Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

FDA Agreement on Mesoblast’s Use of Singapore Manufacturing Facility for MPCs Clinical Trial Production

Published: Tuesday, May 21, 2013
Last Updated: Tuesday, May 21, 2013
Bookmark and Share
New facility will support product delineation strategies, increase geographical reach, and reduce risk of single site reliance.

Mesoblast Limited has announced that United States Food and Drug Administration (FDA) is in agreement for Mesoblast to supply its proprietary Mesenchymal Precursor Cells (MPCs) for clinical trials in the United States under Investigational New Drug (IND) protocols, from Lonza's contract manufacturing facility in Singapore, in addition to its United States facility.

This follows the successful transfer of Mesoblast's MPC manufacturing process from the United States to the Singapore facilities of its contract manufacturer Lonza.

As the clinical indications pursued under IND by Mesoblast continue to broaden, particularly using intravenous delivery of MPCs for diseases of excessive inflammation and immunity, the Singapore facility will serve to support strategies for new product delineation.

As previously announced, the FDA has agreed that Mesoblast's manufacturing process is acceptable for Phase 3 clinical supplies. Mesoblast plans to use product manufactured in the Singapore plant in global Phase 3 trials.

Mesoblast Chief Executive Professor Silviu Itescu said: “Having multiple geographic sites to manufacture our MPC products to FDA compliance is an integral part of Mesoblast’s corporate strategy for product delineation, and offsets risks of single site dependence.

Itescu continued, “We anticipate that our operations in Singapore, where we maintain exclusive access to Lonza's manufacturing facilities for allogeneic cells, will expand in line with our growth in global capacity requirements for product supply, new product lines, and partnering strategies.”

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 2,800+ scientific posters on ePosters
  • More Than 4,000+ 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 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

Pharmaceutical Executive Joins Mesoblast as Chief Financial Officer
Appointment of Mr Paul Hodgkinson as Company’s Chief Financial Officer.
Tuesday, August 26, 2014
Mesoblast Receives FDA Clearance for Phase 2 Trial of MPCs in Active RA Patients
In addition, a second Phase 2 trial of MPCs as a first-line biologic treatment for active RA is planned to commence in Europe in 1H 2013.
Thursday, May 16, 2013
Mesoblast Completes A$170m Private Placement
Company now has cash reserves of approximately A$332 million.
Tuesday, March 19, 2013
Mesoblast Reports Half-Year 2013 Financial Results
Provides strategic update on key areas of product development.
Tuesday, February 12, 2013
Key Mesenchymal Precursor Cell Patents Granted in United States and China
New granted claims confer exclusive, long-term commercial rights in the world's largest established and emerging healthcare markets.
Friday, February 08, 2013
New Teva Representative Joins Mesoblast Board Of Directors
Appointment of Dr Ben-Zion Weiner as a non-executive Director of Mesoblast.
Monday, October 22, 2012
Mesoblast Provides Corporate Strategy for Product Development to Treat Neurologic Conditions
Exclusive commercial rights to develop neuroregenerative dental pulp stem cells.
Tuesday, June 12, 2012
Mesoblast Receives FDA Clearance for Phase 2 Clinical Trial of Proprietary Stem Cell Therapy in Type 2 Diabetes
Trial will be randomized, placebo-controlled to evaluate safety and effectiveness over 3 months of a single intravenous injection of one of three progressively increasing MPC doses in 60 Type 2 diabetes patients with elevated blood glucose levels.
Tuesday, May 08, 2012
Intervertebral Disc Repair Phase 2 Trial Update
Rapid patient accrual, enrolment reaches half way mark positive preclinical study results published in premier neurosurgical journal.
Wednesday, April 18, 2012
Mesoblast Half-Year Results
Strong financial position underpins company’s ability to deliver in increased value from broadened range of stem cell therapeutics.
Tuesday, February 28, 2012
Half Year Results - Mesoblast Posts Strong Cash Balance
Company reports cash reserves of $241 million for the 2012 financial half year reporting period.
Tuesday, February 28, 2012
Mesoblast Presented Positive Phase 2 Results at AHA
Revascor™ anticipated to progress to Phase 3 trial in first half of 2012.
Friday, November 18, 2011
Mesoblast Cleared to Begin First Phase 2 Clinical Trial for Eye Diseases
Mesoblast receives regulatory clearance to begin Phase 2 trial for wet Age-related Macular Degeneration.
Thursday, October 27, 2011
Mesoblast Receives Clearance to Begin First European Trial of Allogeneic or ‘Off-The-Shelf’ Stem Cell Treatment for Heart Attacks
Company receives clearance to begin Phase 2 clinical trial for Revascor™ in conjunction with angioplasty and stent procedures.
Tuesday, September 06, 2011
Single Dose of Proprietary Adult Stem Cells Regenerates Damaged Pancreas
Stem cell treatment induced two-fold increase in total numbers of pancreatic islets, and increase in insulin-producing beta cells.
Monday, December 21, 2009
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
Promising Drug Combination for Advanced Prostate Cancer
A new drug combination may be effective in treating men with metastatic prostate cancer. Preliminary results of this new approach are encouraging and have led to an ongoing international study being conducted in 196 hospitals worldwide.
A Cellular Symphony Responsible for Autoimmune Disease
Broad Institute researchers have used a novel approach to increase our understanding of the immune system as a whole.
When it Comes to Breast Cancer, Common Pigeon is No Bird Brain
If pigeons went to medical school and specialized in pathology or radiology, they’d be pretty good at distinguishing digitized microscope slides and mammograms of normal vs. cancerous breast tissue, a new study has found.
Editing of LIMS Data Made Faster and More Efficient in Matrix Gemini
The latest version of the Matrix Gemini LIMS (Laboratory Information Management System) from Autoscribe Informatics now provides faster and more efficient editing of LIMS data by eliminating the need for a second editing screen.
University of Edinburgh, Selcia Achieve Key Milestones in Drug Development Program
Scientists from the University of Edinburgh, working with Selcia, have successfully passed the 20-month milestone targets of a 30-month Wellcome Trust SDDi £2.5 million project to design novel treatments for sleeping sickness.
Red Clover Genome to Help Restore Sustainable Farming
The Genome Analysis Centre (TGAC) in collaboration with IBERS, has sequenced and assembled the DNA of red clover to help breeders improve the beneficial traits of this important forage crop.
How a Genetic Locus Protects Adult Blood-Forming Stem Cells
Mammalian imprinted Gtl2 protects adult hematopoietic stem cells by restricting metabolic activity in the cells' mitochondria.
Genetic Basis of Fatal Flu Side Effect Discovered
A group of people with fatal H1N1 flu died after their viral infections triggered a deadly hyperinflammatory disorder in susceptible individuals with gene mutations linked to the overactive immune response, according to a recent study.
New Tech Vastly Improves CRISPR/Cas9 Accuracy
A new CRISPR/Cas9 technology developed by scientists at UMass Medical School is precise enough to surgically edit DNA at nearly any genomic location, while avoiding potentially harmful off-target changes typically seen in standard CRISPR gene editing techniques.
Scroll Up
Scroll Down
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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos