Phospholipase B-like 2 (PLBL2) is a lysosomal enzyme that can be secreted by Chinese Hamster Ovary (CHO) cells, the predominant cell line used for manufacturing therapeutic monoclonal antibodies and other recombinant biologics. Although not typically a focus in basic biological research, PLBL2 has gained attention in biopharmaceutical development as a host cell protein (HCP) impurity. During cell culture and downstream processing, PLBL2 may co-purify with therapeutic proteins, particularly monoclonal antibodies, and persist in the final drug product if not sufficiently cleared.
In research and clinical settings, PLBL2 is monitored primarily as a critical quality attribute due to its potential to trigger immune responses in patients. Studies have shown that residual PLBL2 can act as an immunogenic impurity, stimulating the production of anti-PLBL2 antibodies and potentially interfering with therapeutic efficacy or causing adverse immune effects. Consequently, sensitive immunoassays, such as ELISAs or mass spectrometry-based methods, are developed to detect and quantify PLBL2 during process validation, lot release, and immunogenicity risk assessments. Understanding and controlling PLBL2 levels is essential in ensuring the safety, purity, and regulatory compliance of CHO-derived biologics.
This product is manufactured in USA by Eagle Biosciences.