MANUFACTURE

cGMP & EU approved Vaccine manufacture facility

(former Pfizer facility - Press release)

The State-of-the-Art JN manufacturing facilities are located at 2721, 2720, 2724 at 84th street (56,000 sq. ft) and are in compliance of cGM, BSL-2 and 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-3, Large Scale CDC-NIH (BL3-LS). The facility houses multi-dose vialing station and lyophilization equipment for bacterial polysaccharide products.

Manufacturing One of the Most Complex Vaccine

Dr. Jeeri Reddy, President and Scientific Director.

Dr. Reddy says  the challenge for the vaccine manufacturer is to increase productivity, maintain adherence to regulatory requirements and evaluate novel platforms and technologies to stay current. In addition to the technological advances of the field, the increased importance of both U.S. and international regulatory agencies will be addressed as well as the latest in FDA guidance documents and their impact on current production. Our consultants (former FDA heads) are helping us to the regulatory requirements.

Learn more about our Founder & the President at Wikipedia

  Polysaccharides 

Production of polysaccharides

 

Mr. Sridhar Valkapudi, Fermenation Engineer

Mr. Sridhar says that Nmvac-4 DT and for a next-generation JN vaccine that will cover 4 different meningococcal production Neisseria meningitidis serogroups collected by Jeeri R Reddy, PhD, Scientific Director from Africa, Americas, Europe and Asia during 1990 through 1995. Among other complex production processes, the carrier protein that gives Nmvac-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. Which 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)

 

  The Conjugate

Research and Development

Dr. Dana Orten, Director Research and Development

Dr. Orten qualifies Formulation development’s roles:  Develop a formulation that is safe, stable, robust, and cost effective, Define formulation conditions for DS and FP,  Using approved excipients, Select appropriate, container/closure, Compatibility with product. Container closure integrity, Convenience for shipping and storage, Evaluate storage/stability and Evaluate accelerated (and stress) and real-time data. Liquid formulation challenges conjugate vaccine: Potential factors that could affect stability, Chemical instability, Hydrolysis of Polysaccharide antigens, Fragmentation of protein carrier, Physical instability (process related), Aggregation.

Management

Mr. Charles F, Facility Engineer

Mr. Peter Grotzinger, Manager 

 

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