Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments

Cytotherapy
Joaquim VivesArnau Pla

Abstract

Along with academic and charitable organizations, transfusion centers have ventured into the stem cell field, with the aim of testing of novel cell-based therapeutics in a clinical setting for future marketing approval. The fact that quality management structures, which are required for compliance with good scientific practice regulations, were originally designed for product development in corporate environments represents a major challenge for many developers. In this Commentary, challenges that non-pharmaceutical institutions must overcome to translate cell-based products into clinical therapies will be discussed from a quality standpoint. Furthermore, our development experience for a mesenchymal stromal cell-based therapy will be shared as a case study.

References

Mar 10, 2009·Nature Biotechnology·Joe Alper
Mar 21, 2009·Expert Review of Medical Devices·Heike Mertsching, Thorsten Walles
Mar 2, 2010·Nature Reviews. Drug Discovery·UNKNOWN Committee for Advanced Therapies (CAT)Patrick Celis
Jun 1, 2011·Cell Stem Cell·Chris E P GoldringB Kevin Park
Dec 14, 2011·Stem Cell Research & Therapy·Reinhold J MedinaAlan W Stitt
May 24, 2012·Toxicology and Applied Pharmacology·Michaela E SharpeAnnamaria Rossi
Jul 24, 2012·Archives of Orthopaedic and Trauma Surgery·Roberto VélezMarius Aguirre
Mar 1, 2013·Nature·David Cyranoski
Apr 5, 2013·Science Translational Medicine·Michael A FischbachWendell A Lim
Nov 14, 2013·Stem Cells International·Luc Sensebé, Sandrine Fleury-Cappellesso

❮ Previous
Next ❯

Citations

Mar 7, 2018·Expert Review of Cardiovascular Therapy·Santiago RouraAntoni Bayes-Genis
Oct 29, 2017·Stem Cell Research & Therapy·Santiago RouraAntoni Bayes-Genis
Nov 9, 2017·Regenerative Medicine·Mariele ViganòLorenza Lazzari
Jul 17, 2019·Cell and Tissue Research·Maryam ShariatzadehSamantha Louise Wilson
Jul 19, 2017·Current Rheumatology Reports·Makeda K StephensonWarren L Grayson
Feb 14, 2017·Stem Cells Translational Medicine·Christopher R Nitkin, Tracey L Bonfield
Mar 8, 2018·Current Protocols in Stem Cell Biology·Daniel VivasJoaquim Vives
Feb 23, 2021·Frontiers in Cardiovascular Medicine·Paloma GastelurrutiaCarolina Gálvez-Montón

❮ Previous
Next ❯

Related Concepts

Related Feeds

Allogenic & Autologous Therapies

Allogenic therapies are generated in large batches from unrelated donor tissues such as bone marrow. In contrast, autologous therapies are manufactures as a single lot from the patient being treated. Here is the latest research on allogenic and autologous therapies.

CREs: Gene & Cell Therapy

Gene and cell therapy advances have shown promising outcomes for several diseases. The role of cis-regulatory elements (CREs) is crucial in the design of gene therapy vectors. Here is the latest research on CREs in gene and cell therapy.

Related Papers

Journal of Health Care Marketing
S B Fisher
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Alberto OcanaEitan Amir
North Carolina Medical Journal
C P McLaughlin, J E Littlefield
Health Services Manpower Review
M Dixon
© 2021 Meta ULC. All rights reserved