Corporate Banner
Satellite Banner
Stem Cells, Cellular Therapy & Biobanking
>
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Cellular Dynamics Announces the Production of Human iPSC Lines Under cGMP Conditions

Published: Thursday, January 17, 2013
Last Updated: Thursday, January 17, 2013
Bookmark and Share
cGMP iPSC lines enable the possible use of iPSC-derived human cells within a clinical setting.

Cellular Dynamics International, Inc. (CDI) announced that it is producing human iPSC master cell banks from five individual donors under current Good Manufacturing Practices (cGMPs). Manufacturing human iPSCs and ultimately human cells under cGMPs enables the possible use of iPSC-derived human cells within a clinical setting.

"Reaching this manufacturing milestone is a critical step toward the development and manufacture of human cell-based therapies based on iPSC technology," said Robert Palay, CDI CEO.  "We believe that CDI's tight quality controls coupled with our ability to manufacture billions of cells per day will enable iPSC technology to be incorporated in cell therapeutic applications, which will need a steady and large source of high quality human cells."

CDI's iPSC reprogramming and differentiation processes are highly controlled with strong quality management systems, robust operating procedures, and well-defined raw materials. CDI produces iPSCs using a proprietary episomal reprogramming process established by CDI founder James Thomson, Ph.D. and Junying Yu, Ph.D., at the University of Wisconsin and by Amanda Mack at CDI, whereby iPSCs can be created from somatic cells without the integration of foreign DNA into the genome, and with the use of only fully defined, animal-free, and feeder-free conditions. A discussion of CDI's cGMP manufacturing process will occur at the Scale-Up and Manufacturing of Cell-Based Therapies II Conference on Jan. 21-23 in San Diego.

CDI plans to create cGMP human iPSC master cell banks from blood samples drawn from five individuals who have been previous blood or tissue donors. The company is selecting the individuals based on the donor's HLA (human leukocyte antigen) profile, choosing those donors whose HLA profile makes their cells or tissues most amenable for donation to unrelated recipients. HLA matching is important in tissue and organ transplants, as matched cells and tissues are much less likely to be rejected by a recipient's body.

"We're strategically selecting our first five donors based on their HLAs to create the largest possible pool of potential recipients in the general population," said Emile Nuwaysir, chief operating officer of CDI.   "We expect to expand this coverage in the future by selecting additional donors to create master cell banks with a beneficial genetic match to the majority of the North American population.  Many scientists believe that iPSC-based cell therapies that employ this HLA matching strategy should result in reduced use of immunosuppressive drugs and be better tolerated by patients.  We are excited to take a leading role in this very important area as iPS cells begin to make their migration into cellular therapeutics."


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Cord Blood Registry and CDI Announce Collaboration
Collaboration to reprogram newborn stem cells into induced pluripotent stem cells.
Wednesday, January 14, 2015
Using iPSC-derived Cells to Coat Blood Vessels in Kidney Scaffolds
Cellular Dynamics and Northwestern University take first steps toward rebuilding an organ using manufactured human cells.
Tuesday, November 18, 2014
Cellular Dynamics International Reports Third Quarter 2014 Financial Results
Cellular Dynamics International, Inc. reported financial results for the third quarter and nine months ended September 30, 2014.
Tuesday, November 11, 2014
Cellular Dynamics Awarded $1.2 M NEI Contract
Contract will see company develop patient-derived stem cells in gear-up for age-related macular degeneration trial.
Tuesday, October 28, 2014
Cellular Dynamics Awarded NEI Contract
Contract awarded for the development of patient-derived stem cells in gear-up for age-related macular degeneration trial.
Monday, October 27, 2014
Cellular Dynamics Awarded U.S. Patent
Patent strengthens CDI’s position as leading manufacturer of human cells for research and clinical applications.
Friday, August 29, 2014
Cellular Dynamics Awarded Pluripotent Stem Cells Patents
Patents secure CDI’s position as leading manufacturer of human cells from most common, easily accessible donor source for research, drug discovery and regenerative medicine.
Thursday, July 10, 2014
Cellular Dynamics Q4 Revenues Increase 41%
Cellular Dynamics International, Inc. reported financial results for the fourth quarter and for the fiscal year ended December 31, 2013.
Tuesday, March 11, 2014
Cellular Dynamics Signs Agreement with Nestlé Institute of Health Sciences
Agreement will see company to supply iCell® and MyCell® products for nutritional research.
Wednesday, January 08, 2014
The Hamner Institutes and Cellular Dynamics Collaborate
The parties will develop predictive in vitro screening assays for chemical, environmental and pharmaceutical toxicology assessments.
Monday, December 09, 2013
Jain Foundation Signs Agreement with Cellular Dynamics
Company will create iPSC lines from patients with muscular dystrophies for use as disease models for basic research and drug discovery.
Wednesday, December 04, 2013
CDI Reports Third Quarter 2013 Financial Results
Revenues more than double.
Wednesday, November 13, 2013
Cellular Dynamics Receives Formal Notice of Grant Award (NGA) for $16 Million Stem Cell Banking Project
NGA signifies entry into a definitive agreement and initiation of funding.
Tuesday, November 05, 2013
Cellular Dynamics Issued U.S. Patent
The patent relates to the method by which induced pluripotent stem cells are differentiated into the diverse types of endothelial and hematopoietic cells.
Thursday, October 17, 2013
Cellular Dynamics International Announces Closing of Initial Public Offering
Company announced the closing of its previously announced initial public offering of 3,846,000 shares of common stock at a price to the public of $12.00 per share.
Wednesday, July 31, 2013
Scientific News
Crucial for Stem Cell Survival Protein Identified Using Editing Tool CRISPR
A team of University of Wisconsin-Madison engineers has identified a protein that is integral to the survival and self-renewal processes of human pluripotent stem cells (hPSC).
A Gene-Sequence Swap Using CRISPR to Cure Haemophilia
For the first time chromosomal defects responsible for hemophilia have been corrected in patient-specific iPSCs using CRISPR-Cas9 nucleases
Access Denied: Leukemia Thwarted by Cutting Off Link to Environmental Support
A new study reveals a protein’s critical – and previously unknown -- role in the development and progression of acute myeloid leukemia (AML), a fast-growing and extremely difficult-to-treat blood cancer.
New Weapon in the Fight Against Blood Cancer
This strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
Scientists Create CRISPR/Cas9 Knock-In Mutations in Human T Cells
In a project spearheaded by investigators at UC San Francisco, scientists have devised a new strategy to precisely modify human T cells using the genome-editing system known as CRISPR/Cas9.
Zebrafish Reveal Drugs that may Improve Bone Marrow Transplant
Compounds boost stem cell engraftment; could allow more matches for patients with cancer and blood diseases.
New Material Forges the Way for 'Stem Cell Factories'
Researchers have discovered the first fully synthetic substrate with potential to grow billions of stem cells. The researchcould forge the way for the creation of 'stem cell factories' - the mass production of human embryonic (pluripotent) stem cells.
Liver Regrown from Stem Cells
Scientists have repaired a damaged liver in a mouse by transplanting stem cells grown in the laboratory.
Immunotherapy Shows Promise for Myeloma
A strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
'Google Maps' for the Body
Scientists have revealed research that uses previously top-secret technology to zoom through the human body down to the level of a single cell that could be a game-changer for medicine.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!