RT info:eu-repo/semantics/article
T1 Assessing Protein Content and Dimer Formation in the Bevacizumab Reference Product and Biosimilar Versions Marketed in Spain.
A1 Echezarreta López, María Magdalena
A1 Oliva Martín, Alexis Manuel
A1 Santana Mayor, Álvaro
A1 Conde Díaz, Adrían
A1 Goncalves, Joao
A1 Chow, Shein Chung
A1 Llabrés Martínez, Matías Antonio
A2 Ingeniería Química y Tecnología Farmacéutica
A2 Servicio de Apoyo a la Investigación (SEGAI)Universidad de La Laguna
Research Institute for Medicine (iMed.ULisboa.) Facultade de Farmácia, Universidad de Lisboa.
Departament of Biostatistics and Bioinformatics, Duke University School of Medicine
K1 bevacizumab
K1 biosimilar
K1 analytical similarity
K1 quality range method
K1 between- and within-batch variability
AB Background: The manufacture of biologics is a complex, controlled, and reproducible process that results in a product that meets specifications. This should be based on data from batches used to demonstrate manufacturing consistency. Ten batches of originator product (Avastin®) were analyzed over a 10-year period. Methods: The β-expectation tolerance intervals and the process capability analysis were proposed to establish the specification limits for determining the acceptance criteria of the final product from the manufacturing process. Protein concentration and dimer content were utilized as CQAs. The analytical similarity between three biosimilars authorized in Spain since 2021 (Vegzelma®, Alymsys®, and Oyavas®) and the originator product were evaluated for both CQAsusing two methods: the quality range (QR) method, based on one sample per batch, and the QRMLone,whichtakes into account the inter- and intra-batch variability of the originator product. Results: The results indicate that the two main sources of variation are under control; even the level of variability observed is close to the capability of the analytical method. The manufacturing process, therefore, continues under statistical control. Similarity is demonstrated for the bevacizumab concentration regardless of the approach used, whereas similarity is demonstrated for the dimer content for only one of the biosimilar products. Conclusions: The proposed methodologies allow for the analysis of the consistency of the manufacturing process and the variability from batch to batch.
YR 2024
FD 2024
LK http://riull.ull.es/xmlui/handle/915/40261
UL http://riull.ull.es/xmlui/handle/915/40261
LA en
DS Repositorio institucional de la Universidad de La Laguna
RD 22-dic-2024