JN-International Medical Corporation (JNIMC) is a U.S.-based biopharmaceutical corporation which since 1998 has been focused on developing vaccines and diagnostics for infectious disease for developing countries. This private corporation (formerly known as Jeeri Neotech International, Inc) was founded in 1998 by Dr. Jeeri R. Reddy with the help of Dr. Kelly F. Lechtenberg in a small rural town, Oakland, Nebraska. From there it grew and expanded until in the year 2000 the corporation moved to Omaha, Nebraska.
JNIMC partners with Global Health Organizations such as the
Clinton Global Initiative
The Clinton Foundation (founded in 2001 as the William J. Clinton Presidential Foundation, and renamed in 2013 as the Bill, Hillary & Chelsea Clinton Foundation) is a nonprofit organization under section 501(c)(3) of the U.S. tax code. It was es ...
, the Global Business Coalition, New York,
President's Malaria Initiative
The President's Malaria Initiative (PMI) is a U.S. Government initiative to control and eliminate malaria, one of the leading global causes of premature death and disability. The initiative was originally launched by U.S. president George W. Bush ...
(PMI), The Global Health Council, NGOs, local governments and communities in developing countries to address the health issues related to
HIV AIDS
Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual ma ...
,
malaria
Malaria is a mosquito-borne infectious disease that affects humans and other animals. Malaria causes symptoms that typically include fever, tiredness, vomiting, and headaches. In severe cases, it can cause jaundice, seizures, coma, or death. S ...
,
tuberculosis
Tuberculosis (TB) is an infectious disease usually caused by '' Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can also affect other parts of the body. Most infections show no symptoms, in ...
, and
bacterial meningitis
Meningitis is acute or chronic inflammation of the protective membranes covering the brain and spinal cord, collectively called the meninges. The most common symptoms are fever, headache, and neck stiffness. Other symptoms include confusion or ...
that affect the underserved communities in West Africa, South East Asia, and Latin America.
History
Early in its existence JNIMC developed rapid and western blot diagnostic test kits for Malaria TB and HIV. JNI was the first company to screen about 2 million pregnant women for the presence of HIV in South East Asia from 1999 – 2002. This resulted in many HIV-free births because the hospitals were able to treat the HIV positive pregnant women with
Antiretroviral drugs
The management of HIV/AIDS normally includes the use of multiple antiretroviral drugs as a strategy to control HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life-cycle. The use of multipl ...
. A rapid Tuberculosis test was developed by the company and demonstrated its diagnostic potential by screening 400 TB positive and negative serum samples from various hospitals in India. The results showed that the combination of
Mycobacterium tuberculosis
''Mycobacterium tuberculosis'' (M. tb) is a species of pathogenic bacteria in the family Mycobacteriaceae and the causative agent of tuberculosis. First discovered in 1882 by Robert Koch, ''M. tuberculosis'' has an unusual, waxy coating on its c ...
antigens improved the diagnostic specificity and sensitivity of the tests.
The diagnostic products of the company have been used in more than 30 countries for screening infectious diseases.
Vaccine facilities
JNIMC facility was designed for manufacture, research and development of human vaccines in compliance with FDA compliant cGMP (Current Good Manufacturing Practices) and European Union Good Manufacturing Practice standards. The facility has fermentation, formulation, vial, freeze drying bacterial facilities classified as Biosafety Level 2 (CDC-NIH BL2-LS) and
ISO 9001
The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 90 ...
. The facility includes both the upstream and downstream operations when the fermentation process is scaled up for bacterial polysaccharide product development. The facilities were designed for manufacture of vaccines in compliance with cGMP and European standards. The facility has fermentation, formulations and lyophilization and handling of bacterial polysaccharide products. Utilities include Water-For-Injection Grade Water (WFI) system, oil-free compressed air system (USP), clean steam system, process chilled system and Clean-in-Place systems. Processes include; seed bank, media preparation, fermentation, cell harvest, centrifugation and purification including ultra filtration. The facility operates with SCADA (supervisory control and data acquisition) generally refers to
industrial control system
An industrial control system (ICS) is an electronic control system and associated instrumentation used for industrial process control. Control systems can range in size from a few modular panel-mounted controllers to large interconnected and in ...
s (ICS). JNIMC's cGMP vaccine facility spans 32,000 ft² and will include a 10,000 ft² fully automated unit. The facility has a targeted production of 10 million doses of vaccine annually.
Image:Jninternational7.jpg, cGMP vaccine facility.
Image:jninternational2.jpg, cGMP facility inside.
Image:jninternational3.jpg, 1000 liters Bioreactors.
Image:jninternational6.jpg, Vialing Station.
Acquisition and Bankruptcy
In January 2009, JNIMC acquired Biocor vaccine manufacture facilities, a subsidiary of
Pfizer
Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...
Inc. in Omaha. The facilities consist of three buildings approximately 71,749 sq. ft., and were designed for manufacture of vaccines in compliance with European Community,
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
and
U.S. Department of Agriculture
The United States Department of Agriculture (USDA) is the federal executive department responsible for developing and executing federal laws related to farming, forestry, rural economic development, and food. It aims to meet the needs of com ...
standards. JNIMC will keep the Starwood containment facility for research and development of vaccines for clinical studies and moved its vaccine operations to the newly acquired Maple street facilities in February 2009. The added capacity of the plant allowed increased production of the firm's meningitis vaccine. The investment in the new facility plant is the largest capital investment in Omaha to date for the company, and will result in production, formulation, filling and packaging capacity facilities, which are intended to help significantly reduce time to market for the firm's Meningococcal meningitis serotypes A, C, Y & W-135 vaccine production capacity to meet the demand of sub-Saharan Africa.
JN Medical Corporation of Omaha, NB has filed a Petition for Relief pursuant to Ch. 11 of the Bankruptcy Code in the United States Bankruptcy Court for the District of Nebraska, case no. 17-80174-TLS. This occurred due to lack of funds from the shareholders, through they supported the company until 2015.
Clinical Trials
Meningococcal meningitis diphtheria conjugate vaccine
*
NmVac4-A/C/Y/W-135 - DT
NmVac4-A/C/Y/W-135 is the commercial name of the polysaccharide vaccine against the bacterium (specifically serogroups A, C, Y, and W-135) that causes meningococcal meningitis. The product, by JN-International Medical Corporation, is designed and ...
Meningococcal meningitis diphtheria conjugate vaccine for the prevention of Meningococcal meningitis serogroups A, C, Y and W-135 Diphtheria conjugate vaccine. Phase-1 and 2 human clinical trials completed in California and Maryland with IND approval from Food and Drug Administration (FDA) and
National Institutes of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
.
Research and development
Patents and publications
JNIMC patents and publishes Journal articles of its research and technologies in the field of human infectious diseases and neurological disorders
[ Patents by Inventor Jeeri R Reddy]
References
External links
*
{{DEFAULTSORT:JN-International Medical Corporation.
Biotechnology companies of the United States
Companies based in Omaha, Nebraska
Multinational companies headquartered in the United States
Vaccine producers