JN-International Medical Corporation
Encyclopedia
JN-International Medical Corporation 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. JN-International Medical Corporation (JNIMC) has overseas business offices and clinical trial centers located in Abidjan, Ivory Coast in Africa and in Kuala Lumpur, Malaysia, with vaccine cold chain facilities in Burkina Faso and Singapore. JNI partners with Global Health Organizations such as the Clinton Global Initiative,,the Global Business Coalition, New York President's Malaria Initiative and PEPFAR. JNI also partners with several other non-profit global health organizations, NGOs, local governments and communities in developing countries to address the health issues related to HIV AIDS Malaria
Tuberculosis
and Bacterial Meningitis
that scourges the underserved communities in West Africa, South East Asia and Latin America.
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. Early in 2003 the U.S. invented diagnostic technology was acquired by China and India. Within one Year the U.S. production costs became too high to effectively market U.S. made diagnostics so JNI began concentrating on its vaccine division.
Meningococcal meningitis disease, also referred to as cerebrospinal meningitis is a contagious bacterial disease caused by Neisseria meningitidis
bacteria. Meningococcal infections occur worldwide and are the only bacterial agents associated with epidemic meningitis in the meningitis belt of sub-Saharan Africa. With the culmination of several years of research, JN-International developed its vaccine for Meningococcal meningitis serogroups A, C, Y and W-135 (NmVac4-A/C/Y/W-135). The efficacy of the vaccine was tested in sub-Saharan Africa (Niger and Burkina Faso) using 750 people for a period of 56 months. Protective sero-conversion successfully occurred and was tested and recorded in vaccinated individuals during a spontaneous disease outbreak. However, it is well known that this type of vaccine gives disease protection for no more than 18 months. To better serve the market the company worked on and developed a Meningococcal meningitis serogroups A, C, Y and W-135 Diphtheria toxoid conjugate vaccine (NmVac4-A/C/Y/W-135 - DT), by using a genetically detoxified Diphtheria Toxoid as the protein carrier. This method has been shown to provide a minimum of 3 years protection. JNI’s conjugate meningococcal vaccine was tested in the Ivory Coast using 100 sero-negative male and female children and adults. Protective sero-conversion was recorded in 98% of the individuals as tested and recorded by the Pasteur Institute
Côte d'Ivoire. JN-International is presently working to produce these vaccines in the United States. Production with regulatory approval for U.S. export is in process and will probably take a few years.
The research and development division of JN-International is in various stages for the development of vaccines for the prevention and cure of Hepatitis C
Herpes Tuberculosis
and a preventive and therapeutic vaccine for stroke.
Inc in Omaha. The state-of-the-art facilities consist of three buildings approximately 80,000 sq. ft., and were designed for manufacture of vaccines in compliance with European Community, U.S. Food and Drug Administration and U.S. Department of Agriculture standards. JN-International shall keep the Starwood containment facility for research and development of vaccines for clinical studies and moves its vaccine operations to the newly acquired Maple street facilities in February 2009. The added capacity of the plant will allow 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.
The following is a list of key Diagnostic products. The names shown are all registered trademarks of JN International.
Malaria
Malaria is a mosquito-borne infectious disease of humans and other animals caused by eukaryotic protists of the genus Plasmodium. The disease results from the multiplication of Plasmodium parasites within red blood cells, causing symptoms that typically include fever and headache, in severe cases...
Tuberculosis
Tuberculosis
Tuberculosis, MTB, or TB is a common, and in many cases lethal, infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis. Tuberculosis usually attacks the lungs but can also affect other parts of the body...
and Bacterial Meningitis
Bacterial meningitis
Bacterial meningitis refers to meningitis that is caused by bacterial infection.-Signs and Symptoms:*Fever*Seizures*Meningismus*Headache*Vomiting*Photophobia*Altered mental status and coma*Anorexia...
that scourges 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. 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 tuberculosisMycobacterium tuberculosis
Mycobacterium tuberculosis is a pathogenic bacterial species in the genus Mycobacterium and the causative agent of most cases of tuberculosis . First discovered in 1882 by Robert Koch, M...
