Technology Transfers are a challenging and critical part of the Drug/Biologic/Device development process. They involve the transfer of skills, knowledge, technologies, materials, and manufacturing methods.
Technology Transfers ensure that scientific and technological developments are scaled up and/or transferred to different locations under different ownership, creating access to a wider range of users. They are closely related to (and may arguably be considered a subset of) knowledge transfer.
The core objectives of the Tech Transfer process are as follows:
- Manufacturing - Demonstrate repeatability and robustness. Comply with process specifications . Meet HSE requirements.
- Drug Product - Demonstrate the similarity of the products before and after transfer. Comply with testing specifications. Meet regulatory and safety requirements.
- Analytics - Move the methodology between facilities. Verify and validate the methods. Qualify the lab.
- Regulatory - Obtain license approval. Market the product.
- Business - Assure continuity of commercial production. Meet strategic targets (cost, timeline & capacity drivers)