Manufacturing models permitting roll out/scale out of clinically led autologous cell therapies: regulatory and scientific challenges for comparability

Author:

Hourd Paul,Ginty Patrick,Chandra Amit,Williams David J.

Funder

ISCT

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics (clinical),Oncology,Immunology,Immunology and Allergy

Reference41 articles.

1. Concise review: Cell therapies: the route to widespread adoption;Foley;Stem Cells Translat Med,2012

2. Regenerative medicine bioprocessing: building a conceptual framework based on early studies;Mason;Tissue Eng,2007

3. Isolation and production of cells suitable for human therapy: challenges ahead;Ahrlund-Richter;Cell Stem Cell,2009

4. Challenges with ATMPs and how to meet them;Nature Rev Drug Discover,2010

5. Current challenges in the development of novel cell-based medicinal products;Salmikangas;Regul Rapporteur,2011

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