To address the increasing demand for vaccines, recombinant products, injectable solutions, and laboratory animals, the Reseacrh and Production Complex commenced its operations in 1988. Over the past century, the Pasteur Institute of Iran has effectively managed various infectious diseases, such as smallpox, cholera, rabies, hepatitis B, and tuberculosis, through the production of a wide array of vaccines and impactful health interventions. What is more, the institute has developed vaccines for typhoid, anthrax, gonorrhea, and typhus, with plans underway to manufacture pneumococcal and rotavirus vaccines. During the COVID-19 Pandemic, alongside launching a diagnostic laboratory network for the coronavirus in the country, the Pasteur Institute of Iran produced PasteuCoVac vaccine in a short time in collaboration with the Finlay Institute of Cuba.

The complex situated on the Tehran-Karaj highway currently produces a range of products, including B.C.G, Hepatitis B, and animal rabies vaccines, as well as PastoCys (Freeze-dried Intravesical BCG), injectable solutions, bacterial antigen kits, and laboratory animals. All products from this complex adhere to current international standards for production and quality control, enabling them to meet the demands of international markets.

The deputy of production is one of the key deputies of the institute, who, in addition to managing production matters, is also the head of the research production complex and incubation center. Based on the role played in the production chain, production, quality and supply tasks in this vice-chancellor should be carried out in 5 areas:

 

1. Planning and production management includes 8 production lines indifferent fields.

2. Commercial management includes marketing, supplying materials and

3. Quality manager includes quality control (Labs) and quality assurance

4. Technical engineering includes maintenance of equipment and utilities

5. Logistic managements including warehouses, general services, administrative and   welfare affairs  

 

Objectives and Strategies:

  • Planning for over national demand  in order to export
  • Contract manufacturing
  • Manufacturing new products, including vaccines and health-promoting products for the community
  • Managing incubation center
  • Emphasis on products with economic value-added
  • Implementing cost benefit strategy
  • Adoption of technology transfer methods
  • Development of technological cooperation with foreign or domestic firms

 

The Research and Production Complex consists of the following departments:

 

Production Lines

B.C.G and related products

  • Products: BCG vaccine andPastocys
  • Capacity: over national demand
  • Facility Specifications: Lyophilization ,  homogenizer, autoclaves , Formulation And Filling and packing, Clean rooms(A,B,C, D)

Yeast based recombinant

  • Products: Hepatitis B vaccine
  • Capacity: over national demand
  • Facility Specifications: Fermenters, centrifuges , Cell disruptions, industrial scale chromatographic systems and filtration systems, clean room class (A,B,C,D)

Viral Vaccines

  • Products: Animal rabies vaccine
  • Capacity:  up to national demand
  • Facility Specifications: bioreactors, Filtration and cleanroom(A, C ,D)

Injectable Solutions

  • Products: Sodium chloride 5%, potassium chloride 15%, magnesium sulfate 20% and 50%, dextrose 20% and 50% , Lidocaine  hydrochloride 2%
  • Capacity: part of national demand
  • Facility Specifications: 50 ml glass vial, washing machine , filling , visual inspection ,labeling, etc.

Diagnostic kits

  • Products: wright antigens , Rose Bengal antigens, 2ME, Widal, vibrio chlora antisera ,viral transport Medium(VTM), Blood culture medium
  • Capacity: National demand
  • Facility Specifications:

Laboratory Animal Facility

  • Products: Rat, Hamster, Rabbit, Mouse, Rat  and Guinea pig
  • Capacity: national demand
  • Facility Specifications:

Formulation, Filling and Packaging

  • Products: F.F.P. of Hepatitis B , Animal rabies , Pastocovac Vaccines and contract manufacturing
  • Capacity: Over national demand
  • Facility Specifications: Formulation, filling , packing and Labeling Facilities, Clean room(A,B,C,D)

Mammalian cell production line

  • Products:Pastocovac, Pastocovac Plus
  • Capacity: National demand
  • Facility Specifications: Bioreactors, Filtration systems, Industrial Chromatographic systems , Clean room (A,B,C, D)

 

Quality Management

Regulatory affairs

  • Pharmacovigilance
  • Periodic Safety Update Report (PSUR)
  • Risk Management
  • Production Release

 

Quality Control

  • Sample Reception Office
  • Water and Raw Material Lab
  • Physical Chemistry Lab
  • Microbiology Lab
  • Bioassay Lab
  • Molecular and Cellular Biology Lab
  • Animal Testing Lab
  • Chromatography / Electrophoresis Lab

 

Quality Assurance

  • Documentation
  • Inspection and Audit
  • Validation, Change control
  • Batch Release
  • Supplier Evaluation, CAPA
  • Recall, Compliance

 

Equipment and Facilities Maintenance

  • Equipment and Calibration Department
  • Water and Sewage Department
  • Facilities and Building Department

 

For more information, please visit: http://en.pasteur-prc.ir/  

 

last update: Oct 29 2024