Recent advances and persistent challenges in the design of freeze-drying process for monoclonal antibodies
| dc.rights.license | open | en_US |
| hal.structure.identifier | Institut de Mécanique et d'Ingénierie [I2M] | |
| dc.contributor.author | HSEIN, Hassana | |
| hal.structure.identifier | Institut de Mécanique et d'Ingénierie [I2M] | |
| dc.contributor.author | AUFFRAY, Julie
IDREF: 256072906 | |
| hal.structure.identifier | Microbiologie Fondamentale et Pathogénicité [MFP] | |
| dc.contributor.author | NOEL, Thierry | |
| hal.structure.identifier | Institut de Mécanique et d'Ingénierie [I2M] | |
| dc.contributor.author | TCHORELOFF, Pierre | |
| dc.date.accessioned | 2023-03-16T13:14:45Z | |
| dc.date.available | 2023-03-16T13:14:45Z | |
| dc.date.issued | 2022-10-19 | |
| dc.identifier.issn | 1083-7450 | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/172332 | |
| dc.description.abstractEn | 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. | |
| dc.language.iso | EN | en_US |
| dc.subject.en | Freeze-drying | |
| dc.subject.en | Monoclonal antibodies | |
| dc.subject.en | Optimization | |
| dc.subject.en | Process parameters | |
| dc.subject.en | Product quality attributes | |
| dc.subject.en | Stability | |
| dc.title.en | Recent advances and persistent challenges in the design of freeze-drying process for monoclonal antibodies | |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1080/10837450.2022.2131818 | en_US |
| dc.subject.hal | Sciences de l'ingénieur [physics]/Matériaux | en_US |
| bordeaux.journal | Pharmaceutical Development and Technology | en_US |
| bordeaux.page | 942-955 | en_US |
| bordeaux.volume | 27 | en_US |
| bordeaux.hal.laboratories | Institut de Mécanique et d’Ingénierie de Bordeaux (I2M) - UMR 5295 | en_US |
| bordeaux.issue | 9 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.institution | Bordeaux INP | en_US |
| bordeaux.institution | CNRS | en_US |
| bordeaux.institution | INRAE | en_US |
| bordeaux.institution | Arts et Métiers | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| hal.identifier | hal-04032313 | |
| hal.version | 1 | |
| hal.date.transferred | 2023-03-16T13:14:47Z | |
| hal.export | true | |
| dc.rights.cc | Pas de Licence CC | en_US |
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