Quality Evaluation of Human Serum Albumin Based on Charge Variants

OBJECTIVE To establish a detection method for human serum albumin(HSA) charge variants and provide new scientific basis and strategies for their quality evaluation.

METHODS The whole column imaging capillary isoelectric focusing electrophoresis(icIEF) technology was employed to establish a detection method for HSA charge variants. This was achieved by examining urea concentration, range of zwitterionic electrolytes, and focusing time. Quality analysis was conducted on 50 batches of products.

RESULTS The main charge variants of HSA were pI 5.5−5.6, pI 4.9−5.0, and pI 5.2, with pI5.5−5.6 accounting for over 80%. The results of 50 batches of HSA showed that the content of charge variants could reflect the inter-batch variability more accurately than that of gel electrophoresis.

CONCLUSION Charge variant detection can be used to evaluate inter-batch variability and production process stability of HSA.