Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Life Technologies' OpTmizer™ T-Cell Growth Medium Receives FDA Clearance

Published: Friday, September 28, 2012
Last Updated: Friday, September 28, 2012
Bookmark and Share
Offers cost- and time-saving advantages and is now cleared as a Class II medical device.

Life Technologies Corporation has announced that it has received FDA 510(k) clearance for its OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium - a reagent that is now cleared as a Class II medical device and offers cost- and time-saving advantages for transitioning studies from the research bench to clinical trials.

The OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium is intended for human ex vivo (outside the body) tissue and cell culture processing application.

This means it is designed to efficiently grow large numbers of potentially therapeutic T-cells, which have demonstrated promise in clinical studies as an effective treatment for diseases including cancer, infectious diseases such as AIDS, and autoimmune disorders.

"We are very pleased to learn of Life Technologies' successful outcome in achieving its FDA 510(k) regulatory clearance for its OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium, and we value the close working relationship we have established with Life Tech," said Neil K. Warma, President & CEO of Opexa Therapeutics, Inc.

Warma continued, "The receipt of 510(k) status for OpTmizer CTS T-cell expansion media simplifies the regulatory path for Opexa as we continue the development of Tcelna™, a T-cell immunotherapy for the treatment of patients with multiple sclerosis."

As a product that is manufactured following GMP requirements in an ISO 9001/13485 certified facility, OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium provides a xenofree formulation, containing defined components that can help reduce variability during the development of T-cell therapies.

The ability to document manufacturing process details, quality control testing and component traceability streamlines the review process when submitting Investigational New Drug (IND) applications to the FDA as required for clinical trial initiation.

Its effectiveness in rapid T-cell expansion at high cell density can reduce media usage, which results in end-user cost savings.

OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium is currently being used in multiple clinical trials in the United States. It complements other Life Technologies Cell Therapy Systems (CTS™) branded products that have previously received 510(k) clearance by the FDA.

They include: AIM V® Medium, DMEM, KnockOut™ SR Medium, KnockOut™ SR XenoFree Medium and StemPro MSC SFM CTS.

The company's portfolio of solutions addresses a wide range of cell types and procedures including the isolation, expansion, differentiation and characterization of cells.

"The availability of validated tools for use in clinical trials is one of the key steps to realizing the potential for stem cell therapy," said Chris Armstrong, Ph.D, General Manager and Vice President of Primary and Stem Cell Systems at Life Technologies.

Armstrong continued, "The FDA's clearance of our product for culturing T-cells is an important step in that direction and supports our commitment to offering our customers leading products that drive their translational research."


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.


Scientific News
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Computerized Flexible Needles Prove Themselves in Biological Tissue
The advantage of the system is that you can avoid obstacles with the needles or critical tissues and that the system during the insertion of the needle in real time can adjust the path if, for example, the tissue deforms.
DARWIN 2 24-week Monotherapy Data in RA Confirm Previous Results
Safety profile in DARWIN 2 consistent with previous filgotinib RA studies.
Researchers Publish Landmark “Basket Study”
Researchers from Memorial Sloan Kettering Cancer Center (MSK) have announced results from the first published basket study, a new form of clinical trial design that explores responses to drugs based on the specific mutations in patients’ tumors rather than where their cancer originated.
Agricultural Intervention Improves HIV Outcomes
A multifaceted farming intervention can reduce food insecurity while improving HIV outcomes in patients in Kenya, according to a randomized, controlled trial led by researchers at UC San Francisco.
Overdose of Vitamin D in Teenagers May Lead to Increased Cholesterol Levels
Dosing obese teens with vitamin D shows no benefits for their heart health or diabetes risk, and could have the unintended consequences of increasing cholesterol and fat-storing triglycerides. These are the latest findings in a series of Mayo Clinic studies in childhood obesity.
Phase 2 Trials Underway for New Single Dose Malaria Treatment
The new drug, which prevents the malaria parasite from reproducing and spreading, is now undergoing Phase II clinical trials in humans.
Promising Drug for Parkinson's Disease
A drug which has already been in use for decades to treat liver disease could be an effective treatment to slow down progression of Parkinson’s disease, scientists from the University of Sheffield have discovered.
Benefits of Early Antiretroviral Therapy in HIV Infection
Scientists have explored the clinical importance of starting treatment early in individuals suffering with HIV.
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!