HSEIN, Hassana; AUFFRAY, Julie; NOEL, Thierry; TCHORELOFF, Pierre

doi:10.1080/10837450.2022.2131818

Institut de Mécanique et d'Ingénierie [I2M]

AUFFRAY, Julie

Institut de Mécanique et d'Ingénierie [I2M]

NOEL, Thierry

Microbiologie Fondamentale et Pathogénicité [MFP]

Langue

Article de revue

Ce document a été publié dans

Pharmaceutical Development and Technology. 2022-10-19, vol. 27, n° 9, p. 942-955

Résumé en anglais

Monoclonal antibodies constitute nowadays an important therapeutic class and the number of approved molecules for clinical uses continues to increase, achieving considerable part of the therapeutic market. Yet, the stability in solution of these biopharmaceuticals is often low. That is why freeze-drying has been and remains the method of choice to obtain monoclonal antibodies in the solid state and to improve their stability. The design of freeze-drying process and its optimization are still topical subjects of interest and the pharmaceutical industry is regularly challenged by the requirements of quality, safety and efficiency set by the regulatory authorities. These requirements imply a deep understanding of each step of the freeze-drying process, developing techniques to control the critical parameters and to monitor the quality of the intermediate and the final product. In addition to quality issues, the optimization of the freeze-drying process in order to reduce the cycle length is of great interest since freeze-drying is known to be an energy-expensive and time-consuming process. In this review, we will present the recent literature dealing with the freeze-drying of monoclonal antibodies and focus on the process parameters and strategies used to improve the stability of these molecules and to optimize the FD process.< Réduire

Mots clés en anglais

Freeze-drying

Monoclonal antibodies

Optimization

Process parameters

Product quality attributes

Stability

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https://oskar-bordeaux.fr/handle/20.500.12278/172332

DOI

http://dx.doi.org/10.1080/10837450.2022.2131818

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Recent advances and persistent challenges in the design of freeze-drying process for monoclonal antibodies

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Recent advances and persistent challenges in the design of freeze-drying process for monoclonal antibodies

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Ce document a été publié dans

Résumé en anglais

Mots clés en anglais

URI

DOI

Unités de recherche