PRESS RELEASE May 23rd, 2010: Indianapolis, IN – General BioTechnology, a provider of safe, cost effective and quality driven stem cell manufacture, cryopreservation and banking methods is proud to be officially launching the ground breaking new technology, CellSeal(TM) cryogenic storage containers and accessories, at the International Society for Cellular Therapy (ISCT) 2010 show, in Philadelphia, PA, May 23rd – 26th. CellSeal(TM) is a patent-pending technology that provides the first cryogenic storage vials of their kind. CellSealTM allows for a completely sealed system that can be submerged under liquid nitrogen, while keeping aseptic retrieval post-thaw simple, safe and efficient. CellSeal(TM) Cryogenic Vials are the only completely closed devices of their kind available, and are made from state of the art materials under rigorous quality control.

Some of the benefits of this new technology include:

• Biocompatibility: vials are constructed with stable, USP Class VI materials (resistant to DMSO), sterilized via gamma irradiation and endotoxin tested.
• Quality: vials are manufactured under cGMP, with every unit produced subjected to a vacuum test among other quality measures to ensure ultimate protection of samples.
• Safety: vials are safe even in extreme conditions such as total submersion in liquid nitrogen, with no risk of explosion upon thawing when used correctly.
• Accessibility: CellSeal(TM) vials have a unique patent-pending design enabling easy loading of samples via inlet tubing which also allows for integral testsegments. Retrieval is simple and efficient as well via a sterile septum.

“With the emergence of clinical cellular therapies there came the need for more ideal systems to store cells in an efficient, closed, ready to use format. Especially with respect to smaller volumes of 1-5cc, such a system has not been available until now.” said Erik J. Woods, Ph.D., president and chief executive officer of General BioTechnology. “We were pleased to take on development and testing of the CellSealTM line of products, and see this as a continuation of our company’s goal of meeting unmet critical needs in cellular therapy.”

CellSeal(TM) solves several issues for safe sample storage. The system was built to meet the demands of today’s transfusion medicine and cell therapy industry. As regulatory and accrediting bodies continue to focus on safety and good tissue practice (GTP) issues, the need for CellSeal(TM) and their product suites will continue to grow.

All CellSeal(TM) products are manufactured with quality as the priority. CellSeal(TM), both directly and through partnerships with contract manufacturers, employs an integrated system approach to quality management. Our quality activities are not limited to inspection and test. Quality is considered at the earliest stages of design, product transfer and throughout the product life-cycle.

Since 1997, General BioTechnology has provided safe, cost effective and quality driven manufacture, cryopreservation and banking methods for diverse cell and tissue types enabling personalized reproductive lives, therapy and medicine. To get more information on CellSeal(TM) please call: 800-265-0945 or email: info@cellseal.com

ABOUT General BioTechnology LLC (GBT)
GBT was founded in 1997 by former Indiana University School of Medicine researchers. The company was initially based on novel technologies including methods and devices specifically related to giving biological cells and tissues shelf life through cryopreservation and tissue engineering. General BioTechnology LLC has been awarded SBIR grants to improve the culture, expansion, cryopreservation and banking of such diverse cell and tissue types as human pancreatic islets of Langerhans, blood platelets, umbilical cord blood, peripheral blood stem cells and spermatozoa. The company has also won contracts with several other biotechnology companies as well as various universities to aid in development of cryopreservation, banking and logistical procedures for “fragile” unique cell and tissue types. Research sponsored by these programs has resulted in the development of several patents directly assigned to GBT and several others licensed back related to various levels of processing. Presently, GBT runs a GMP stem cell manufacturing program along with an AABB accredited commercial cord blood bank (The Genesis Bank) and an anonymous donor and autologous sperm bank (Genome Resources), and works closely with several other start-up biotechnology or medical device companies, including VialCo LLC, the original developer of the CellSealTM technology.

But by the time she was 9 months old, Chloe was not reaching the milestones her older sister Shayla had met at that age. The Levines remembered they had banked stem cells from Chloe’s umbilical cord at her birth, and wondered if they could be used to help treat her.

