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Literature DB >> 27054995

Quality cell therapy manufacturing by design.

Yonatan Y Lipsitz¹, Nicholas E Timmins², Peter W Zandstra^1,2,3,4.

Abstract

Transplantation of live cells as therapeutic agents is poised to offer new treatment options for a wide range of acute and chronic diseases. However, the biological complexity of cells has hampered the translation of laboratory-scale experiments into industrial processes for reliable, cost-effective manufacturing of cell-based therapies. We argue here that a solution to this challenge is to design cell manufacturing processes according to quality-by-design (QbD) principles. QbD integrates scientific knowledge and risk analysis into manufacturing process development and is already being adopted by the biopharmaceutical industry. Many opportunities to incorporate QbD into cell therapy manufacturing exist, although further technology development is required for full implementation. Linking measurable molecular and cellular characteristics of a cell population to final product quality through QbD is a crucial step in realizing the potential for cell therapies to transform healthcare.

Mesh：

Year: 2016 PMID： 27054995 DOI： 10.1038/nbt.3525

Source DB: PubMed Journal: Nat Biotechnol ISSN： 1087-0156 Impact factor: 54.908

42 in total

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Journal: Cell Stem Cell Date: 2012-02-03 Impact factor: 24.633

Review 2. Transforming the promise of pluripotent stem cell-derived cardiomyocytes to a therapy: challenges and solutions for clinical trials.

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3. Immunological characterization of multipotent mesenchymal stromal cells--The International Society for Cellular Therapy (ISCT) working proposal.

Authors: Mauro Krampera; Jacques Galipeau; Yufang Shi; Karin Tarte; Luc Sensebe
Journal: Cytotherapy Date: 2013-04-17 Impact factor: 5.414

4. Factorial experimental design for the culture of human embryonic stem cells as aggregates in stirred suspension bioreactors reveals the potential for interaction effects between bioprocess parameters.

Authors: Megan M Hunt; Guoliang Meng; Derrick E Rancourt; Ian D Gates; Michael S Kallos
Journal: Tissue Eng Part C Methods Date: 2013-07-16 Impact factor: 3.056

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Authors: Xiaoli Chen; Allen Chen; Tsung Liang Woo; Andre B H Choo; Shaul Reuveny; Steve K W Oh
Journal: Stem Cells Dev Date: 2010-09-10 Impact factor: 3.272

6. Distinct metabolic flow enables large-scale purification of mouse and human pluripotent stem cell-derived cardiomyocytes.

Authors: Shugo Tohyama; Fumiyuki Hattori; Motoaki Sano; Takako Hishiki; Yoshiko Nagahata; Tomomi Matsuura; Hisayuki Hashimoto; Tomoyuki Suzuki; Hiromi Yamashita; Yusuke Satoh; Toru Egashira; Tomohisa Seki; Naoto Muraoka; Hiroyuki Yamakawa; Yasuyuki Ohgino; Tomofumi Tanaka; Masatoshi Yoichi; Shinsuke Yuasa; Mitsushige Murata; Makoto Suematsu; Keiichi Fukuda
Journal: Cell Stem Cell Date: 2012-11-15 Impact factor: 24.633

7. Improving efficiency of human pluripotent stem cell differentiation platforms using an integrated experimental and computational approach.

Authors: Joshua A Selekman; Amritava Das; Nicholas J Grundl; Sean P Palecek
Journal: Biotechnol Bioeng Date: 2013-07-09 Impact factor: 4.530

8. Manufacturing validation of biologically functional T cells targeted to CD19 antigen for autologous adoptive cell therapy.

Authors: Daniel Hollyman; Jolanta Stefanski; Mark Przybylowski; Shirley Bartido; Oriana Borquez-Ojeda; Clare Taylor; Raymond Yeh; Vanessa Capacio; Malgorzata Olszewska; James Hosey; Michel Sadelain; Renier J Brentjens; Isabelle Rivière
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Authors: Payel Datta; Robert J Linhardt; Susan T Sharfstein
Journal: Biotechnol Bioeng Date: 2013-02-04 Impact factor: 4.530

10. High-throughput fingerprinting of human pluripotent stem cell fate responses and lineage bias.

Authors: Emanuel J P Nazareth; Joel E E Ostblom; Petra B Lücker; Shreya Shukla; Manuel M Alvarez; Steve K W Oh; Ting Yin; Peter W Zandstra
Journal: Nat Methods Date: 2013-10-20 Impact factor: 28.547

51 in total

Review 1. Manufacturing Cell Therapies Using Engineered Biomaterials.

