Quality cell therapy manufacturing by design

Adoptive cellular therapy: A race to the finish line

(2015) Carl H. June et al.   Science Translational Medicine

Transforming the Promise of Pluripotent Stem Cell-Derived Cardiomyocytes to a Therapy: Challenges and Solutions for Clinical Trials

(2014) Andrew B.J. Prowse et al.   CANADIAN JOURNAL OF CARDIOLOGY

MSC-Based Product Characterization for Clinical Trials: An FDA Perspective

(2014) Michael Mendicino et al.   Cell Stem Cell

Advances in umbilical cord blood manipulation—from niche to bedside

(2014) Troy C. Lund et al.   Nature Reviews Clinical Oncology

Metabolic Profiling and Flux Analysis of MEL-2 Human Embryonic Stem Cells during Exponential Growth at Physiological and Atmospheric Oxygen Concentrations

(2014) Jennifer Turner et al.   PLoS One

Defining an essential transcription factor program for naive pluripotency

(2014) S.- J. Dunn et al.   SCIENCE

Controlling Expansion and Cardiomyogenic Differentiation of Human Pluripotent Stem Cells in Scalable Suspension Culture

(2014) Henning Kempf et al.   Stem Cell Reports

Blood stem cell products: Toward sustainable benchmarks for clinical translation

(2013) Elizabeth Csaszar et al.   BIOESSAYS

Real-time monitoring and control of soluble signaling factors enables enhanced progenitor cell outputs from human cord blood stem cell cultures

(2013) Elizabeth Csaszar et al.   BIOTECHNOLOGY AND BIOENGINEERING

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

(2013) Joshua A. Selekman et al.   BIOTECHNOLOGY AND BIOENGINEERING

An 'omics approach towards CHO cell engineering

(2013) Payel Datta et al.   BIOTECHNOLOGY AND BIOENGINEERING

Selective Elimination of Human Pluripotent Stem Cells by an Oleate Synthesis Inhibitor Discovered in a High-Throughput Screen

(2013) Uri Ben-David et al.   Cell Stem Cell

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

(2013) Mauro Krampera et al.   CYTOTHERAPY

Potency assay development for cellular therapy products: an ISCT∗ review of the requirements and experiences in the industry

(2013) Christopher A. Bravery et al.   CYTOTHERAPY

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

(2013) Emanuel J P Nazareth et al.   NATURE METHODS

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

(2013) Megan M. Hunt et al.   TISSUE ENGINEERING PART C-METHODS

Rapid Expansion of Human Hematopoietic Stem Cells by Automated Control of Inhibitory Feedback Signaling

(2012) Elizabeth Csaszar et al.   Cell Stem Cell

Distinct Metabolic Flow Enables Large-Scale Purification of Mouse and Human Pluripotent Stem Cell-Derived Cardiomyocytes

(2012) Shugo Tohyama et al.   Cell Stem Cell

Managing particulates in cellular therapy

(2012) Dominic Clarke et al.   CYTOTHERAPY

A novel automated bioreactor for scalable process optimisation of haematopoietic stem cell culture

(2012) E. Ratcliffe et al.   JOURNAL OF BIOTECHNOLOGY

Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture

(2012) Elizabeth Ratcliffe et al.   Regenerative Medicine

Influence of Threonine Metabolism on S-Adenosylmethionine and Histone Methylation

(2012) N. Shyh-Chang et al.   SCIENCE

PERT: A Method for Expression Deconvolution of Human Blood Samples from Varied Microenvironmental and Developmental Conditions

(2012) Wenlian Qiao et al.   PLoS Computational Biology

Expansion of human mesenchymal stem cells on microcarriers

(2011) Christopher J. Hewitt et al.   BIOTECHNOLOGY LETTERS

Ex vivo expansion of human hematopoietic stem and progenitor cells

(2011) A. Dahlberg et al.   BLOOD

Increasing Incidence and Prevalence of the Inflammatory Bowel Diseases With Time, Based on Systematic Review

(2011) Natalie A. Molodecky et al.   GASTROENTEROLOGY

Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit

(2010) Arzu Selen et al.   AAPS Journal

Short-term exposure of umbilical cord blood CD34+ cells to granulocyte–macrophage colony-stimulating factor early in culture improves ex vivo expansion of neutrophils

(2010) Flavia Marturana et al.   CYTOTHERAPY

Efficient generation and cryopreservation of cardiomyocytes derived from human embryonic stem cells

(2010) Chunhui Xu et al.   Regenerative Medicine

Investigations into the Metabolism of Two-Dimensional Colony and Suspended Microcarrier Cultures of Human Embryonic Stem Cells in Serum-Free Media

(2010) Xiaoli Chen et al.   STEM CELLS AND DEVELOPMENT

Manufacturing Validation of Biologically Functional T Cells Targeted to CD19 Antigen for Autologous Adoptive Cell Therapy

(2009) Daniel Hollyman et al.   JOURNAL OF IMMUNOTHERAPY

Quality by design for biopharmaceuticals

(2009) Anurag S Rathore et al.   NATURE BIOTECHNOLOGY

Human Mesenchymal Stem Cells Self-Renew and Differentiate According to a Deterministic Hierarchy

(2009) Rahul Sarugaser et al.   PLoS One

Dependence of Mouse Embryonic Stem Cells on Threonine Catabolism

(2009) Jian Wang et al.   SCIENCE

Teratoma formation by human embryonic stem cells: Evaluation of essential parameters for future safety studies

(2009) Hannes Hentze et al.   Stem Cell Research

The Systematic Production of Cells for Cell Therapies

(2008) Daniel C. Kirouac et al.   Cell Stem Cell

Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use

(2008) R.J. Thomas et al.   JOURNAL OF BIOTECHNOLOGY