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General BioTechnology will use a $350,000 grant from the state to further develop and test its Advanced CryoTechnology Cell Washing Device. The Indiana grant accompanies federal funding of more than $1 million to develop the device for clinical use.  The company plans to begin a pilot safety study of the technology in the first quarter of 2010 with Indiana University before a larger clinical trial later in the year continuing with the Fred Hutchison Cancer Research Center in Seattle, Wash., and Indiana University.

“We must continue to support companies like General BioTechnology that are leading the charge to increase the safety and comfort of medical procedures,” said Mitch Roob, Secretary of Commerce and chief executive officer of the Indiana Economic Development Corporation. “We know that high-technology companies like this will create the jobs of tomorrow, but more importantly, they have the potential to improve the quality of life for people across the world.”

General BioTechnology’s device, which is similar in size to a microwave oven, pumps bone marrow stem cells through a specially designed tube. The fiber filled tube gradually filters the Dimethyl Sulfoxide preservative from the bone marrow transplant while still maintaining the cell’s efficacy. DMSO is a commonly used preservative which increases the shelf life of cells, but can cause complications with patients when it is injected into their system.

“There has been a demand for this technology as long as frozen bone marrow transplants have been used to treat patients.  This project originated through our company’s mission of listening to physicians and specifically developing technologies to meet critical needs,” said Erik J. Woods, Ph.D., president and chief executive officer of General BioTechnology. “Over 30,000 people a year in this country receive this type of procedure, our hope is that our system will help yield better outcomes with fewer complications.”

Beyond this initial trial for bone marrow, ongoing research involves using the cell washing device to more effectively remove glycerol from standard frozen blood, making it more accessible to a wider pool of patients.  According to the National Heart, Lung and Blood Institute, there are currently more than 5 million blood transfusions performed in this country per year, mostly using fresh blood which spoils in about  one month using standard storage techniques. Woods estimates that General BioTechnology’s device could allow medical personnel to administer frozen blood in as little as 30 minutes. It’s a process he says normally takes up to three or four hours. 

Woods anticipates commercializing the device to the bone marrow stem cell transplant markets in late 2010 before fully launching the product to blood centers throughout North America in 2011. Indianapolis-based Medivative Technologies will manufacture the cell washing technology.

“The Medivative team is pleased to assist another Indiana company in the development and manufacture of an innovative medical device,” said Bryan Bowman, Medivative’s president.  “General BioTechnology’s Cell Washing Device will improve the quality of life for people recovering from cancer.”

Founded in 1997 General BioTechnology has, to date, focused on umbilical cord blood stem cell research and sperm banking. Research on the cell washing technology began in 2000.  The company has also launched the first cell manufacturing facility of its kind in the state, manufacturing cell therapy products for clinical trials to be performed at Indiana University. The company currently operates out of the Harlan Biotechnology Center near the IUPUI campus.

General BioTechnology is one of more than 120 companies that the Indiana Economic Development Corporation has assisted in securing funding from the federal government’s Small Business Innovation Research and Small Business Technology Transfer program. The SBIR/STTR is an effort by 11 federal agencies to accelerate the development of high-tech products for use by the government and consumers around the globe. The agency’s efforts to boost federal funding for Indiana business have resulted in a more than 62 percent increase in federal dollars to Indiana entrepreneurial businesses.

About General BioTechnology
General BioTechnology LLC (GBT) was founded in 1997 by former Indiana University School of Medicine researchers. The company was initially based on novel technologies including methods and devices specifically related to giving biological cells and tissues shelf life. General BioTechnology has been awarded several federal grants to improve the cryopreservation and banking methods of diverse cell and tissue types including human pancreatic islets of Langerhans, blood platelets, umbilical cord blood, peripheral blood stem cells and spermatozoa. For more information visit  www.gnrlbiotech.com 

About IEDC
Created by Governor Mitch Daniels in 2005 to replace the former Department of Commerce, the Indiana Economic Development Corporation is governed by a 12-member board chaired by Governor Daniels. Indiana Secretary of Commerce Mitch Roob serves as the chief executive officer of the IEDC.  For more information about IEDC, visit www.iedc.in.gov.

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