Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
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

Join For Free

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 2,900+ scientific posters on ePosters
  • More than 4,200+ 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

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
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
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
Therapy Halts Progression of Lou Gehrig’s Disease
Researchers at Oregon State University announced today that they have essentially stopped the progression of amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, for nearly two years in one type of mouse model used to study the disease – allowing the mice to approach their normal lifespan.
New Mechanism of Antitumor Action Identified
A team of UAB researchers and collaborators from the Catalan biotech company Ability Pharmaceuticals (UAB Research Park), have described a new mechanism of anti-tumour action, identified during the study and development of the new drug ABTL0812.
Experimental Combination Surprises with Anti-HIV Effectiveness
A compound developed to protect the nervous system from HIV surprised researchers by augmenting the effectiveness of an investigational antiretroviral drug beyond anything expected.
UTSW Researchers Identifies How Drugs Alter Pancreatic Cancer Cells
The findings were published in Cell Reports.
Researchers Identify Process that Causes Chronic Neonatal Lung Disease
Study determines how the NLRP3 inflammasome activates the protein Interleukin 1 beta.
Dengue Vaccine Enters Phase 3 Trial
Investigational vaccine to prevent ‘breakbone fever’ developed at NIH.
Trying to Conceive Soon After a Pregnancy Loss May Increase Chances of Live Birth
NIH study finds no reason for delaying pregnancy attempts after a loss without complications.
BRCA1 Deficiency Increases the Sensitivity of Ovarian Cancer Cells to Auranofin
An anti-rheumatic drug could improve the prognosis for ovarian cancer patients exhibiting a deficiency of the DNA repair protein BRCA1, a study suggests.
Shingles Vaccine Helps Protect Older Patients with End-stage Renal Disease
Kaiser Permanente study advances knowledge about safety and effectiveness of vaccine commonly given to older adults.
AMRI Acquires Whitehouse Laboratories
Strategically extends AMRI's analytical offerings in rapidly expanding area of outsourcing services.
Scroll Up
Scroll Down
SELECTBIO

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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!