What are the steps of technology transfer process?
Technology Transfer Process
- Step 1: Invention Disclosure.
- Step 2: Evaluation.
- Step 3: Patent Application.
- Step 4: Assessment and Marketing.
- Step 5: Licensing of Patents.
- Step 6: Commercialization.
What are the process of technology transfer in pharmaceutical industry?
Key stages of the process include data collection, data review, regulatory impact with particular emphasis on any change approvals, analytical validation, pilot or full-scale process batch, stability set down (if required).
What are types of technology transfer?
Technology transfer can be categorized into three basic types:
- Technology push. This takes place when a company or university patents its invention and licenses it to other companies.
- Market pull. This is when new technologies are developed in response to demand for a product or service.
- Technological spillover.
What is TT in industrial pharmacy?
Technology transfer (TT) is a structural guideline that is intended for the quality of the process, products, standardization, and cost-effective productions.
What is technology transfer example?
Technology transfer is the innovation management that takes a novel invention from public laboratory—such as a university, hospital, or federal research team—to commercialization.
How does the process transfer process work?
The process transfer team closely monitors the process execution, in process results, and operational observations during the first process batch manufacturing campaign. The process results provide early indication of the process transfer success and identify requirements for changes prior to subsequent batch manufacturing, if applicable.
How many stages are there in the technology transfer process?
The technology transfer process has been simplified into four stages described in more detail below. The technology transfer process ideally starts early during the process development life cycle. Best practices can be incorporated into early stage development (Phase I) long before facility selection.
How can I improve the technology transfer process?
Continued manufacturing process performance, deviations, and post-approval changes from the receiving site continue to inform the technology transfer process (Step 1 and Step 2) for future process transfers. This feedback is key to continue to optimize and improve the technology transfer process.
What should be included in a process Transfer Plan?
Long lead deliverables and scope (Facility/Equipment modifications, raw material procurement/release) A formal process transfer plan is useful to document and clarify the process transfer objectives, deliverables, timeline, process transfer team responsibilities, and provide an overview of the risks with associated mitigations.
