Tech transfer

A vast experience in technology and manufacturing transfers

Sever Pharma Solutions has vast experience with different types of technology transfers:

• from the customer’s R&D to Sever Pharma Solutions’ R&D
• from the customer’s R&D to Sever Pharma Solutions’ production
• from the customer’s production to Sever Pharma Solutions’ production
• from Sever Pharma Solutions’ production to someone else’s production.

Our transfer procedures align with each service’s ISPE Good Practice Guide: Technology Transfer.

Sever Pharma Solutions’ track record in technology transfer includes numerous cases where the sending party cannot or unwillingly support the transfer process properly. In such instances, our project team applies statistical process control on raw historical data to gain the appropriate level of process understanding.

PROCESS TRANSFER

Sever Pharma Solutions has developed a structured approach to manufacturing transfer. It incorporates many fundamentals of good project management and Quality by Design philosophies (to enhance process understanding). The steps typically include:

• A historical review of the sending unit’s process to assess its repeatability and robustness.
• A regulatory review to assess compliance between the regulatory file and the actual process.
• Training in analytical methods and processes (using the historical review as a base).
• Analytical method transfer (see below).
• Process validation (based on conclusions from the historical review)

Typical transfer acceptance criteria include:

• Conformance to release specifications.
• Acceptable level of statistical control of the receiving unit’s process
• The similarity between the receiving and sending units’ processes.
• Transfer of analytical methods

In our experience, more variation is associated with the transfer of testing methods than the actual process transfer. As the receiving unit, Sever Pharma Solutions needs to adopt, substitute or supplement the sending unit’s methods. This requires comprehensive training and validation of these methods, based on the ISPE Good Practice Guide: Technology Transfer.