The ICH Q10 guidance explains that the goal of technology transfer (TT) activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.
Technology transfer helps manufacturers expand pharmaceutical production by bridging gaps in knowledge, whether around process, capabilities, or equipment, to elevate and optimize the quality and output of medical products. Mivado GlobalPerformance specializes in assisting and supporting the TT process by assessing the potential for and facilitating knowledge transfer between innovators and recipients while de-risking the process for all parties. Technology transfers are voluntary collaborations between businesses to exchange knowledge, and know-how, and show how to develop essential medicines and vaccines based on expertise, experience, and trust.
The transfer of advanced technology is essential for economic development. It enables countries to accelerate the acquisition of knowledge, experience, and equipment related to advanced, innovative industrial products and processes.
Technology transfer services can be broken down into two main categories: transferring technical skills and knowledge, and transferring technology itself (like inventions or intellectual property).
Our TT Specialists routinely support global Biopharma Company through the following activities:
TT Process Development Stage
- Market validation: Assess the commercial potential of a new technology.
- Marketing strategies: Develop a plan to bring the technology to the attention of potential licensees or partners.
- Identifying and vetting potential licensees: Find companies that would be a good fit to license or acquire the technology.
- Developing marketing materials: Create brochures, presentations, and other materials to showcase the technology.
- Negotiating licensing agreements: Structuring deals that benefit both the technology owner and the licensee.
TT Process Implementation Stage
- Defining and Scoping: Determining what exactly needs to be transferred and the timeline.
- Planning: Setting up a team with representatives from development, manufacturing, quality control, and regulatory affairs.
- Execution: Transferring documentation, training personnel, and performing trial runs of the manufacturing process.
- Validation: Demonstrating through testing that the transferred process can consistently produce a high-quality product.
TT Process Execution & Performance
- Create and revise standard operating procedures for production, as well as create and revise procedures for new equipment and batch manufacturing;
- Assist in the New Product Introduction (NPI) process.
- Work with Product Development to develop process knowledge.
- Work with engineering to develop equipment process parameters and process workflow.
- Assist in the creation of work instructions and job aids, and train manufacturing operators.
- Assist in developing manufacturing equipment improvements, quality improvements, and line performance improvements;
- Identify process deficiencies and recommend corrective improvements;
Technology transfers are a recurring hurdle for drug products. They’ll take place at numerous points in the product’s life cycle, both between your organization and your CDMO and within your CDMO’s facilities.
Transferring technical skills and knowledge focuses on equipping a workforce with new capabilities. Here, some services you can provide include:
- Online learning: Developing interactive training programs for employees to acquire new skills.
At Mivado GlobalPerformance, we have the experience and processes needed to streamline and de-risk your transfers. Our fully integrated solutions and teams allow optimized transition of drug products and their specific processes, between and within your development and production environments.
