State-of-the-Art Vaccine facility

 

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 located at Starwood Biotech Business Park, JN has strictly controlled and fully equipped for class 10,000 to carry out high performance operations which are fully validated and controlled in all quality research aspects. The facility has microbiological labs classified as Bio-safety Level-3, Large Scale CDC-NIH (BL3-LS). 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. The facility is designed and constructed by well-experienced MCGINNIS ENGINEERS of Omaha using the special material made in USA .  The Starwood facility is now ISO 9001:2000 Certified (ITC). 

The Maple Street facilities (87,000 sq.ft.) located in 2 building were designed for manufacture of human vaccine incompliance with cGMP and European Community standards with classification from 100 -10,000-100,000 air handling systems in place. The facility has large scale fermentation. The facility includes formulations and lyophilization or cryodesiccation bacterial polysaccharide products. Utilities include compressed air system (USP), clean steam system, process chilled system and Clean-in-Place systems. The facility has dedicated WFI water system. Kill tanks for neutralizing waste water. 

Processes include; seed bank, media preparation, fermentation, cell harvest, centrifugation and purification including ultra filtration. The facility is designed for operating in a campaign fashion with decontamination and fumigation performed between each test batch production. Maplewood and Starwood facility include bacterial fermentation and cell cultures with specified upstream and downstream processing areas with 24/7video recording installed to locate each spot of the facility and the human moment. A dual New-Brunswick bioreactors (1000 Liters x 4 = 4000 Liters)  with continuous supply of clean air, water and stream to ensure sterility in-process product manufacture. The Bioreactors totally computerized with Allen-Blandly remote operation system in place to control during entire cycle of fermentation from scientists office. During upstream process, a bioreactor attached to high speed Sharpel continuous centrifuge (400L/hr x 2) 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 two  Freeze dryers and validated vial stations located in each building. Dedicated shelf space for initial development and  freeze drying with robotic loading/unloading to minimize handling and microbial exposure.

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.  The HEPA filtration system categorized as grade-A filters (IEST-RP-CC-002-86), which create positive pressure with less than <100-1000K 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.