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News Article -- April 20, 2009
Cambridge Biostability Ltd in Collaboration with DVC Produces Shelf Stable Pentavalent Botulinum Vaccine
Cambridge Biostability announces results of third milestone of its collaboration with DynPort Vaccine Company LLC
Cambridge Biostability Ltd (CBL) and DynPort Vaccine Company LLC (DVC), a CSC (NYSE: CSC) company, have successfully produced a thermally stable, rapidly injectable, pentavalent recombinant botulinum vaccine candidate. Preliminary efficacy studies in mice showed that after storage at 55 degrees Celsius for six months, this stabilised vaccine candidate provided protection against lethal challenge with each of five botulinum neurotoxin serotypes. In contrast, a non-stabilised preparation of the vaccine formulation stored under the same conditions for one month lost the capacity to protect mice.
The key to this enhanced stability is CBL's VitRIS technology, in which excipients are combined with the vaccine candidate and the mixture is spray dried to form glass microspheres. Once the labile vaccine is embedded in the microspheres, the vaccine becomes stable without the need of refrigeration. The microspheres are then suspneded in an inert, anhydrous liquid to produce a smooth, instantly injectable suspension. By mixing microspheres containing different antigens in the inert liquid, many vaccines can potentially be combined in a single dose.
The stable, instantly injectable, pentavalent recombinant botulinum vaccine confirms the value of CBL's VitRIS technology, and provides proof of concept that an effective technology for establishing biodefence stockpiles without the need for refrigeration is indeed feasible.
The thermally stable pentavalent recombinant botulinum vaccine candidate is designed to provide protection against exposure to botulinum neurotoxin serotypes A, B, C, E and F. Botulinum neurotoxins are Category A select agents with the potential to produce widespread harm if used in a bioterrorist attack. Each botulinum neurotoxin serotype is extremely potent and long-lasting, with the potential to produce high rates of morbidity and mortality. The development of an effective and thermally stable botulinum neurotoxin vaccine is a key component of a comprehensive biodefence strategy.
CBL is a major collaborator in a $5.4 million grant awarded to DVC in 2004 by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (Grant Number 1 UC1 AI062531-01). Some vaccine antigens and related data used in the achievement of the current milestone were provided by the U.S. Department of Defense through the Chemical Biological Medical Systems-Joint Vaccine Acquisition Program (CBMS-JVAP). All of these antigen products were originally identified and developed by scientists working at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). Their work involved the identification of suitable protein antigens and the development of the processes used to assess the performance of the vaccine.
The safety and efficacy of this product in humans has not been established. The product is currently under development and has not been licensed by the FDA.
About CBL
Cambridge Biostability Ltd is a technology company which has developed unique technologies and expertise for the formulation of a wide range of pharmaceuticals and biological products in thermo-stable, instantly injectable formats. CBL's technology is based on two main platforms - VitRIS and HydRIS - which use glass-forming excipients to enable the development and production of "user-friendly" pharmaceuticals. To learn more about CBL please visit our website at www.biostability.com.
About DVC
DynPort Vaccine Company LLC (DVC) manages product development programs and provides consulting, technical and program management services to U.S. government agencies and companies in the biotechnology and pharmaceutical industries. For more information, visit www.csc.com/dvc. DVC is part of CSC's North American Public Sector business unit's Government Health Services Division. CSC's expertise in providing health services to government agencies has grown over the last five decades to offer commercial best practices integrated to meet federal, state and local healthcare requirements. Services range from optimizing claims processing to operating disease surveillance systems to vaccine development and management. CSC's ideas and solutions are improving the quality of healthcare with better information for better decisions to save lives and money.
About CSC
CSC is a global leader in providing technology-enabled solutions and services through three primary lines of business. These include Business Solutions & Services, Global Outsourcing Services and the North American Public Sector. CSC's advanced capabilities include systems design and integration, information technology and business process outsourcing, applications software development, Web and application hosting, mission support and management consulting. Headquartered in Falls Church, Va., CSC has approximately 92,000 employees and reported revenue of $17.1 billion for the 12 months ended Jan. 2, 2009. For more information, visit the company's website at www.csc.com.
This project has been funded in whole or in part whith Federal (United States Government) funds from the National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID) , under grant number 1 UC1 AI062531-01. Pursuant to Section 507 of P.L. 104-208 and Section 508 of P.L. 105-78, 100% of the total of this project's costs are financed with Federal funds. The content of this publication does not necessarily reflect the views or polices of the United States Department of Health and Human Services, nor does metion of trade names, commercial products, or organizations imply endorsement by the U.S. Government.
