JN-International Medical Corporation

Last updated
JN-International Medical Corporation
TypePrivate
IndustryBiopharmaceutical
Founded1998
Headquarters Flag of the United States.svg Omaha, Nebraska
Key people
Jeeri R. Reddy, Founder
ProductsVaccines, Diagnostics
Website http://www.jn-vaccines.com

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.

Contents

JNIMC partners with Global Health Organizations such as the Clinton Global Initiative, [1] the Global Business Coalition, New York, President's Malaria Initiative (PMI), [2] [3] The Global Health Council, NGOs, local governments and communities in developing countries to address the health issues related to HIV AIDS, malaria, tuberculosis, and bacterial meningitis 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 [4] 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 tuberculosis antigens improved the diagnostic specificity and sensitivity of the tests. [5] 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 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 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.

Acquisition and Bankruptcy

In January 2009, JNIMC acquired Biocor vaccine manufacture facilities, a subsidiary of Pfizer Inc. in Omaha. [6] 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 and U.S. Department of Agriculture 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, NE 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

Research and development

VaccinePhaseAction
Ischemic stroke Pre-clinical development For the prevention and Therapy for Transient Ischemic Attack (TIA), Epilepsy, and Transient Ischemic Stroke.
Genital herpes Pre-clinical development For the Prevention of Genital Herpes.
Alzheimer's disease Pre-clinical development For the Prevention and Therapy for Alzheimer's disease.

Patents and publications

JNIMC patents and publishes Journal articles of its research and technologies in the field of human infectious diseases and neurological disorders [5] [9] [10] [11] [12] [13] [14] Patents by Inventor Jeeri R Reddy [15]

Related Research Articles

ATC code J07Vaccines is a therapeutic subgroup of the Anatomical Therapeutic Chemical Classification System, a system of alphanumeric codes developed by the World Health Organization (WHO) for the classification of drugs and other medical products. Subgroup J07 is part of the anatomical group J Antiinfectives for systemic use.

<i>Haemophilus influenzae</i> Species of bacterium

Haemophilus influenzae is a Gram-negative, non-motile, coccobacillary, facultatively anaerobic, capnophilic pathogenic bacterium of the family Pasteurellaceae. The bacteria are mesophilic and grow best at temperatures between 35 and 37 °C.

<span class="mw-page-title-main">Conjugate vaccine</span> Type of vaccine

A conjugate vaccine is a type of subunit vaccine which combines a weak antigen with a strong antigen as a carrier so that the immune system has a stronger response to the weak antigen.

<i>Neisseria meningitidis</i> Species of bacterium that can cause meningitis

Neisseria meningitidis, often referred to as the meningococcus, is a Gram-negative bacterium that can cause meningitis and other forms of meningococcal disease such as meningococcemia, a life-threatening sepsis. The bacterium is referred to as a coccus because it is round, and more specifically a diplococcus because of its tendency to form pairs.

<span class="mw-page-title-main">Meningococcal disease</span> Medical condition

Meningococcal disease describes infections caused by the bacterium Neisseria meningitidis. It has a high mortality rate if untreated but is vaccine-preventable. While best known as a cause of meningitis, it can also result in sepsis, which is an even more damaging and dangerous condition. Meningitis and meningococcemia are major causes of illness, death, and disability in both developed and under-developed countries.

<span class="mw-page-title-main">Hib vaccine</span> Haemophilus influenzae type B vaccine

The Haemophilus influenzae type B vaccine, also known as Hib vaccine, is a vaccine used to prevent Haemophilus influenzae type b (Hib) infection. In countries that include it as a routine vaccine, rates of severe Hib infections have decreased more than 90%. It has therefore resulted in a decrease in the rate of meningitis, pneumonia, and epiglottitis.

John Bennett Robbins was a senior investigator at the National Institutes of Health (NIH), best known for his contribution to the development of the vaccine against bacterial meningitis Hib)) with his colleague Rachel Schneerson. He conducted research on the Bethesda, Maryland campus of the NIH from 1970 until his retirement at the age of 80 in 2012. During his tenure, he worked in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Food and Drug Administration’s biologics laboratories on location.

