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 obtain vaccines and diagnostics for developing countries.  

In our State-of-the-Art Research & Development facility, JN has strictly controlled and fully equipped biological safety areas of Level-3, class 10,000 to carry out high performance operations which are fully validated and controlled in all quality research aspects. All the operations at JN are in the process to conduct under well documented standard operating procedures. In addition to external and internal audits, plus an exhaustive process validation plan on its way, JN's Quality Systems is in the process to guarantees safe and efficient products, which is key to JN' success.

Our facilities include bacterial fermentation and cell cultures with specified upstream and downstream processing areas with 24/7 video recording installed to locate each spot of the facility and the human moment. A dual New-Brunswick bioreactors (250 Liters x 2 = 500 Liters) run with continuous supply of clean air, water and stream to ensure sterility in-process product manufacture. Bioreactors can be operated remotely during entire cycle of fermentation. During upstream process, a bioreactor attached to high speed Sharpel continuous centrifuge (400L/hr) and in turn cooled by polyethylene glycol chiller to protect the product degradation. The utilities and Equipment shall have direct contact with the product are made out of high-grade stainless steel. Downstream research labs equipped with Millipore / Sartorius filtration system (30K - 100K), HPLC, Sorval evolution centrifuges and a Labconco Freeze dryer. All the equipments are in the process of validation (IQ/OA/PQ) by an expert engineering Boston  (Biomatrix Corp). Entire facility is operated by validated and certified by Lewis Testing Services, Inc. Indianapolis.  Thw HEPA-filteration system categorized as grade-A that covers 3000/sq.ft., with 40 filters (IEST-RP-CC-002-86), which create positive pressure with less than <1000K particles /sq.ft. Well-trained and experienced scientists (PhDs, MD and Fermentation Engineer, trained and certified QA/QC) working in full compliance with international quality standards.  Work force follows a strict dress code and air showers disinfect system at each part of process. The facility and equipment are product specific  with clean-in-place (CIP) for each cycle. Bulk raw material for the production are purchased from cGMP manufacturers in the US as per Quality Assurance Project Plan (QAPP).  The process of production is in the process of validation by QAPP.  EPA regulations are fully enforced at JN facilities for discarding of regulated and un-regulated waste.  The facility is designed and constructed by well-experienced MCGINNIS ENGINEERS of Omaha using the special material made in USA . 

The facility is now ISO 9001:2000 Certified (ITC). JN facilities are in the process to comply with 21CFR and expected to be completed by 2010.