strength, quality, and purity of drugs recognized as official and enforced by FDA (following the Food, Drug and Cosmetic Act of 1938), and the publication of monographs, which contain detailed chemical information about each drug, as well as for foods and dietary ingredients.

USP labs carry out the testing required to produce the monographs, but committees of experts (from academia, FDA, pharmaceutical companies, public health organizations and elsewhere) meet once every five years as volunteer Convention members to discuss and adopt specific focus areas for the next five-year period.

RSC Member Melanie Boslego peruses one of 4 volumes of the current USP monograph.

RSC Member Melanie Boslego peruses one of 4 volumes of the current USP monograph.

Lukas Roth, Program Manager of Global Health Impact Programs, noted that USP now has a global presence with offices and labs in India, China and Brazil. 40 countries recognize USP standards for food and drugs in their laws. Exchange programs allow USP to work with scientists around the globe via their Visiting Scientist Program, the International Training Programs, and USP Global Fellowship Program. USP has also expanded operations with the recently inaugurated Center for Pharmaceutical Advancement and Training in Ghana, as well as others sites in Nigeria, Ethiopia, Indonesia, and the Philippines.

Lukas Roth, Program Manager of Global Health Impact Programs

Lukas Roth, Program Manager of Global Health Impact Programs. The slide says that 20% of essential medicines on WHO’s list do not have monographs, so there is no way to test their quality – a statistic that USP is working to change.

Mike Ambrose, Ph.D., then spoke about the work of the 6 scientists in USP’s Biologics Lab, which he directs, and the equipment they use to carry it out, from Bruker spectrometers for protein identification and characterization and LI-COR infrared imaging systems, to incubators, flow cytometers, and other lab equipment like autoclaves and refrigerators. He spoke about USP’s ever-present need to find a balance between state-of-the-art equipment that can give the most precise results and equipment that will be available for others around the globe to use to carry out the same kinds of testing.

Mike Ambrose, PhD Director of Biologics and Biotechnology Laboratory

Mike Ambrose, PhD Director of Biologics and Biotechnology Laboratory

Dr. Arthur Strohl, a Fellow at the Reference Standards Lab, gave us a tour of the extensive Reference Standards Lab, beginning with the Dissolution Lab, where testing allows USP to determine whether and at what rate various supplements are dissolved in the stomach and/or intestine.

Dr. Arthur Strohl showing us around the Reference Standards Lab at USP

(Yes, there really is such a thing as a Dissolution Lab)

Representative samples of the activity involved in each part of the Reference Standards Lab are helpfully posted in charts and graphs in the window of the lab.

RSC's Katherine Perez explaining this graph, posted in USP's Reference Standards Lab.

RSC’s Katherine Perez explaining the meaning of this graph to me.

Our final stop was in the museum room at USP, where their history as an organization from 1820 to the present is documented and displayed. Most enjoyable to me were a series of selections from the monograph compendia over the years (display by Eli Begoun, USP Information Center Specialist) showing how the entry for glycerin has changed from 1820 to the most recent published year. Here’s a sampling:

Glycerin, as described in the monograph from 1820.

Glycerin, as described in the monograph from 1820.

Glycerin: an entry in one of the monograph compendia between 1820 and 2016

Glycerin: an entry in one of the monograph compendia between 1820 and 2016

Glycerin, as described in the most recently published monograph by USP

Glycerin, as described in the most recently published monograph by USP