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

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 2,500+ 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

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
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
LaVision BioTec Reports on the Neuro Research on the Human Brain After Trauma
Company reports on the work of Dr Ali Ertürk from the Institute for Stroke and Dementia Research at LMU Munich.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Less May Be More in Slowing Cholera Epidemics
Mathematical model shows more cases may be prevented and more lives saved when using one dose of cholera vaccine instead of recommended two doses.
Investigating the Vape
Expert independent review concludes that e-cigarettes have potential to help smokers quit.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Researchers Discover Synthesis of a New Nanomaterial
Interdisciplinary team creates biocomposite for first time using physiological conditions.
Poor Survival Rates in Leukemia Linked to Persistent Genetic Mutations
For patients with an often-deadly form of leukemia, new research suggests that lingering cancer-related mutations – detected after initial treatment with chemotherapy – are associated with an increased risk of relapse and poor survival.
Flu Remedies Help Combat E. coli Bacteria
Physiologists from the University of Zurich have now discovered why the intestinal bacterium Escherichia coli (E. coli) multiplies heavily and has an inflammatory effect.
Marijuana Genome Unraveled
A study by Canadian researchers is providing a clearer picture of the evolutionary history and genetic organization of cannabis, a step that could have agricultural, medical and legal implications for this valuable crop.
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!