A pneumococcal infection is an infection caused by the bacterium Streptococcus pneumoniae, which is also called the pneumococcus. S. pneumoniae is a common member of the bacterial flora colonizing the nose and throat of 5–10% of healthy adults and 20–40% of healthy children. However, it is also a cause of significant disease, being a leading cause of pneumonia, bacterial meningitis, and sepsis. The World Health Organization estimates that in 2005 pneumococcal infections were responsible for the death of 1.6 million children worldwide.

NmVac4-A/C/Y/W-135 is the commercial name of the polysaccharide vaccine against the bacterium that causes meningococcal meningitis. The product, by JN-International Medical Corporation, is designed and formulated to be used in developing countries for protecting populations during meningitis disease epidemics.

<span class="mw-page-title-main">Jeeri R. Reddy</span>

Jeeri Reddy an American biologist who became an entrepreneur, developing new generation preventive and therapeutic vaccines. He has been an active leader in the field of the biopharmaceutical industry, commercializing diagnostics and vaccines through JN-International Medical Corporation. He is the scientific director and president of the corporation that created the world's first serological rapid tests for Tuberculosis to facilitate acid-fast bacilli microscopy for the identification of smear-positive and negative cases. Prevention of mother-to-child transmission of HIV was achieved in South East Asia by the use of rapid tests developed by Reddy in 1999. Reddy through his Corporation donated $173,050 worth of Rapid Diagnostic Tests (RDTs) for malaria in Zambia and actively participated in the prevention of child deaths due to Malaria infections. Reddy was personally invited by the president, George W. Bush, and First Lady Laura Bush to the White House for Malaria Awareness Day sponsored by US President Malaria Initiative (PMI) on Wednesday, April 25, 2007.

<span class="mw-page-title-main">Meningitis</span> Inflammation of the membranes around the brain and spinal cord

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 altered consciousness, nausea, vomiting, and an inability to tolerate light or loud noises. Young children often exhibit only nonspecific symptoms, such as irritability, drowsiness, or poor feeding. A non-blanching rash may also be present.

Meningococcal vaccine refers to any vaccine used to prevent infection by Neisseria meningitidis. Different versions are effective against some or all of the following types of meningococcus: A, B, C, W-135, and Y. The vaccines are between 85 and 100% effective for at least two years. They result in a decrease in meningitis and sepsis among populations where they are widely used. They are given either by injection into a muscle or just under the skin.

The Pilot Bioproduction Facility of the Walter Reed Army Institute of Research (WRAIR) is a Contract Manufacturing Organization (CMO) facility whose mission is to perform vaccine production on a pilot scale. The facility produces pre-license Phase I vaccine candidates under cGMP conditions using both bacterial and viral based technology. It is located at the Forest Glen Annex of the Walter Reed Army Institute of Research in Silver Spring, Maryland. Its business methodology is to work with government agencies through interagency agreements and with private companies through CRADAs in order to produce vaccine candidates. Its manufacturing capabilities include bacterial and viral seed banking, fermentation, purification, and aseptic filling. The facility can perform whole campaigns from beginning to end or any individual function listed above under GMP conditions. The facility also has the capability to perform different viral titer assays on a contracted basis. The Facility has a Type V Facility Master File on file with the U.S. Food and Drug Administration.

MenAfriVac is a vaccine developed for use in sub-Saharan Africa for children and adults between 9 months and 29 years of age against meningococcal bacterium Neisseria meningitidis group A. The vaccine costs less than US$0.50 per dose.

SynCo Bio Partners B.V. is a biopharmaceutical good manufacturing practices (GMP) contract manufacturing organization (CMO) located in Amsterdam, the Netherlands, licensed for clinical and commercial GMP manufacturing of bulk drug substances and drug products. SynCo offers a fully integrated range of biopharmaceutical development and manufacturing services supporting small biotech to large pharmaceutical organizations worldwide from the earliest stages in process development, through preclinical and clinical trials, approval and market supply.

Claire Veronica Broome is an American epidemiologist, specializing in public health surveillance and vaccine evaluation, who has contributed to the development and effective utilization of key vaccines against pathogens causing pneumonia and meningitis.

CRM197 is a non-toxic mutant of diphtheria toxin, currently used as a carrier protein for polysaccharides and haptens to make them immunogenic. There is some dispute about the toxicity of CRM197, with evidence that it is toxic to yeast cells and some mammalian cell lines.

