Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab.

Autor: Quiñonez-Alvarado MG; Research and Development Department, Centro de Investigación Sophia S.A. de C.V, Paseo Del Norte 4896, Guadalajara Technology Park, Zapopan, 45010, Jalisco, Mexico., Chávez-Hurtado P; Research and Development Department, Centro de Investigación Sophia S.A. de C.V, Paseo Del Norte 4896, Guadalajara Technology Park, Zapopan, 45010, Jalisco, Mexico., Caro-Palomera JC; Research and Development Department, Centro de Investigación Sophia S.A. de C.V, Paseo Del Norte 4896, Guadalajara Technology Park, Zapopan, 45010, Jalisco, Mexico., Niño-Trejo OL; Research and Development Department, Centro de Investigación Sophia S.A. de C.V, Paseo Del Norte 4896, Guadalajara Technology Park, Zapopan, 45010, Jalisco, Mexico., Jiménez-Dolores JI; Research and Development Department, Centro de Investigación Sophia S.A. de C.V, Paseo Del Norte 4896, Guadalajara Technology Park, Zapopan, 45010, Jalisco, Mexico., Muñoz-Villegas P; Regional Medical Affairs Department, Laboratorios Sophia S.A. de C.V, Paseo Del Norte 5255, Guadalajara Technology Park, Zapopan, 45010, Jalisco, Mexico., Baiza-Durán L; Regional Medical Affairs Department, Laboratorios Sophia S.A. de C.V, Paseo Del Norte 5255, Guadalajara Technology Park, Zapopan, 45010, Jalisco, Mexico., Quintana-Hau JD; Research and Development Department, Centro de Investigación Sophia S.A. de C.V, Paseo Del Norte 4896, Guadalajara Technology Park, Zapopan, 45010, Jalisco, Mexico. Electronic address: juan.quintana@sophia.com.mx.
Jazyk: angličtina
Zdroj: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2023 Nov; Vol. 84, pp. 101711. Date of Electronic Publication: 2023 Sep 23.
DOI: 10.1016/j.biologicals.2023.101711
Abstrakt: PRO-169 is an anti-VEGF monoclonal antibody developed by Laboratorios Sophia that shares its sequence with Bevacizumab (BVZ); though, PRO-169 is intended for intravitreal administration. In this study, analytical characterization showed that PRO-169 had glycosylation differences in comparison to BVZ reference product (RP); since it had more content of G1F, G2F, sialic acid and high mannose. Further investigation was performed to evaluate if differences between both products would affect the efficacy and safety profile of PRO-169. PRO-169 had no alteration in its in vitro biological activity; moreover, no cytotoxicity or immunogenicity concerns should be expected as demonstrated by different orthogonal methods at analytical, in vitro and in vivo assays. These results support moving to the clinical testing of PRO-169 since no major complications will be expected with its clinical use for the treatment of ophthalmic diseases.
Competing Interests: Declaration of competing interest All authors are employees of Centro de Investigación de Sophia S.A. de C.V. or Laboratorios Sophia S.A. de C.V. which are developing PRO-169. The authors declare no proprietary interest in PRO-169. Patent application MX/a/2017/003667 was submitted on 2017-03-17, by Laboratorios Sophia SA de CV. Publication date: 2018-10-19. IMPI.
(Copyright © 2023. Published by Elsevier Ltd.)
Databáze: MEDLINE
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