On the market of plasma-derived medicinal products, Kedrion has the skills and experience required to offer its technological know-how on:

• Production of one or more products
• Production of a whole product range
• Development or upgrading of production lines or fractionation plants

In these areas, Kedrion can offer:

• Technological Know-How
• Support to engineering companies
• Staff training and validation
• On-the-spot assistance during validation procedures as well as production follow-up once authorisations have been issued
• Copies of registration files, including clinical studies and viral validation studies, to be submitted to the authorities concerned to obtain marketing authorisations.

According to the customer’s requirements, such Technology Transfer can also include:

• Development of plant:
  1. Plant Layout review:
     Operation rooms (areas classification, pressure flow)
     Personnel flow, material flow (clean flow, dirty flow)
     Process flow diagram
     
  2. P&IDs review referring to instruments equipment and utilities
• Documentation:
  
  1. Raw Material and Auxiliary Material List
  2. QC/QA/Production Maintenance SOPs
  3. QC instruments list (in-process control & finished product control)
  4. Product/Process/Intermediate Specifications
  5. Packaging Specifications
  6. BPR (Batch Production Records)
  7. VMP
  8. IQ/OQ/PQ protocols::
     Environmental
     Utilities
     Equipment
     Instruments
     
  9. QC Methods Validation
  10. Process Consistency Protocols:
      Upstream Process(Fractionation & Purification)
      Downstream Process (Filling)
      
  11. Cleaning Validation Protocol (CIP; SIP; COP)
  12. Safety Data and risk assessment
  13. Finished product/ Intermediates Stability data
  14. Accelerated Stability Data (if required)
  15. Registration Dossier referring to each product
• Validation
  
  1. DQ/IQ/OQ Activities (supporting)
  2. PQ Activities-responsibility to execution
  3. DQ/IQ/OQ/PQ Final Reports issue  (supporting)
  4. documented verification that the facilities, the equipment, as installed and operated, and the production environment, are in compliance with the Technological Process and the Know-how, and demonstrating all the above is capable to produce the semi-finished and finished Products based on and/or in conformance with the Technological Process, Specifications, the Registration Dossier and the Know-how.
  5. documented verification that the Know-how has been transferred to the Customer, the equipment has been purchased and successfully installed according to the Technological Process in a manner  enabling effective production of the Products
  6. documentation that 3 (three) consecutive successive test run batches for each  product have been produced successfully, to give evidence of the consistency between the two productions/products (i.e. customer site production/products vs. Kedrion production/products)
• Regulatory Support (optional)
  
  1. Supporting during the Health Authority Inspection
  2. Supporting during the Health Authority Registration Dossiers Evaluation
• Staff training in the following four areas:
  
  1. production (upstream-downstream; sterile production)
  2. QC
  3. Maintenance, clean rooms
  4. QA, GMP, GLP

CONTRACT MANUFACTURING

Kedrion  is performing Contract Fractionation of plasma of all the plasma belonging to Italian regions: the plasma is collected in public transfusion centres, managed by the various Regional Health  bodies, was given to kedrion for the manufacturing of plasma-derived products, of which Kedrion holds the Marketing Authorization.
The service of Kedrion includes:

• the  transportation of plasma from any  Collection Centre to the Plant,
• the control and storage the plasma in the right conditions,
• the fractionation of the plasma and the preparation of the plasma-derived pharmaceutical products,  to be held separated from the processing of plasma of different origin,
• the transportation of the total amount of products manufactured from plasma to Regional Boards Storehouses.
• The overall organization and planning of the services, according with regional plasma collection and products need.

For this type of service Kedrion receives a manufacturing fee per each litre of plasma processed.

Kedrion is willing to expand this long and fruitful experience to other Customers, which include Foreign Public Health Services or Private Companies.

A different mechanism of remuneration of the Service can be agreed upon, with the possibility for the Customer to leave a portion of the derived products to Kedrion as partial or total payment of the Manufacturing fee.