<span class="mw-page-title-main">Vaccine ingredients</span> Ingredients used in a vaccine dose

A vaccine dose contains many ingredients, very little of which is the active ingredient, the immunogen. A single dose may have merely nanograms of virus particles, or micrograms of bacterial polysaccharides. A vaccine injection, oral drops or nasal spray is mostly water. Other ingredients are added to boost the immune response, to ensure safety or help with storage, and a tiny amount of material is left-over from the manufacturing process. Very rarely, these materials can cause an allergic reaction in people who are very sensitive to them.

Trudy Virginia Noller Murphy is an American pediatric infectious diseases physician, public health epidemiologist and vaccinologist. During the 1980s and 1990s, she conducted research at Southwestern Medical School in Dallas, Texas on three bacterial pathogens: Haemophilus influenzae type b (Hib), Streptococcus pneumoniae (pneumococcus), and methicillin-resistant Staphylococcus aureus (MRSA). Murphy's studies advanced understanding of how these organisms spread within communities, particularly among children attending day care centers. Her seminal work on Hib vaccines elucidated the effects of introduction of new Hib vaccines on both bacterial carriage and control of invasive Hib disease. Murphy subsequently joined the National Immunization Program at the Centers for Disease Control and Prevention (CDC). where she led multi-disciplinary teams in the Divisions of Epidemiology and Surveillance and The Viral Hepatitis Division. Among her most influential work at CDC was on Rotashield™, which was a newly licensed vaccine designed to prevent severe diarrheal disease caused by rotavirus. Murphy and her colleagues uncovered that the vaccine increased the risk of acute bowel obstruction (intussusception). This finding prompted suspension of the national recommendation to vaccinate children with Rotashield, and led the manufacturer to withdraw the vaccine from the market. For this work Murphy received the United States Department of Health and Human Services Secretary's Award for Distinguished Service in 2000, and the publication describing this work was recognized in 2002 by the Charles C. Shepard Science Award from the Centers for Disease Control and Prevention.

References

  1. "Development and Production of Low-Cost Vaccines". Clinton Foundation. Retrieved 10 August 2018.
  2. "New Page 15". Archived from the original on 2016-03-02. Retrieved 2015-09-18.
  3. "Home - PMI". Pmi.gov. Retrieved 10 August 2018.
  4. Pirkko Soundy; Bronwen Harvey; Ralph Rapley; John H. Walker (2005). Medical Biomethods Handbook. Humana Press. pp. 53–55.
  5. 1 2 Reddy JR, Kwang J, Lechtenberg KF, Khan NC, Prasad RB, Chengappa MM (January 2002). "An immunochromatographic serological assay for the diagnosis of Mycobacterium tuberculosis". Comparative Immunology, Microbiology and Infectious Diseases. 25 (1): 21–7. doi:10.1016/S0147-9571(01)00016-9. PMID   11831744.
  6. "JN-International Medical Corporation acquires vaccine facilities from Pfizer, Inc". Archived from the original on 2011-07-14. Retrieved 2009-02-09.
  7. "Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis - Full Text View". ClinicalTrials.gov. 11 January 2013. Retrieved 10 August 2018.
  8. "Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine - Full Text View". ClinicalTrials.gov. 16 April 2015. Retrieved 10 August 2018.
  9. "United States Patent: 8129147 - Meningococcal oligosaccharide linked polysaccharides and diptheria protein conjugate vaccine for all ages". Patft.uspto.gov. Retrieved 10 August 2018.
  10. "United States Patent Application: 0100173004". Appft.uspto.gov. Retrieved 10 August 2018.
  11. "United States Patent Application: 0090258397". Appft.uspto.gov. Retrieved 10 August 2018.
  12. "United States Patent Application: 0090252769". Appft.uspto.gov. Retrieved 10 August 2018.
  13. "Preventive and Therapeutic Vaccine for Stroke and Neurological Disorders". Patentscope.wipo.int. Retrieved 10 August 2018.
  14. Reddy JR, Kwang J, Varthakavi V, Lechtenberg KF, Minocha HC (October 1999). "Semiliki forest virus vector carrying the bovine viral diarrhea virus NS3 (p80) cDNA induced immune responses in mice and expressed BVDV protein in mammalian cells". Comparative Immunology, Microbiology and Infectious Diseases. 22 (4): 231–46. doi:10.1016/S0147-9571(99)00014-4. PMID   10465327.
  15. "Jeeri R Reddy Inventions, Patents and Patent Applications - Justia Patents Search". Patents.justia.com. Retrieved 10 August 2018.