Stability Evaluation of the Biosimilar Monoclonal Antibody Using Analytical Techniques

INTRODUCTION: Determination of the drug substance (DS) and drug product (DP) stability is especially important for biosimilar monoclonal antibodies since it can affect the quality, efficacy, and safety of the drugs. The main objective of this study was to determine the stability of the biosimilar candidate (TUR01) using state-of-the-art (current) analytical techniques.
METHODS: Analytical techniques used in this study were isoelectric focusing capillary electrophoresis (icIEF), capillary electrophoresis-sodium dodecyl sulfate (CE-SDS), size exclusion chromatography (SEC-UPLC), binding affinity, physicochemical and microbiological tests. Drug substance was kept in PETG bottles at ≤ -65.0°C and 5.0°C ± 3.0°C for 18 months, where the pre-filled syringe stability study was carried out at 5.0°C ± 3.0°C for 24 months and 25.0 ± 2.0°C / 60% ± 5 RH for 6 months. The accelerated condition for DS was accepted as 5.0°C ± 3.0°C, while it was 25.0 ± 2.0°C for the DP.
RESULTS: The results indicated that TUR01 DS was stable when stored under long term storage conditions at ≤ -65°C and also at 5 ± 3℃ at least 18 months. Also, the TUR01 DP was stable at 5 ± 3℃ for 24 months and at 25 ± 2℃ with 60 ± 5% relative humidity (RH) for 2 months without any significant changes.
DISCUSSION AND CONCLUSION: State-of-the-art analytical techniques proved to be invaluable tools to evaluate the stability of the TUR01 drug substance and drug product.