Quantitation of DNA and protein impurities in biopharmaceuticals.
AuthorsBriggs J, Panfili PR
JournalAnal Chem
PubMed ID1858980
The development of drugs and biologicals for human injection generated from recombinant DNA and hybridoma technologies has resulted in new standards for product purity. We discuss the regulatory position relative to impurities in these biopharmaceuticals, focusing on the analytical goals for quantitation. Current methods for making these measurements are reviewed, ... More