Analytical Sciences

Analytical Comparison of Antibody-drug Conjugates Based on Good Manufacturing Practice Strategies

Zhala TAWFIQ,* Yutaka MATSUDA,** Melody Jane ALFONSO,* Colin CLANCY,* Veronica ROBLES,* Monica LEUNG,* and Brian A. MENDELSOHN*

*Ajinomoto Bio-Pharma Services, 11040 Roselle Street, San Diego, CA 92121, United States
**Ajinomoto Co., Inc., 1-1 Suzuki-cho, Kawasaki, Kawasaki, Kanagawa 210-8681, Japan

The production of antibody-drug conjugates (ADCs) has been in great demand in the field of cancer therapeutics. Although cysteine-based conjugation is the most common and well known process for producing ADCs, multiple analytical methods are required for accurate drug-antibody ratio (DAR) determination due to the heterogeneity of the ADCs. Here we report various analytical methods for DAR analysis of traditional cysteine-based ADCs; additionally, apply a good manufacturing practice (GMP) strategy to produce a four hundred milligram ADC batch for use in good laboratory practice (GLP) studies. The work described herein not only evaluates several analytical performances but also provides guidance for future phase appropriate ADC production while establishing a unique analytical strategy.

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