ACA measures the capacity of a test article to consume or activate complement under defined in vitro conditions. In a hemolysis-based format, residual complement after test-article incubation is quantified through lysis of sensitized erythrocytes, allowing complement consumption to be compared with appropriate controls or reference materials.

Projects may include IVIG and other immunoglobulin preparations, monoclonal antibodies, Fc-fusion proteins, recombinant proteins, formulation candidates, process intermediates, stressed materials, and other research biologics or compounds after a feasibility review.

The original service commonly uses approximately 0.5-1 mL per condition as a practical starting range. Final material requirements depend on concentration, number of replicates, dilution series, comparator arms, and whether follow-up complement assays are included.

Yes. Lot-to-lot, pre/post-process-change, formulation, storage, or stress comparisons can be run under harmonized conditions with a shared complement source and reference controls to improve interpretability.

No. Aggregate analysis describes a physicochemical state, whereas ACA provides a functional measure of complement interaction. The two are complementary, and combining them can be useful when investigating whether aggregation or other product-related species contribute to complement consumption.

Yes. Depending on the question, ACA can be paired with activation products such as C3a, C5a, or sC5b-9, deposition assays such as C3b or C5b-9, or total/pathway-specific function testing to distinguish complement consumption from downstream activation signatures.

Helpful information includes sample type and concentration, formulation, storage and stress history, number of lots or conditions, available comparators, expected complement risk, intended study decision, required replicates, and any orthogonal analytical or complement data already available.