Technology Transfer

Your project consists of either moving from R & D to production, or repatriating an injectable or biotechnological product that you prefer to subcontract or outsourcing your production to another factory. Axys Network provides the best solution to secure good technology transfer from the first time, to save time and improve time to market as well as allocate only the resources necessary for your transfer

Support for Transfers by Experts in Aseptic Processes

Objectives & Scope

  • Define the scope of intervention, the objectives and the responsibility for liberation
  • Collect the necessary information and data
  • Determination of the critical points of the transfer

Transfer Organisation 

  • Establishment of transfer teams from both parties
  • Different stages of technology transfer
    • Quality design
    • Scale-up
    • Detection of quality variability factors
    • Validation and production phase
    • Transfer of documents

Operational phase

  • Change control review with risk assessment
  • Pro and Con's technical choices

  • VMP and process validation transfer strategy
  • Examination of qualification batches
  • Documentation review
  • Regulatory review
  • Submission coordination