MIPS Project Detail:

MedImmune, Inc.

Developing Procedures to Characterize Glycoproteins

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Company

MedImmune, Inc.

Gaithersburg

Montgomery

County

, Maryland

Founded:

1988

Website:

http://www.medimmune.com/

Company Description:

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology, Respiratory, Cardiovascular & Metabolic Diseases, and Infection and Vaccines. MedImmune is headquartered in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers, with additional sites in Cambridge, UK and Mountain View, Calif.

MedImmune’s SYNAGIS therapeutic is an FDA-approved prescription injection of antibodies that is given monthly to help protect high-risk infants from severe respiratory syncytial virus, or RSV.

RSV is a common virus that, like the flu, is seasonal and easily spread. Most children will get RSV by the age of two. RSV begins with cold-like symptoms but can spread to the lungs. For babies with certain health conditions, RSV can be very serious.

SYNAGIS is the first monoclonal antibody approved for the prevention of an infectious disease, as well as the first such drug to be safely used in children.

MIPS Project

Developing Procedures to Characterize Glycoproteins

Project #

1906

|

MIPS Round

19 |

Starting Date:

Feb 1997

MIPS Project Challenge:
The overall purpose of this project was to develop novel analytical procedures for the characterization of glycoproteins, especially with respect to their carbohydrate content. Initial studies were focused on the carbohydrate structural characterization of MEDI-493 (SYNAGIS) and MEDI-500.

Project Scope:
LaCourse’s research was slated to progress from total carbohydrate composition and site of glycosylation to the determination of heterogeneity aspects of the oligosaccharides moieties. Advanced methods of analysis included High Performance Anion-Exchange Chromatography, followed by Pulsed Electrochemical Detection and Pulsed Voltammetric Detection, which was unique to LaCourse’s research group. It was anticipated that a successful project could result in a methodology for the quality control of biopharmaceuticals, which would facilitate licensing and approval by the FDA. The procedures would be generally applicable to glycoprotein-based biopharmaceuticals and bio-compounds throughout the biotechnology sector.

The project went very well. Bill LaCourse is a world-class leader in the pulsed amperometric detection of carbohydrate proteins.

Mark Schenerman, Former VP, Analytical Biochemistry, Medimmune

Results:

The data acquired by LaCourse helped with the FDA approval of SYNAGIS.

Additional Information:
LaCourse says that perhaps his greatest contribution to the project was thengraduate student Christine Zook (now Christine Holland), who went on to work for MedImmune. LaCourse cites that she “was one of the best [graduate students] I ever had.”

MIPS has jointly funded six different research projects with MedImmune, including
three directly related to SYNAGIS since 1996.

We helped with the development of analytical methods to characterize glycoproteins. This potentially helped MedImmune with the quality control of their products, including SYNAGIS, and drug discovery in general. To acquire FDA approval for a drug, you have to characterize everything and do it well to make sure you are making the same product over and over. Using a more advanced technique gives more confidence to the FDA that you know what you are doing.

William LaCourse, Professor, Department of Chemistry and Biochemistry, UMBC