MANUFACTURE

 

 

 

 

 

 

 

 

 

 

 

cGMP & EU approved Vaccine manufacture facility (former Pfizer facility )

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. JNI has the capacity to produce 10,000-doses per day. The vaccines are in process of regulatory approval. The Facility at 2720 has finished basement (20,000 sq.ft.) is designed to accommodate cell cultures. JN has been trying on novel technologies for high-yield and cost-effective production of vaccines. This ambitious projects are a clear example of the strategic vision of JN, that relying on the so called XXI Century technologies, directs its best efforts towards the development of novel methods to develop neurological vaccines. 

Polysaccharides

Mr. Sridhar V,

Fermenation Engineer

Explains that the polysaccharides from vaccine producing serotype of Neisseria meningitides are produced in 4 separate bioreactors and purified polysaccharides are chemically activated and then linked with the carrier protein through another biochemical process. Each of the 4 resulting glycoconjugates is purified. All along the way, quality control tests are used to make sure batches are consistent and remain sterile. Finally, the 4 glycoconjugates are combined to complete the formulation. The final formulated bulk vaccine isfilled into vials and packaged at a number of sites in the United States, Brazil, South Asia and Africa for distribution around the world.

 Currently the number of large players in the vaccine industry worldwide is limited to less than a dozen.

  Polysaccharides 

Carrier Protein conjugation to polysaccharide Is the Key

Dr. Seshu Gudlavalleti Chief Conjugate Scientist.

Dr. Seshu says that 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.” The result, at least for Nmvac-4 DT and for a next-generation JN vaccine that will cover 4 different meningococcal production clones 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.

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.

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.

 

  The Conjugate

The Conjugate

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)

 

Mr. Charles F, Facility Engineer

Mr. Peter Grotzinger, Administration  

Dr. Jeeri R Reddy, who heads the Company’s Global Vaccines research & business unit, says “JN has played a leading role in the inventing of some of the most significant vaccine advances over the last 2 decades, and our commitment and excitement about vaccines today are stronger than ever

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