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

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 2,600+ scientific posters on ePosters
  • More than 3,800+ 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.

Scientific News
HIV Patients Should Be Included in Early Clinical Trials of Anti-TB Drugs
Tuberculosis is the number one cause of death in HIV-infected patients in Africa and a leading cause of death in this population worldwide.
Multi-Gene Test Enables Some Breast Cancer Patients to Safely Avoid Chemotherapy
A major study is providing the best evidence to date that a 21-gene test done on the tumor can identify breast cancer patients who can safely avoid chemotherapy.
Low Dose Beta-Blockers As Effective As High Dose After a Heart Attack?
Heart attack patients live as long – or even longer – on one-quarter the suggested dose.
Antidepressants Plus Blood-Thinners Slow Down Brain Cancer
EPFL scientists have found that combining antidepressants with anticoagulants slows down brain tumors (gliomas) in mice.
Old Drug Performs New Tricks
Cambridge-led research reveals the powers of a "wonder drug" that has lain under the noses of doctors for 50 years.
Electronic Reminders Keep TB Patients on Track With Medication In China
Giving electronic reminders to tuberculosis (TB) patients in China can reduce the amount of medication doses they miss by half, according to new research.
Common Drug Presents Fracture Risk To Older Women
Researchers are urging caution in prescribing one of the world’s most commonly issued drug groups, citing links to increased fracture risks in older Australian women.
Combining Epigenetic Therapies and Immunotherapies Improves Cancer Outcomes
Recent data suggest that epigenetic therapies are likely to provide additional clinical benefit to cancer patients when rationally combined with immunotherapeutic drugs.
LiMAx Test Shows Reversibility of Fatty Liver Disease After Obesity Surgery
Clinical study provides evidence for functional liver recovery after weight loss.
Landmark NIH Study Shows Intensive Blood Pressure Management May Save Lives
Lower blood pressure target greatly reduces cardiovascular complications and deaths in older adults.
Scroll Up
Scroll Down

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
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos