This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

FDA Clears Life Technologies' OpTmizer™ T-Cell Growth Medium For Use In Clinical Trials

CARLSBAD, Calif., Sept. 27, 2012 /PRNewswire/ --  Life Technologies Corporation (NASDAQ: LIFE) today announced 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. "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.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 17,798.49 -14.90 -0.08%
S&P 500 2,090.11 +1.24 0.06%
NASDAQ 5,127.5250 +11.3820 0.22%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs