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Transfer of Technology (ToT) best practices and tools.

Technology transfer, or Tech Transfer a.k.a. transfer of technology (ToT), is a process in which technology or knowledge developed at one organization is transferred to another, typically for the purpose of commercialization.

 

Through this process, a donor site (either a product’s sponsor or a manufacturing site) transmits proprietary knowledge and experience about a product, the associated manufacturing processes, and/or the relevant analytical methods to a receiving manufacturing site. This allows the receiving site to carry out the necessary activities to produce the product at the appropriate scale for the stage of development.

 

Technology transfer may include the movement of data, designs, inventions, materials, software, technical knowledge, or trade secrets from one organization to another or from one purpose to another. The technology transfer process is guided by the policies, procedures, and values of each organization involved in the process.

 

Technology transfer can be done between universities, businesses, and governments, to share skills, knowledge, technologies, manufacturing methods, and more. This form of knowledge sharing helps ensure that scientific and technological developments are available to a wider range of users who can then help develop it.

 

However, before innovations can be brought to market they need to be developed through technology readiness levels (TRL). TRLs 1-3 focus on research while levels 6-7 and higher sees a product move towards production. Bridging the gap between these different levels can be complex and time-consuming, as it requires the development of research into prototypes and then to fully tested and reliable finished products.

 

An important part of tech transfer is the protection of intellectual property (IP) associated with innovations developed at research institutions. This can mean licensing patented intellectual property to outside businesses or the creation of start-up companies to license the IP.

 

Commercializing technology requires the ability to identify potential markets, develop products that satisfy those needs, and manage distribution channels. The ability to transfer technology and develop innovative products is a key component of business success. It is through this mechanism that cutting-edge goods can get onto the market, allowing a firm to generate income and prosper. Technology transfer is important to ensure that the company’s innovation becomes commercialized.

 

This helps early-stage intellectual property to become tools for research. It can also be used as a base for new products and services for public use. In addition, the financial returns afforded by a successful product can be reinvested into further research to begin the cycle again.

 

Technology transfer is particularly important to SMEs, who are able to leverage outside expertise and research to develop and create new innovations that are ready for the marketplace.

 

How Technology Transfer Works

The technology transfer process typically starts with technology identification, followed by contractual agreements between parties, such as licenses to use protected IP.

 

In industrial settings, technology identification is the first step in the technology transfer process, and it can be accomplished through a variety of methods including reverse engineering, researching patents for new inventions, scanning journals for technological advancements, performing company inventories to see what technologies are available within your organization or doing market research to see what kind of products consumers would like you to create. Once identified, these technologies may be included in either license agreements or be transferred from one company to another.

 

Technology licenses involve providing rights to use within certain territories and time frames but not transferring ownership between parties. In contrast, technology transfers involve exchange of ownership as well along with intellectual property rights.

 

In university technology transfer, by far the most usual practice involves the issuance of licenses from the university to a commercialization partner, the licensee. Universities are typically prohibited from transferring outright ownership of their IP to outside parties.

 

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. This process is common with university-related inventions because universities are not in charge of manufacturing the inventions themselves, but they want to get their inventions out into the market

Market pull. This is when new technologies are developed in response to demand for a product or service. This is the most common way of technology transfer as it pulls up innovation in order to meet the demands of the market.

Technological spillover. This takes place when new advances in one area stimulate progress in another. It’s called a “spillover” because it’s like ideas spilling from one subject to another, or technology being transferred between countries.

 

Technology transfer management

Technology transfer management is a challenge for any company, especially the organizing and communication segments. Technology transfer typically adopts a three-tier organizational structure. The first level is high level committee of the sending unit, which is responsible for decision-making, budget, timeline and approval of major changes of the technology transfer project.

 

The second level contains the project manager and the heads of each function, who are mainly responsible for project management and problem solving.

 

The third level is the front-line personnel of each functional group. It is important that a technology transfer team be comprised of cross-functional subject matter experts, and the role and responsibilities of each team member should be clearly defined. Both the donor and receiving sites must have personnel from several disciplines involved, including R&D, manufacturing, quality assurance, quality control, regulatory affairs, construction, finance, supply chain, legal and EHS department, mainly to solve the technical problems of each module

 

A close relationship and good communication between the donor and receiving sites is also key for a successful technology transfer and a fruitful long-term relationship, which can last for the entirety of product development and into the commercialization stage.

 

Technology Transfer Documentation and Information

The donor and receiving sites must gather and prepare several documents to ensure a successful technology transfer:

  • Technology transfer plan: This describes all the activities to be transferred, the steps to be taken for the transfer, the responsibilities of each group at each site, and the expected outcome.
  • Detailed analytical methods: Analytical methods are one of the first elements of a manufacturing process to be transferred. They are also the foundation of technology transfer success because the results of the analyses are used for comparability assessments.
  • Manufacturing process description or batch: The manufacturing batch record is the most crucial document in describing the manufacturing process. It is imperative that it be clear, detailed, well-written, and thoroughly reviewed by the donor site for a seamless manufacturing process transfer with all key details transferred appropriately. The manufacturing process transfer team should always include a technical specialist from the donor site, as sometimes the know-how is not well-documented in the batch record.
  • Critical process parameters (CPPs): According to ICH Q8(R2), CPPs are parameters that should be monitored or controlled to ensure that a product is of the desired quality. They are generally identified by assessing the extent to which their variation could impact the quality of the drug product. The CPPs and any other important parameters must be identified and taken into account for a successful transfer.
  • Critical quality attributes (CQAs): Per ICH Q8(R2), a CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. Having an understanding and control over the product’s CQAs is important during a technology transfer.
  • Technical gap analysis: This is a formal documentation of the assessment of known and potential gaps between the donor and receiving sites’ capabilities and of their readiness for the transfer. For example, the analysis will determine if the receiving site has appropriate equipment in place to perform the transferred manufacturing process or analytical methods. The document should include a risk assessment.
  • Adequate change control management system: Any changes or adjustments made to the process or equipment should be documented, assessed, and justified with regards to their potential impact on the CQAs and the Quality Target Product Profile (QTPP).

 

Execution and Verification of Technology Transfer

A technology transfer plan should be executed in stages as appropriate, with documented evidence that each stage is complete before the next stage starts. As an example, the manufacturing of a small-scale batch should be completed, with acceptable results, before an engineering batch at the intended manufacturing scale is produced. The same logical steps should be performed for an analytical method transfer, with familiarization runs being performed and documented before validation runs begin.

A successful technology transfer should always be documented. There should be evidence that the receiving site can routinely reproduce the transferred product, process, or method against a predefined set of acceptance criteria as described in the technology transfer plan, and such evidence should be produced with reference to the product’s QTPP and CQAs. Finally, a comparability assessment is usually performed to confirm the successful completion of the technology transfer.

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