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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...
Autores principales: | Wright, Teresa, Li, Aiqun, Lotterhand, Jason, Graham, Anne-Renee, Huang, Yan, Avila, Nancy, Pan, Jing |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2018
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Materias: | |
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 |
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