JN-International Medical Corporation

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JN-International Medical Corporation
Type Private
Industry Biopharmaceutical
Founded 1998
Headquarters Flag of the United States.svg Omaha, Nebraska
Key people Dr. Jeeri R. Reddy, Founder
President & CEO
Products Vaccines, Diagnostics
Subsidiaries JNI Medical Corporation Coted'Ivoire
Website http://www.jn-vaccines.org

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,[1] the Global Business Coalition, New York[2] President's Malaria Initiative and PEPFAR.[3][4][5] JNI also partners with several other non-profit global health organizations,[6][7] 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.

History[edit]

Early in its existence JNIMC developed rapid and western blot[8] 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.[9] 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[edit]

JN-International global headquarters in Omaha, Nebraska, United States

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.

Vaccine facilities[edit]

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 82,000 ft² and will include a 20,000 ft² fully automated unit. The facility has a targeted production of 60 million doses of vaccine annually.

Acquisition[edit]

In January 2009, JNIMC acquires Biocor vaccine manufacture facilities, a subsidiary of Pfizer Inc in Omaha.[10] 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[edit]

The following is a list of key Vaccine products. The names shown are all registered trademarks of JN International.

  • NmVac4-A/C/Y/W-135 Meningococcal meningitis vaccine for prevention of Meningococcal meningitis serogroups A, C, Y and W-135 disease.
  • NmVac4-A/C/Y/W-135 - DT 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.[11] and [12]

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 falciparum Plasmodium vivax Plasmodium malariae Plasmodium ovale
  • 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 falciparum
Vaccine Phase Action
Stroke Non-IND Phase I clinical trial For prevention and Therapy for Transient Ischemic Attack (TIA), Epilepsy and Transient Ischemic Stroke.
Hepatitis C Pre-clinical development For prevention for Hepatitis C genotype-1.
Genital Herpes Pre-clinical development For prevention of Genital Herpes.
Tuberculosis Pre-clinical development For prevention of TB.

Patents & Publications[edit]

JNI patents and publishes Journal articles of its research and technologies in the field of human Infectious Diseases and Neurological Disorders[9][13][14][15][16][17][18]

External links[edit]

References[edit]

  1. ^ William J. Clinton Foundation: Clinton Global Initiative http://www.clintonglobalinitiative.org/commitments/commitments_search.asp?Section=Commitments&PageTitle=BrowseandSearchCommitments&id=219202
  2. ^ The Global Business Coalition on HIV/AIDS, Tuberculosis and Malaria (GBC) http://www.gbchealth.org/member_profiles/229-jn-international_medical_corp./?words=jninternational
  3. ^ RAPIDS Malaria Initiative: 2007 Final Report” http://www.fightingmalaria.gov/news/photo_galleries/africa/photo_184.html
  4. ^ President's Malaria Initiative: http://www.fightingmalaria.gov/
  5. ^ President's Emergency Plan for AIDS Relief: http://www.pepfar.gov/
  6. ^ International Aid + Trade.http://www.aidandtrade.org/
  7. ^ The Global Health Council. http://www.globalhealth.org/
  8. ^ Pirkko Soundy and Bronwen Harvey. Rapley, Ralph; Walker, John H. (eds.) (2005). Medical Biomethods Handbook. Humana Press. pp. 53–55. ISBN 978-1-59259-870-0. 
  9. ^ a b 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. 
  10. ^ Omaha World-Herald. Friday, January 30, 2009. JNIMC acquires vaccine facilities from Pfizer, Inc. http://www.mmdnewswire.com/jn-international-4537.html
  11. ^ http://www.jn-vaccines.org/11680471_Notice_of_allowance.pdf
  12. ^ http://jn-vaccines.org/US20100297166_1.PDF
  13. ^ Jeeri R Reddy. Method of producing meningococcal meningitis vaccine for Neisseria meningitidis serotypes A,C,Y, and W-135. United States Patent Office (USPTO) http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=%22REDDY,+Jeeri%22&OS=
  14. ^ Jeeri R. Reddy. PREVENTIVE AND THERAPEUTIC VACCINE FOR STORKE AND NEUROLOGICAL DISORDERS. http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=2&f=G&l=50&co1=AND&d=PG01&s1=%22Jeeri+R+Reddy%22&OS=
  15. ^ Jeeri R. Reddy, Preventive And Therapeutic Vaccine For Huntington's Disease http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=3&f=G&l=50&co1=AND&d=PG01&s1=%22Jeeri+R+Reddy%22&OS=
  16. ^ Jeeri R Reddy. PREVENTIVE AND THERAPEUTIC VACCINE FOR ALZHEIMER'S DISEASE. http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=4&f=G&l=50&co1=AND&d=PG01&s1=%22Jeeri+R+Reddy%22&OS=
  17. ^ REDDY Jeeri. Preventive and therapeutic vaccine for Stroke and Neurological disorders http://www.wipo.int/pctdb/en/wo.jsp?WO=2008121146
  18. ^ 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.