Nonclinical comparability studies of recombinant human arylsulfatase A addressing manufacturing process changes

Recombinant human arylsulfatase A (rhASA) is in clinical development for the treatment of patients with metachromatic leukodystrophy (MLD). Manufacturing process changes were introduced to improve robustness and efficiency, resulting in higher levels of mannose-6-phosphate and sialic acid in post-ch...

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Detalles Bibliográficos
Autores principales: Wright, Teresa, Li, Aiqun, Lotterhand, Jason, Graham, Anne-Renee, Huang, Yan, Avila, Nancy, Pan, Jing
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2018
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5908175/
https://www.ncbi.nlm.nih.gov/pubmed/29672630
http://dx.doi.org/10.1371/journal.pone.0195186

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5908175/
https://www.ncbi.nlm.nih.gov/pubmed/29672630
http://dx.doi.org/10.1371/journal.pone.0195186

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