Monoclonal Antibody (mAb) Lot Release Testing For CHO Cell–Derived Products

Ensuring the safety, quality, and consistency of monoclonal antibodies (mAbs) produced in Chinese Hamster Ovary (CHO) cells is essential for successful biologics programs. Because these complex glycoproteins are expressed in living systems, critical quality attributes—such as glycosylation patterns, charge variants, and aggregation levels—are heavily influenced by manufacturing conditions. To protect patient safety and confirm product comparability, testing requirements evolve across bulk harvest, drug substance, drug product, and stability testing stages.

Minaris Advanced Testing delivers comprehensive lot release testing panels tailored for CHO-derived therapeutics. Supported by GMP-compliant laboratories, these services encompass molecular identity, impurity profiling, glycan analysis, potency bioassays, and compendial safety testing.

Download the full poster to review complete testing panels and specifications.