 |
| |||||
| |||||||
Low-cost, rapid production of proteins Correctly folded and biologically active cGMP-qualified master virus banks and cell line Extensive clinical use and regulatory history Scalable to large volumes and high cell densities FDA-qualified cell line and baculoviruses cGMP clinical materials at an affordable price
Applications
Our BEVS platform has been successfully used for the development of a wide range of vaccines and therapeutics:
Prophylactic vaccines - for the prevention of infectious diseases
expresSF+ Cells
We have created and patented a unique Spodoptera frugiperda insect cell line, expresSF+ cells, to optimize protein production using our BEVS technology. These cells have been extensively characterized and products manufactured from them have received regulatory clearance for human clinical testing in the United States, Japan, Australia, Europe, Canada and elsewhere. A veterinary PCV-2 vaccine produced in our cells is being marketed worldwide, including in the United States, Europe and Japan.
FDA-qualified
Serum-free, low cost growth media
High density growth and gene expression capability
Produces high titer AcNPV (108 PFU/ml)
Infected with low MOI
Stable for > 50 passages
18-24 hour doubling time
Do not clump or aggregate
Scalable for cGMP manufacturing
Serum-free:
expresSF+ cells do not require serum for growth or storage, and double about every 24 hours in our proprietary serum-free media. Unlike other serum-free insect cells, expresSF+ cells generate high titers of baculovirus. Therefore, a single cell line can be used for production of large quantities of protein.
High density:
expresSF+ cells can be grown to a density of 108 cells/ml. At a density of 107 cells/ml, the cells are nearly 100% viable in standard suspension cultures. We have established and patented high density fermentation and fed-batch procedures to maximize protein yield. Under these conditions, cell growth is exponential from 1.5X106 to more than 70X106 cells/ml in serum-free media, and viability remains at least 98%.
Licensing agreements are available to use our expresSF+ cells. Please contact Daniel Adams, Executive Chairman and Global Head of Business Development, at 1-203-686-0800 x303.
BioArctic Neuroscience is dedicated to providing novel treatments to help patients with central nervous system disorders. We manufactured recombinant fibroblast growth factor (FGF1) for BioArctic that is inserted into a biodegradable device intended for the surgical treatment of complete spinal cord injury. A study reporting the promise of this device has been published in the Journal of Biomaterials Applications.
Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, awarded us a contract in June 2009 to support further development and scale-up of our flu vaccines, Flublok and Panblok, including additional clinical studies required to secure approval for use in pediatrics and other populations not included in the initial FDA approval (contract number HHS0100200900106C). The contract has a budget of approximately $147 million over five years, with a base period (the first 18 months of the contract) budget of $34.5 million. In addition, the contract provides for an option to purchase Panblok vaccine at the discretion of the government.
In May 2011, BARDA formally exercised its option to extend our contract for an additional two-year period with a budget of approximately $47 million, and the Agency
subsequently extended its commitment to fund our influenza vaccine program including
refurbishment, scale-up and process improvement activities at our new Pearl River manufacturing facility through the end of 2013 with an additional budget of $15 million.
When this option ends, approximately $51 million will remain in the budget for the second option period.
Boehringer Ingelheim Vetmedica has a wide range of products for the treatment of animals and has licensed our expresSF+ cells for the production of a vaccine against porcine circovirus that is marketed worldwide (including the United States, Europe and Japan), as well as against certain other animal diseases.
Diamyd Medical AB Diamyd is a biopharmaceutical company in the fields of pain and diabetes. We assisted Diamyd in the development and manufacture of its therapeutic type 1 diabetes vaccine, Diamyd®, which progressed through Phase III clinical development.
Japan Tobacco, a Fortune 500 company, has a research license for our expresSF+ cells and related technology.
Merck, through a subsidiary, has licensed our expresSF+ cells and related technology to conduct vaccine research and for the commercial production of an undisclosed vaccine candidate.
The MetroHartford Alliance is the leading business and economic development organization in the Hartford region. In 2012, the Alliance founded the Connecticut Health Council, an association of health sector leaders who work together to promote Connecticut as a premier center for the development of businesses, initiatives and technology that improve healthcare and wellness both nationally and in the State. We are a Strategic Partner of the MetroHartford Alliance and a Founding Partner of the Connecticut Health Council.
Oxford Expression Technologies (OET) is a center of expertise for recombinant protein production using the baculovirus expression vector system (BEVS). We have worked with OET on the analysis and qualification of our expresSF+ cell line.
UMN Pharma Unmet Medical Needs (UMN) Pharma is a pharmaceutical company dedicated to developing innovative pharmaceutical products that will satisfy unmet medical needs. UMN has exclusively licensed Flublok and Panblok for the territories of Japan, China, Korea, Hong Kong, Taiwan and Singapore. UMN recently concluded a development and marketing partnership with Astellas Pharmaceuticals, a leading Japanese pharmaceutical company, and is actively conducting clinical trials and constructing two manufacturing facilities in Japan in partnership with IHI Corporation to support commercialization of the vaccine candidates.
uniQure, a leader in the field of human gene therapy, has licensed our BEVS technology to commercialize therapies for severe, orphan diseases. Our BEVS technology is a component of uniQure's validated, world-leading manufacturing platform.
Wako Corporation of Japan is our partner to distribute BEVS-generated research antigens and provide GeneXpress services to the Japanese marketplace.
|
|
