Life-Science Panorama

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April 30th, 2007

What Do Bioreactors and Thanksgiving Have in Common?

By Daniel R. Matlis

Thanksgiving dinner at my house involves all the staples and then some. Our turkey is moist and cooked to perfection, and clean up is a cinch since we began using Reynolds® Oven Bags.  You simply put the turkey in the heat-resistant nylon bag along with your favorite stuffing, vegetables, sauce or spices, place it in a baking pan and pop it in the oven. The Turkey comes out juicy and delicious with no messy pan to scrub.

I know what you are thinking, Dan you are breaking your rule about keeping Life-Science Panorama articles focused on Life-Science Issues. 

Au contraire mon freire or soeur.

Last week, at Interphex, I learned that plastic bags make for great cell culturing and no messy tank to clean, scrub or steam. (You have to see this)
 
At the show, I had the opportunity to chat with Dr. Vijay Singh, founder of Wave Biotech (now Part of GE Healthcare). He explained that Wave develops and manufactures innovative process equipment for the pharmaceutical and biotechnology industry. Their focus is disposable bioprocess equipment for operations.

Traditional cell culture is performed in stainless steel stirred tanks. The issue is that stirring can destroy cells due to fluid shear. Aeration is done by bubbling—which could be detrimental to product yields. Finally, empty tanks must be cleaned and sterilized, before they can be used again.

Albert Einstein said: “Things should be made as simple as possible, but not any simpler.”

I think Einstein would be very pleased if he saw the Wave Bioreactor®.

The concept is elegantly simple. The Wave Bioreactor employs pre-sterilized plastic bags - called Cellbags® - as single-use, disposable bioreactors. This design eliminates the need for cleaning, sterilization, and associated validation. The gamma-radiation sterilized Cellbags reduce the risk of contamination due to equipment malfunction or operator error typical of traditional bioreactors such as stirred tanks, spinners, and hollow-fiber systems.

Wave’s recent innovations included the development of bags with internal filters for perfusion and the scale up to culture with volumes up to 500 liters. Wave technology spin-offs include Wave Mixers which provide non-invasive sterile mixing, Wave Warmers for thawing applications, and a host of instrumentation suitable for introduction into bags.

The use of disposable contact materials eliminates cleaning and validation, thereby reducing costs in operations ranging from cell culture, media preparation, buffer dissolution, thawing process intermediates to patient-specific cell therapy in hospitals.

According to Dr. Singh “these unique, patented, devices can be installed and commissioned rapidly, drastically reducing the time-to-market for biological products. Our equipment is in use with hundreds of companies worldwide, both for R&D, as well as commercial applications.”

So next time you need to feed 15 for dinner or culture cells for personalized therapies, reach for a plastic bag, and save yourself the hassle of cleaning.

April 11th, 2007

Axendia to Present at World’s Largest Pharmaceutical Conference

The Session Will Address Business and Technology Enablers to Bridge Information Gap

FOR IMMEDIATE RELEASE
CONTACT: Monica Malave
Director, Marketing & Communications
mmalave@axendia.com

Yardley, PA, April 11, 2007- Axendia, a trusted advisor to Life-Science Executives on Business, Technology and Regulatory strategies, today announced that its President and Founder, Daniel R. Matlis, will provide an address at INTERPHEX2007, the world’s largest and most comprehensive pharmaceutical conference.

Life-Science companies have been stockpiling raw data in various computers for more than 30 years. This has lead to a condition know as Data Rich, Information Poor (DRIP).  To address DRIP, organizations must interpret this raw data and move up the knowledge value chain to produce information, knowledge, wisdom and ultimately truth.

“Life-Science Executives yearn for the ability to transform raw data into knowledge to enable a more informed and timely decisions making process.” said Daniel R. Matlis, President and Founder of Axendia.  “Today’s Information Technology based on a Service Oriented Architecture provides a foundation for bridging the knowledge gap” he added.

The session will be held on Wednesday, April 25, 2007 at 9:00 AM, at the INTERPHEX2007 conference at the Jacob K. Javits Convention Center in New York City. For detailed information about this session, visit: http://interphex.conferencepath.com/speakerlist/?action=showsessions&userid=16329

About Axendia
Axendia is the leading analysis firm focused strictly on the Life-Sciences and Healthcare markets. Our Mission is to be the most trusted advisor to Life-Science Executives on Business, Regulatory and Technology issues. With over 16 years experience in the Life-Sciences and Healthcare industries, Axendia provides a unique combination of hands on experience coupled with strategic vision. This enables us to successfully identify, create and execute strategies which provide lasting business value for our clients. Additional information on Axendia’s can be found at www.Axendia.com

About the Interphex2007
INTERPHEX2007 is the world’s largest and most comprehensive pharmaceutical conference and exhibition.  It is presented by Reed Exhibitions and sponsored by ISPE, the international society for pharmaceutical engineering, and Pharmaceutical Processing magazine.  The application-oriented INTERPHEX2007 conference program will offer over 100 separate educational sessions to help pharmaceutical and biotech professionals develop critical skills to increase on-the-job performance.  Approximately 1000 leading global companies serving pharmaceutical and biotechnical industries will showcase the latest lines of equipment, technologies and services. Additional information on INTERPHEX2007 can be found at www.interphex.com

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