Author Archives: Svetlana Bergelson

Identification and Quantification of Heat-Shock Protein 70: A Major Host-Cell Protein Contaminant from HEK Host Cells

by , , , , , , and

Recombinant therapeutic proteins are commonly produced by cell lines such as Chinese hamster ovary (CHO), human embryonic kidney (HEK) 293, murine myeloma (NS0), and Escherichia coli bacterial cells. Host-cell proteins (HCPs) are indigenous proteins produced by those expression hosts and considered to be process-related impurities generated from the cell culture process (1). HCPs are potentially harmful and immunogenic to patients, and they can compromise the stability of protein drugs (2–4). For those reasons, HCPs must be consistently removed or reduced…

October 15, 2015

Assay Acceptance Criteria for Multiwell-Plate–Based Biological Potency Assays

by , , , , and

For most biopharmaceuticals, potency is assessed in a bioassay by comparing dose–response curves of the test material and a reference standard. As with all analytical techniques, such assays require criteria by which their execution can be judged objectively to be valid, regardless of whether the desired or expected result is obtained for the test sample. PRODUCT FOCUS: BIOLOGICSPROCESSFOCUS: R&D, QCWHO SHOULD READ: PRODUCT AND PROCESS DEVELOPMENT, ANALYTICAL, QCKEYWORDS: IMMUNOASSAYS, POTENCY ASSAYS, PRODUCT RELEASE, REFERENCE STANDARDS, CONTROL SAMPLES, SAMPLE ACCEPTANCELEVEL: ADVANCED…

January 1, 2014