Authors: Amr A Abdeen; Krishanu Saha
Journal: Trends Biotechnol Date: 2017-07-12 Impact factor: 19.536

2. Effect of Cryopreservation on Autologous Chimeric Antigen Receptor T Cell Characteristics.

Authors: Sandhya R Panch; Sandeep K Srivastava; Nasha Elavia; Andrew McManus; Shutong Liu; Ping Jin; Steven L Highfill; Xiaobai Li; Pradeep Dagur; James N Kochenderfer; Terry J Fry; Crystal L Mackall; Daniel Lee; Nirali N Shah; David F Stroncek
Journal: Mol Ther Date: 2019-05-30 Impact factor: 11.454

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Authors: Mason A Chilmonczyk; Peter A Kottke; Hazel Y Stevens; Robert E Guldberg; Andrei G Fedorov
Journal: Biotechnol Bioeng Date: 2018-11-06 Impact factor: 4.530

Review 4. A New Chapter for Mesenchymal Stem Cells: Decellularized Extracellular Matrices.

Authors: Yagiz Anasiz; Riza Koksal Ozgul; Duygu Uckan-Cetinkaya
Journal: Stem Cell Rev Rep Date: 2017-10 Impact factor: 5.739

Review 5. Bronchopulmonary dysplasia.

Authors: Bernard Thébaud; Kara N Goss; Matthew Laughon; Jeffrey A Whitsett; Steven H Abman; Robin H Steinhorn; Judy L Aschner; Peter G Davis; Sharon A McGrath-Morrow; Roger F Soll; Alan H Jobe
Journal: Nat Rev Dis Primers Date: 2019-11-14 Impact factor: 52.329

Review 6. Biomanufacturing for clinically advanced cell therapies.

Authors: Ayesha Aijaz; Matthew Li; David Smith; Danika Khong; Courtney LeBlon; Owen S Fenton; Ronke M Olabisi; Steven Libutti; Jay Tischfield; Marcela V Maus; Robert Deans; Rita N Barcia; Daniel G Anderson; Jerome Ritz; Robert Preti; Biju Parekkadan
Journal: Nat Biomed Eng Date: 2018-06-11 Impact factor: 25.671

7. Engineered Ovarian Cancer Cell Lines for Validation of CAR T Cell Function.

Authors: Claire E Repellin; Priya Ganesan; Javier F Alcudia; Haritha K Duggireddy Lakshmireddy; Puja Patel; Lucia Beviglia; Harold S Javitz; Lidia Sambucetti; Parijat Bhatnagar
Journal: Adv Biosyst Date: 2019-11-29

8. In vivo evaluation of bioprinted cardiac patches composed of cardiac-specific extracellular matrix and progenitor cells in a model of pediatric heart failure.

Authors: Donald Bejleri; Matthew J Robeson; Milton E Brown; Jervaughn Hunter; Joshua T Maxwell; Benjamin W Streeter; Olga Brazhkina; Hyun-Ji Park; Karen L Christman; Michael E Davis
Journal: Biomater Sci Date: 2022-01-18 Impact factor: 6.843

Review 9. The evolution of commercial drug delivery technologies.

Authors: Ava M Vargason; Aaron C Anselmo; Samir Mitragotri
Journal: Nat Biomed Eng Date: 2021-04-01 Impact factor: 25.671

Review 10. Single-Use Bioreactors for Human Pluripotent and Adult Stem Cells: Towards Regenerative Medicine Applications.

Authors: Diogo E S Nogueira; Joaquim M S Cabral; Carlos A V Rodrigues
Journal: Bioengineering (Basel) Date: 2021-05-17