Potential Process Control Issues With Abatacept

Abatacept is a medication administered through intravenous infusion. It is supplied as a sterile, white, preservative-free, freeze-dried powder. Each vial of drug contains 250 mg abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration. Abatacept is a fusion protein consisting of the extracellular domain of CTLA-4 linked to the modified Fc portion of human immunoglobulin G1. It is produced using recombinant DNA technology. Abatacept is indicated for moderately to severely active rheumatoid arthritis in adults and polyarticular juvenile idiopathic arthritis in pediatric patients 6 years of age and older. It can be used as monotherapy or in combination with other disease-modifying antirheumatic drugs or methotrexate. Inter-lot variability was detected in a library of 132 vials spread across 34 lots of abatacept-maltose for injection by the University of Kentucky Drug Quality Task Force. A subcluster detection test was run on 13 vials that were shown to be an outlier group (r_tn=0.9940, r_test=0.9551, r_lim=0.9865, p=0.02). Five of these vials individually appeared 4 or more standard deviations from the library cluster.