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. Early in 2003 the U.S. invented diagnostic technology was acquired by China and India. Within one Year the U.S. production costs became too high to effectively market U.S. made diagnostics so JNI began concentrating on its vaccine division.
Vaccine development
Neisseria meningitidis
Neisseria meningitidis, often referred to as meningococcus, is a bacterium that can cause meningitis and other forms of meningococcal disease such as meningococcemia, a life threatening sepsis. N. meningitidis is a major cause of morbidity and mortality during childhood in industrialized countries...
bacteria. Meningococcal infections occur worldwide and are the only bacterial agents associated with epidemic meningitis in the meningitis belt of sub-Saharan Africa. With the culmination of several years of research, JN-International developed its vaccine for Meningococcal meningitis serogroups A, C, Y and W-135 (NmVac4-A/C/Y/W-135). The efficacy of the vaccine was tested in sub-Saharan Africa (Niger and Burkina Faso) using 750 people for a period of 56 months. Protective sero-conversion successfully occurred and was tested and recorded in vaccinated individuals during a spontaneous disease outbreak. However, it is well known that this type of vaccine gives disease protection for no more than 18 months. To better serve the market the company worked on and developed a Meningococcal meningitis serogroups A, C, Y and W-135 Diphtheria toxoid conjugate vaccine (NmVac4-A/C/Y/W-135 - DT), by using a genetically detoxified Diphtheria Toxoid as the protein carrier. This method has been shown to provide a minimum of 3 years protection. JNI’s conjugate meningococcal vaccine was tested in the Ivory Coast using 100 sero-negative male and female children and adults. Protective sero-conversion was recorded in 98% of the individuals as tested and recorded by the Pasteur Institute
Pasteur Institute
The Pasteur Institute is a French non-profit private foundation dedicated to the study of biology, micro-organisms, diseases, and vaccines. It is named after Louis Pasteur, who made some of the greatest breakthroughs in modern medicine at the time, including pasteurization and vaccines for anthrax...
Côte d'Ivoire. JN-International is presently working to produce these vaccines in the United States. Production with regulatory approval for U.S. export is in process and will probably take a few years.
The research and development division of JN-International is in various stages for the development of vaccines for the prevention and cure of Hepatitis C
Hepatitis C
Hepatitis C is an infectious disease primarily affecting the liver, caused by the hepatitis C virus . The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years...
Herpes Tuberculosis
Tuberculosis
Tuberculosis, MTB, or TB is a common, and in many cases lethal, infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis. Tuberculosis usually attacks the lungs but can also affect other parts of the body...
and a preventive and therapeutic vaccine for stroke.
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 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 systems (ICS). JNIMC's cGMP vaccine facility spans 82,000ft² and will include a 20,000ft² fully automated unit. The facility has a targeted production of 60 million doses of vaccine annually.Acquisition
In January 2009, JNIMC acquires Biocor vaccine manufacture facilities, a subsidiary of PfizerPfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
Inc in Omaha. The state-of-the-art facilities consist of three buildings approximately 80,000 sq. ft., and were designed for manufacture of vaccines in compliance with European Community, U.S. Food and Drug Administration and U.S. Department of Agriculture standards. JN-International shall keep the Starwood containment facility for research and development of vaccines for clinical studies and moves its vaccine operations to the newly acquired Maple street facilities in February 2009. The added capacity of the plant will allow 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.
Products
The following is a list of key Vaccine products. The names shown are all registered trademarks of JN International.- NmVac4-A/C/Y/W-135NmVac4-A/C/Y/W-135NmVac4-A/C/Y/W-135 is the commercial name of the Meningococcal meningitis polysaccharide serogroups A,C,Y and W-135 vaccine of JN-International Medical Corporation...
