Literature DB >> 31053443

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

Abla A Creasey1, Glyn Stacey2, Kapil Bharti3, Yoji Sato4, Anthony Lubiniecki2.   

Abstract

Entities:  

Keywords:  Biologics license application; Cell therapy; Roadmap; Stem cells

Mesh：

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Year:  2019        PMID： 31053443      PMCID： PMC7476766          DOI： 10.1016/j.biologicals.2019.03.007

Source DB:  PubMed          Journal:  Biologicals        ISSN： 1045-1056            Impact factor:   1.856


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  1 in total

1.  Report of the international conference on manufacturing and testing of pluripotent stem cells.

Authors:  Stewart Abbot; Francisca Agbanyo; Jan-Eric Ahlfors; Behnam A Baghbaderani; Shirley Bartido; Kapil Bharti; Carl Burke; Bjorn Carlsson; Joy Cavagnaro; Abla Creasey; David DiGiusto; Kathy Francissen; Andrew Gaffney; Christopher Goldring; Thorsten Gorba; Elwyn Griffiths; Tadaaki Hanatani; Takao Hayakawa; Tatsuo Heki; Karin Hoogendoorn; Shin Kawamata; Hironobu Kimura; Agnete Kirkeby; Ivana Knezevic; Jane Lebkowski; Stephen Lin; Shen Lin-Gibson; Anthony Lubiniecki; Orla O'Shea; Martin Pera; John Petricciani; Gary Pigeau; Anthony Ratcliffe; Yoji Sato; Gerald G Schumann; William Shingleton; Glyn Stacey Chair; Stephen Sullivan; Clive N Svendsen; Jean-Hugues Trouvin; Joris Vandeputte; Bao-Zhu Yuan; Kathryn Zoon
Journal:  Biologicals       Date:  2018-08-24       Impact factor: 1.856
  1 in total
  5 in total

Review 1.  Regulatory considerations for developing a phase I investigational new drug application for autologous induced pluripotent stem cells-based therapy product.

Authors:  Balendu Shekhar Jha; Mitra Farnoodian; Kapil Bharti
Journal:  Stem Cells Transl Med       Date:  2020-09-18       Impact factor: 6.940

Review 2.  Translating stem cell research into development of cellular drugs-a perspective from manufacture of stem cell products and CMC considerations.

Authors:  Yu Alex Zhang; Glyn N Stacey
Journal:  Cell Prolif       Date:  2022-02-14       Impact factor: 8.755

3.  Perspectives on the cost of goods for hPSC banks for manufacture of cell therapies.

Authors:  Jung-Hyun Kim; Eihachiro Kawase; Kapil Bharti; Ohad Karnieli; Yuji Arakawa; Glyn Stacey
Journal:  NPJ Regen Med       Date:  2022-09-29

Review 4.  Neuronal cell-based medicines from pluripotent stem cells: Development, production, and preclinical assessment.

Authors:  Yun Sun; Lin Feng; Lingmin Liang; Glyn N Stacey; Chaoqun Wang; Yukai Wang; Baoyang Hu
Journal:  Stem Cells Transl Med       Date:  2021-11       Impact factor: 6.940

Review 5.  Outer Retinal Cell Replacement: Putting the Pieces Together.

Authors:  Allison L Ludwig; David M Gamm
Journal:  Transl Vis Sci Technol       Date:  2021-08-12       Impact factor: 3.283
  5 in total

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