Stability Evaluation of the Biosimilar Monoclonal Antibody Using Analytical Techniques

Area of Science:

• Biopharmaceutical analysis
• Monoclonal antibody characterization
• Drug stability testing

Background:

• Biosimilar monoclonal antibodies require rigorous stability assessment to ensure quality, efficacy, and safety.
• The stability of drug substance (DS) and drug product (DP) is critical for therapeutic success.
• TUR01 is a biosimilar candidate requiring comprehensive stability evaluation.

Purpose of the Study:

• To determine the stability of the biosimilar candidate TUR01.
• To utilize state-of-the-art analytical techniques for stability assessment.
• To provide data supporting the quality and safety of TUR01.

Main Methods:

• Isoelectric focusing (IEF) on capillary electrophoresis (CE).
• Capillary electrophoresis-sodium dodecyl sulfate (CE-SDS).
• Size exclusion chromatography-ultra-high performance liquid chromatography (SEC-UHPLC).
• Binding affinity assays.
• Physicochemical and microbiological tests.
• Storage of DS in PETG bottles at ≤-65°C and 5°C for 18 months.
• Storage of DP in pre-filled syringes at 5°C for 24 months and 25°C/60% RH for 6 months.

Main Results:

• TUR01 DS remained stable for at least 18 months when stored at ≤-65°C and 5°C.
• TUR01 DP demonstrated stability for 24 months at 5°C.
• TUR01 DP showed stability for 2 months at 25°C with 60.5% RH without significant changes.

Conclusions:

• The biosimilar candidate TUR01 is stable under the tested long-term and accelerated storage conditions.
• Advanced analytical techniques are crucial for evaluating biosimilar stability.
• The stability data supports the quality and potential efficacy of TUR01.