Meningococcal meningitis vaccine for prevention of Meningococcal meningitis serogroups A, C, Y and W-135 disease. - NmVac4-A/C/Y/W-135 - DTNmVac4-A/C/Y/W-135 - DTNmVac4-A/C/Y/W-135-DT is the commercial name of the Meningococcal meningitis polysaccharide serogroups A.C.Y.W-135 Diphtheria conjugate vaccine of JN-International Medical Corporation. The product is designed and formulated to protect populations during Meningitis disease epidemics in developing...
Meningococcal meningitis diphtheria conjugate vaccine for prevention of Meningococcal meningitis serotypes A, C, Y and W-135. - In human clinical trials in California with IND approval from FDA. and
The following is a list of key Diagnostic products. The names shown are all registered trademarks of JN International.
- JN-QC-Spot HIV-1/2 for rapid diagnosis of HIV types 1 & 2
- JN-QC-Spot TB for rapid diagnosis of Tuberculosis
- JN Malaria pLDH for rapid diagnosis of Malaria latate dehydrogenase (LDH) in human blood as an aid in the diagnosis of Malaria infection caused by Plasmodium falciparumPlasmodium falciparumPlasmodium falciparum is a protozoan parasite, one of the species of Plasmodium that cause malaria in humans. It is transmitted by the female Anopheles mosquito. Malaria caused by this species is the most dangerous form of malaria, with the highest rates of complications and mortality...
Plasmodium vivaxPlasmodium vivaxPlasmodium vivax is a protozoal parasite and a human pathogen. The most frequent and widely distributed cause of recurring malaria, P. vivax is one of the four species of malarial parasite that commonly infect humans. It is less virulent than Plasmodium falciparum, which is the deadliest of the...
Plasmodium malariaePlasmodium malariaePlasmodium malariae is a parasitic protozoa that causes malaria in humans. It is closely related to Plasmodium falciparum and Plasmodium vivax which are responsible for most malarial infection. While found worldwide, it is a so-called "benign malaria" and is not nearly as dangerous as that...
Plasmodium ovalePlasmodium ovalePlasmodium ovale is a species of parasitic protozoa that causes tertian malaria in humans. It is closely related to Plasmodium falciparum and Plasmodium vivax, which are responsible for most malaria. It is rare compared to these two parasites, and substantially less dangerous than P... - JN Malaria HRP2 for rapid diagnosis of Malaria Histidine-rich Protein 2 (HRP2) in human blood as an aid in the diagnosis of Malaria infection caused by Plasmodium falciparumPlasmodium falciparumPlasmodium falciparum is a protozoan parasite, one of the species of Plasmodium that cause malaria in humans. It is transmitted by the female Anopheles mosquito. Malaria caused by this species is the most dangerous form of malaria, with the highest rates of complications and mortality...
Vaccine Phase Action Stroke StrokeA stroke, previously known medically as a cerebrovascular accident , is the rapidly developing loss of brain function due to disturbance in the blood supply to the brain. This can be due to ischemia caused by blockage , or a hemorrhage...Non-IND Phase I clinical trial Clinical trialClinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...For prevention and Therapy for Transient Ischemic Attack (TIA), Epilepsy and Transient Ischemic Stroke. Hepatitis C Hepatitis CHepatitis C is an infectious disease primarily affecting the liver, caused by the hepatitis C virus . The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years...Pre-clinical development Pre-clinical developmentIn drug development, pre-clinical development is a stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and drug safety data is collected....For prevention for Hepatitis C genotype-1. Genital Herpes Pre-clinical development Pre-clinical developmentIn drug development, pre-clinical development is a stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and drug safety data is collected....For prevention of Genital Herpes. Tuberculosis TuberculosisTuberculosis, MTB, or TB is a common, and in many cases lethal, infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis. Tuberculosis usually attacks the lungs but can also affect other parts of the body...Pre-clinical development Pre-clinical developmentIn drug development, pre-clinical development is a stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and drug safety data is collected....For prevention of TB.