VAI, Inc, BIODESIGN International’s biopharmaceutical facility, has been awarded a contract to manufacture clinical grade recombinant Parvovirus B19 vaccine for The National Institutes of Health. Vaccine production will take place at the company’s cGMP life science manufacturing facility located in Memphis. VAI will manufacture Parvovirus B19 vaccine for Phase I human clinical trials to be conducted by the National Heart, Lung, and Blood Institute (NHLBI). Upon successful completion of the Phase I clinicals, the NHLBI has an option to continue the manufacture of additional vaccine for Phase II human clinical trials from VAI.
The NIH/NHLBI have a long-standing interest in Parvovirus B19, an important pathogen affecting humans. Parvovirus B19 infection is common among children and adults and is often asymptomatic. Parvovirus B19 infection can result in serious and occasionally fatal hematologic diseases in susceptible patients, and is the cause of "fifth disease", a highly contagious infection of childhood. In sickle cell disease and other hereditary and acquired hemolytic anemias, acute B19 infection results in transient a plastic crisis, in which hemoglobin levels precipitously fall, anemia becomes life threatening, and congestive heart failure may ensue. Parvovirus B19 can also infect the fetus causing severe anemia, congestive heart failure, and heath in utero or at birth.
Many of the clinical manifestations of Parvovirus B19 infection in humans were discovered by NHLBI scientists. As a result of this research, a method to express Parvovirus B19 structural proteins and recombinant B19 virus-like particles was developed and patented by the federal government. VAI will utilize these patented protein expression methods to supply sufficient clinical grade B19 recombinant parvovirus capsids for use as a vaccine in Phase I and Phase II clinical trials to be conducted by NIH. VAI will also be responsible for regulatory requirements including maintenance or renewal of the current Investigational New Drug Application (IND) with the U.S. Department of Health and Human Services Food and Drug Administration (FDA) for recombinant B19 parvovirus capsids.
Viral Antigens, Inc. has been a leading supplier of cell culture produced viral antigens for the past 20 years. These antigens are used as components in infectious disease test kits manufactured by medical diagnostic companies throughout the world.
VAI’s facility and support areas are staffed with personnel experienced in cell culture, purification and regulatory affairs. Processes, equipment and test procedures can be rapidly adjusted to fit each client’s individual needs.
Our capabilities include:
- Production of recombinant proteins and antibodies in cultures up to 100 Liters
- Protein purification by conventional and specialized techniques
- Cloning strategy and expression system development for high level production of active, functional proteins
- Media optimization for production in mammalian, insect and bacterial cells
- Development of protein purification procedures
VAI is ready to handle your diverse needs whether you are a:
- Startup/Virtual Pharmaceutical Company
- Emerging Pharmaceutical Company
- Experienced Pharmaceutical Company
- Diagnostic Company requiring cGMP production
- Veterinary Vaccine Company
- Research Institute
Viral Antigens, Inc. is a subsidiary of Meridian Bioscience, Inc., Cincinnati, Ohio. Meridian is a fully integrated life sciences company that manufacturers, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. The company markets its products to hospitals, reference laboratories, research centers, veterinary testing centers and physician offices in more than 60 countries around the world.
For more information contact:
Viral Antigens, Inc.
5171 Wilfong Road
Memphis, TN 38134 USA
Tel: 901-382-8716
Fax: 901-382-0027
www.viralantigens.com
Email: vai@viralantigens.com
Viral Antigens, Inc. (VAI) and BIODESIGN International are sister companies. |