A strategic road map to filing a Biologics License Application for a pluripotent stem cell derived therapeutic product-Reference-Cited by-同舟云学术

A strategic road map to filing a Biologics License Application for a pluripotent stem cell derived therapeutic product

Published:2019-05 Issue: Volume:59 Page:68-71
ISSN:1045-1056
Container-title:Biologicals
language:en
Short-container-title:Biologicals

Author:

Creasey Abla A.,Stacey Glyn,Bharti Kapil,Sato Yoji,Lubiniecki Anthony

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference3 articles.

1. Report of the international conference on manufacturing and testing of pluripotent stem cell;Abbot;Biologicals,2018

2. Content and review of Chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs),2008

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