Principles of Technology Transfer
Posted by Norm Fong
Feb 25, 2016 1:09:37 PM
In the context of contract drug development and manufacturing, transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacturing sites.” It is the systematic procedure that is followed to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible party.
Because we often have seen this transfer attempted between sites that have limited expertise with the products and limited knowledge as to how to transfer products successfully, we offer this brief guide to some of the key principles.
Transfer of technology involves both the transfer of knowledge and the demonstrated ability of the receiving entity to perform the critical elements of the transfer to the satisfaction of the regulatory bodies.
Among the critical areas that must be considered:
Organization and management of the transfer.
For a technical transfer, many of the activities happen in parallel and simultaneously, while some tasks depend on another task. In order to have a successful technical transfer, there needs to be a person in charge who manages these and ensures that they keep on track.
Skills assessment and training required.
The information gained during development or during the production of the first batches of the product should be shared with the ones taking over the projects. There needs to be training to transfer this knowledge. Does the receiving site have the skills to deal with difficult products?
Assessment of premises and equipment.
An assessment needs to be made to determine if the manufacturer is capable of the proper handling of any potent chemicals or ones that may be flammable or explosive. The equipment also needs to be assessed to ensure it can accommodate the hazards, and also to determine if the equipment is the right size for the product and uses the same type of technology as the original site.
Documentation (specification and other specialized procedures).
These documents need to be forwarded to the receiving site.
Transfer of development and production records in the areas of processing, packaging and cleaning. In many cases, the documents should outline documentation procedures and any special notes or comments.
With the product records, there may be special notes that can be lost when the records are not transferred. Wide limits for parameters exist but the records will narrow down the parameters.
Transfer of analytical methods for quality assurance and quality control.
If these analytical methods have already been developed, they should be transferred to the new site, resulting in shortened timelines.
Site-to Site Technology Transfer
When performing a site-to-site transfer, personnel with the knowledge and experience of the product must be available to assist in the transfer training, guidance and assessment for the internal receiving site.
Documentation with regard to processing, packaging, cleaning validation, analytical methods and associated procedures should be readily available. Many of these documents will not need to be reproduced as they should be already globally acceptable within the company. No external approvals of documents or external technical support would be required, and manufacturing equipment capabilities and capacities should be already known.
Limited documentation with older products may hinder a smooth transfer. Historical experience for the product may not be available as the product to be transferred may be an acquisition of an old product. Also, obtaining that historical information also is dependent on the willingness of the existing site to share.
Older products to be transferred may have utilized outdated technology and may require modification or enhancement to be suitable. In these cases, a comparison of supplemental post-approval changes (SUPAC) would be required, and all documentation must be reproduced and approved by external units.
The Impact of ICH Q10 Guidelines on Technology Transfers
According to ICH Q10 guidelines, “The goal of technology transfer 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.”
To ensure a successful transfer, companies should form a collaborative development team comprising the necessary skills and knowledge to effect the transfer; develop a written control strategy to focus attention on critical points in the process and equipment; review process flow for inputs/outputs that may impact quality; and have a measurement capability in place to track key metrics such as repeatability and precision.
When all the participants play their role appropriately, technology transfer can be simple, straightforward and trouble-free.
Norm is the technical transfer manager, business development, for WellSpring. He has over 21 years in the pharmaceutical manufacturing industry and has held development, transfer and commercial manufacturing positions over the course of his career with Patheon, Global Pharm (formally Pharmacia Upjohn) and Genpharm (owned by Merck). Norm is responsible for overseeing technology transfer and all validation activities in the organization.
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