Best ever guideline about Technology transfer Each and everything you need to know
What are the guidelines for technology transfer?
Transferring technology is an essential part of the drug development process. A sponsor might seek a contract development and manufacturing organization (CDMO) for clinical trial manufacturing, transfer a manufacturing process to a bigger, commercial-scale CDMO, or replace a CDMO with quality difficulties. These are valid reasons for looking for a CDMO. How technology transfer is managed can impact the success of a product’s development and commercial manufacturing experience.
The Concept of Technology Transfer Examined.
According to the WHO’s standards (TRS 961, Annex 7), the definition of technology transfer is “a systematic procedure that is followed to pass the documented knowledge and experience gained during development and commercialization to an appropriate, responsible, and authorized party.”
A manufacturing site that either sponsors a product or a production site can act as a donor to another to facilitate the transfer of confidential information and expertise about a product, the associated manufacturing processes, and the relevant analytical procedures. Because of this, the receiving site can carry out the operations necessary to make the product at a scale acceptable for the development stage.
The Objectives of Technology Transfer.
The following is an explanation of the goal of technology transfer provided by the ICH Q10 guidance:
The objective of actions about technology transfer is to realize product realization through transferring product and process knowledge between the stages of product development and manufacture, as well as within or between manufacturing locations. This information serves as the foundation for the manufacturing process, control strategy, approach to process validation, and continuing continuous improvement.
Technology transfer provides an opportunity to examine, redesign, or upgrade various components of an organization’s analytical procedures or manufacturing processes. In addition to enabling sponsors and manufacturers to exchange program-critical information with one another, technology transfer is an excellent chance to do so.
According to the guideline ICH Q8(R2), businesses can enhance product quality by considering new techniques at all stages of the product’s lifecycle. For instance, the receiving location can examine a program with a new set of eyes and conclude that a different piece of equipment more suited to the job will make the production process more efficient.
Team Specializing in Technology Transfer.
It is essential that a team responsible for the transfer of technology be made up of cross-functional subject matter experts, and the roles and duties of each team member should be made clear. Personnel from various fields, including research and development, manufacturing, quality assurance, quality control, and regulatory affairs, must be present at the donor and receiving sites.
To have a successful technology transfer and a profitable long-term partnership, which can extend throughout product development and into the commercialization stage, it is essential for the donor and receiving sites to have a close relationship with one another and to communicate effectively with one another.
Documentation and information about the technology transfer process.
To ensure that a successful technology transfer takes place, both the donor and the receiving locations are required to collect and prepare the following documents:
Plan for the transfer of technology:
This details everything that has to be transferred, including the activities, the actions that need to be followed for the transfer, the obligations each group needs to fulfill at each location, and the desired result.
Methodologies analyze détaillées:
One of the first aspects of a manufacturing process that is transmitted is the analytical procedures. In addition, the results of the studies are utilized for comparability assessments, which means that they are also the basis for the success of technology transfer.
The description of the manufacturing process or the batch:
The manufacturing batch record is the essential document there is to have when attempting to describe the production process. It must be clear, detailed, well-written, and properly examined by the donor site for a smooth transition from one manufacturing process to another while maintaining all crucial details appropriately. Because the know-how is not usually thoroughly documented in the batch record, the manufacturing process transfer team should always include a technical specialist from the site donating the manufacturing process.
CPPs, or critical process parameters, include the following:
CPPs should be monitored or managed following ICH Q8(R2) to guarantee that a product possesses the level of quality sought. In most cases, they are detected through an analysis of the degree to which the variation in question could affect the quality of the therapeutic product. For a successful transfer, it is necessary to recognize and consider the CPPs and any other significant criteria.
Critical quality characteristics, also known as CQAs:
According to ICH Q8(R2), an essential quality attribute (CQA) is a physical, chemical, biological, or microbiological feature or characteristic that must fall within an appropriate limit, range, or distribution to guarantee the product meets the quality standards that have been established. During the process of technology transfer, it is essential to have both an understanding of and control over the CQAs of the product.
Technical gap analysis is the formal documentation of an assessment of known and possible gaps between the capabilities of the donor and receiving sites and their preparation for the transfer. This assessment compares the powers of the donor site to those of the receiving site. During the analysis, for instance, it will be determined whether or not the receiving area is equipped with the proper machinery to carry out the manufacturing process or the analytical methods being transferred. A risk assessment should be included in the document.
Adequate change control management system: Any changes or adjustments made to the process or equipment should be documented, reviewed, and justified concerning their possible impact on the Critical Quality Attributes (CQAs) and the Quality Target Product Profile (QTPP).
Transfer of Technology: Carrying It Out and Checking It Over.
A strategy for the transfer of technology should be carried out in stages according to the circumstances, with clear evidence that each step has been finished before moving on to the next level. As an illustration, producing a batch at a smaller scale should be finished with satisfactory results before making an engineering batch at the scale at which the manufacturing batch is scheduled to be produced. The same logical stages should be undertaken for an analytical method transfer, beginning with performing and documenting familiarization runs. This should be done before starting validation runs.
Documentation of a successful transfer of technology is recommended. The receiving site can routinely duplicate the transferred product, process, or method by a predefined set of acceptance criteria. This evidence should be generated concerning the product’s QTPP and CQAs. To conclude, a comparability analysis is typically carried out.
Conclusion
“technology transfer” describes the exchange of intellectual property, technical know-how, and other scientific and technological information between different entities. Here are some rules to follow to guarantee a smooth transfer of technology: First, there must be open lines of communication between technology transfer groups, academics, and other interested parties. The potential for commercialization and the effects of the transferred technology must be well understood by all parties involved.
The transfer of technology should not occur without adequate protection of intellectual property. To successfully get relevant patents, tech transfer agencies must thoroughly assess the technologies they are transferring. Third, do your homework to make sure the technology you’re about to receive is safe, legal, and ethical before you hand it over. Make a pact to share your tech:
The access to, use of, and use of the technology, as well as the protection of intellectual property, are all addressed in detail in a well-drafted transfer agreement. 5. Weigh the Rewards: The economic and other possible benefits of the transferred technology.
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FAQs
What exactly does “technology transfer protocol” entail?
When something like data, designs, inventions, materials, software, technical expertise, or trade secrets is transferred from one organization to another or for a different purpose, this is called technology transfer. Each organization’s policies, procedures, and principles are compass points during the technology transfer process.
What are technology transfer’s responsibilities?
Officers in charge of technology transfer aid in commercializing laboratory discoveries to better people’s daily lives. They oversee the study’s intellectual property and form alliances with other businesses to disseminate the findings to consumers.
What are the rules for transferring knowledge in the pharmaceutical industry?
The World Health Organization defines technological transfer as “The transfer of the manufacturing process for a new pharmaceutical Drug Substance (DS) and Drug Product (DP) from the transferring site (here, R&D) to the receiving site or designated commercial manufacturing site” is how the FDA defines technology transfer (TT).
What prevents the smooth diffusion of technologies?
Institutional and structural barriers; a failure to understand local needs; a lack of information; insufficient human capabilities; political and economic barriers (including a lack of capital, high transaction costs, a failure to price goods and services at a total charge, and barriers to trade and policy); and business-related barriers.
