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Potential Process Control Issues With Abatacept.

James T Isaacs¹, Philip J Almeter^1,2, Aaron N Hunter¹

¹Department of Pharmacy Services, University of Kentucky Healthcare, Lexington, KY 40536.

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|August 25, 2025

Summary

This summary is machine-generated.

Variability in abatacept-maltose for injection lots was detected, with some vials appearing as outliers. This finding highlights the importance of quality control in biologic drug manufacturing for rheumatoid arthritis treatments.

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Area of Science:

Pharmacology and Drug Quality Assurance
Biopharmaceutical Manufacturing

Background:

Abatacept is a biologic medication used for rheumatoid arthritis and juvenile idiopathic arthritis.
It is administered as an intravenous infusion and manufactured using recombinant DNA technology.

Purpose of the Study:

To assess inter-lot variability in abatacept-maltose for injection.
To identify potential quality control issues in manufactured batches of abatacept.

Main Methods:

Analysis of 132 vials across 34 lots of abatacept-maltose for injection.
Application of subcluster detection tests to identify outlier vials.
Statistical analysis including outlier detection based on standard deviations.

Main Results:

Significant inter-lot variability was detected in the analyzed abatacept-maltose for injection library.
A subcluster detection test identified an outlier group of 13 vials.
Five vials were found to be 4 or more standard deviations from the main cluster, indicating significant deviation.

Conclusions:

The study identified variability in abatacept-maltose for injection lots, suggesting potential manufacturing inconsistencies.
These findings underscore the need for stringent quality control measures in the production of biologic drugs like abatacept.