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MANUFACTURING

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POLYSACCHARIDE VACCINE

Production of polysaccharides

Mr. Sridhar, Chief Scientist – Fermentation

Mr. Sridhar says that Nm Vac-4DT is a next-generation JN vaccine that will cover 4 different meningococcal Neisseria meningitidis serogroups collected by Scientific Director Jeeri R. Reddy, PhD, from Africa, Americas, Europe and Asia during 1990 through 1995. Among other complex production processes, the carrier protein that gives Nm Vac-4 DT some of its special characteris­tics is grown at our Omaha manufacturing facility, where the key focus is quality control, increased productivity and efficiency. The protein DT is isolated from the Corynebacterium diphtheriae bacterium, grown in large quantities, then separated from the bacterium and purified. “We’re expressing components of bacteria, then performing biochemical rearrangements or restructuring to actually make the vaccine work.”

Carrier Protein conjugation to polysaccharide Is the Key.

Dr. Seshu Gudlavalleti, Chief Conjugate Scientist.

Characterization and control of critical process steps in conjugate vaccine production Polysaccharide Activation. This involves, Degree of activation (colorimetric assays) Molecular size (SEC-MALLS), Critical substituent groups, e.g. o-acetyl or pyruvyl (NMR, colorimetric assays), Polysaccharide-Protein Conjugate, Saccharide:protein ratio (colorimetric assays), Free sugar (physical separation and colorimetric assays) Free protein and polysaccharides (SEC-HPLC), Molecular size distribution (size exclusion chromatography), Freedom from conjugate chemicals (colorimetric assays), Protein modification (amino acid analysis)

JNI cGMP & EU approved Vaccine manufacturing facility.
The state-of-the-art JNI manufacturing facilities are located at 2720, 2721 North 84th Street, Omaha Nebraska USA (65,000 ft2) and are in compliance with cGMP and the European Union. JNI has strictly controlled and fully equipped class 100 to 100,000 rooms to carry out manufacturing operations which are fully validated and controlled in all quality cGMP aspects. The facility has QC labs classified as Bio-safety Level-2. The facility houses multi-dose vialing stations and lyophilization equipment for bacterial polysaccharide products.
Over the past 15 years, new Neurological therapy candidates were placed into development, with 2 advancing to pre-clinical trials. Both are showing excellent potential.
Our Consultants:
Biologics Consulting Group, Inc trainer at JN facility with JN staff members listed below:
   
Ms. Ann Sutton, BCG
Mr. Jeff Harder, QC Director
Mr. Praveen Arpudha, Research Associate
Mr. Selom Agbobli, Environmental Associate
THE CONJUGATE VACCINE
   Regulatory Affairs
   Dr. Dana Orten
   Facility Management
   Mr. Charles Fritz
   Operations Director
   Mr. Peter Grotzinger