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Article: CBER creating new analytical technologies to better weed out impurities in biotech products, FDAer tells WilBio.(Impurities/analytical methods)
- Article from:
- Validation Times
- Article date:
- August 1, 2005
- Author:
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MCLEAN, VA -- The Center for Biologics is developing new analytical technologies to improve the safety, purity and potency of biological products that will more accurately measure the amounts of preservatives, metals, stabilizers, adjuvants, chemical inactivators, nitrogen and residual moisture present in biological products, a CBER official said here Aug. 9.
According to Joan May, Ph.D., director, Laboratory of Analytical Chemistry, Office of Vaccines Research and Review, the research into new techniques "involves the identification, structural elucidation or quantitation of chemical constituents or chemical impurities in vaccines and other biological products ...