The United States Pharmacopeia (USP, Rockville, MD, www.usp.org) and the UK’s National Institute for Biological Standards and Control (NIBSC, Hertfordshire, UK, www.nibsc.ac.uk) are seeking participants for a study of analytical methods used by the industry to characterize and quantify oligosaccharides. The aim of the study is to gain information to direct the development of methodological general chapters for the USP and the European Pharmacopeia (EP), and to provide a resource for researchers to compare methodologies.
The study includes two major components, an online survey and a laboratory study. Participants in the laboratory study will receive four samples, each containing approximately 25 micrograms of a mixture of N-linked glycan chains cleaved from different glycoproteins. Participants will be asked to analyze the samples using their routine methodology, to identify and quantify the components, and send their results, including labeled chromatograms, to USP and NIBSC.
The study has two purposes, says Tina S. Morris, PhD, director of biologics and biotechnology at USP. Whereas the online survey is designed to find out what methods people use, the laboratory study is a benchmarking study that will examine laboratory proficiency.
“We want to compare the performance of the same kinds of methods when used in different laboratories, to examine the variants in the methods and the amount of information you can obtain using those methods,” she says. “We are asking participants to provide as much methodology information as possible, because we think this will be important as we write general chapters.”
The results of this study will primarily by used for a new general chapter <1095> on oligosaccharide analysis. The oligosaccharide chapter is one of four new general chapters dealing with glycoproteins and glycan structures that are currently being developed by the USP’s proteins and polysaccharides expert committee, through an ad hoc advisory panel.
Morris said the study will also help the USP and the EP develop general chapters on these topics at the same time, in a harmonized fashion. Martin Schiestl, PhD, who heads the USP ad hoc advisory panel, is also a member of the relevant EP committee on protein therapeutics.
The decision to provide participants with samples of released glycan chains, rather than having them perform their own deglycosylation, was a topic of lengthy discussion, Morris says. “Because there are so many issues with deglycosylation, we decided to deal with that separately,” she explains. “We thought it would introduce another source of variability.
In addition to using the information for drafting pharmacopeial chapters, USP and NIBSC plan to publish the results of the study in a journal. And if the study proves useful, the organizations may conduct similar studies in the future. “It’s definitely possible,” says Morris. “This is the first time we have done a study on this scale in the biotech area, so it’s a huge learning process for us.”
Deadlines for participants to enroll are fast approaching. Anyone interesting in participating in the laboratory study should enroll by March 30 by sending an e-mail message to Morris ([email protected]). Participants have until April 15 to respond to the online survey (available at http://www.usp.org/survey/DSD/ glycoprotein07.html). After signing up for the laboratory study, participants will be asked to complete an initial questionnaire before receiving samples to analyze. The organizers hope to be able to send out all the samples in May.