Abstract
The influence of lyophilization on the stability of a monoclonal antibody (MN12) was investigated. MN12 was freeze-dried in different formulations [without lyoprotectant or in the presence of sucrose, dextran, or hydroxypropyl-β-cyclodextrin (HPβCD)] and under varying conditions (with or without secondary drying). Subsequently, the monoclonal antibody was stored for 18 or 32 days at various temperatures (4, 37, or 56°C). For comparison, solutions of MN12 were stored under the same conditions. Regardless of the lyoprotectant used, precipitation and a concomitant reduction of the antigen-binding capacity by about 10% were observed upon recon-stitution of lyophilized MN12. HPβCD proved to be the most effective stabilizer to prevent degradation of lyophilized MN12 during storage. Compared with MN12 solutions, HPβCD-containing lyophilized MN12 cakes were more resistant to heat-induced charge alterations and loss of antigen-binding capacity.
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Ressing, M.E., Jiskoot, W., Talsma, H. et al. The Influence of Sucrose, Dextran, and Hydroxypropyl-β-cyclodextrin as Lyoprotectants for a Freeze-Dried Mouse IgG2a Monoclonal Antibody (MN12). Pharm Res 9, 266–270 (1992). https://doi.org/10.1023/A:1018905927544
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DOI: https://doi.org/10.1023/A:1018905927544