A non-isotopic probe-hybridization assay for residual DNA in biopharmaceuticals.

Although most biopharmaceuticals are highly purified, there is a theoretical concern that such recombinant products could be contaminated with oncogenic or bacterial DNA. A crucial part of the control of such biologicals is to ensure they do not contain more residual DNA than a safety limit suggested by the regulatory agency. Currently, the FDA has suggested a 100 pg per dose limit for residual DNA.

Immunochromatographic analysis of proteins. Identification, characterization and purity determination.

Antibodies specific to a protein and its structural variants were immobilized on a high-performance Protein G column. This column recognized and selectively subtracted specific molecules from a sample. When a size-exclusion column was coupled with this high-performance affinity column, a comparison between the elution profile before and after the antibody immobilization was used to study antigen components present in the sample.

Solution stability of the monoclonal antibody-vinca alkaloid conjugate, KS1/4-DAVLB.

A 3-month solution stability study at 5 degrees C of the monoclonal antibody-vinca alkaloid conjugate KS1/4-DAVLB indicated that phosphate-buffered saline solutions at pH 4.5-5.5 had little tendency to lose vinca by hydrolysis, improved vinca stability, showed acceptable physical stability, and formed minimal amounts of soluble aggregates compared to solutions at pH 6.