How to Tackle Tech Transfer Projects for Biopharmaceuticals
The transfer of manufacturing processes and analytical procedures between facilities or laboratories is an essential technical activity during the lifecycle of a drug, as outlined in ICH Q10. These “technology transfers” - or simply “tech transfers” - take the outputs of process and method development activities and transfer the knowledge (sending unit) to a different location where the process or analytical procedure should be operated in the future (receiving unit).
Technology transfers require substantial resources, technical know-how and organizational skills in both sending und receiving units. Each tech transfer project has its unique risks and challenges inherent to the product and technology as well as related to the project organization.
TECH TRANSFERS ARE ESSENTIAL FOR PRODUCT DEVELOPMENT AND COMMERCIALIZATION
Technology transfers are frequently conducted throughout the product lifecycle for all types of biopharmaceuticals and can be triggered by a variety of reasons taking into account business and regulatory rationales:
Product life cycle management from R&D through scale-up to routine manufacturing
Post-approval changes to implement new process versions
Need for additional manufacturing capacity driven by increased demand or risk mitigation
Strategic requirements to relocate manufacturing sites for rationalization or economic advantages in different regions of the world
THE TECH TRANSFER PROCESS IN 5 STEPS
The technology transfer process typically consists of 5 main steps which are further outlined in Exhibit 1:
Assessment of the feasibility for the tech transfer project
The technical preparation of the technology transfer for analytical methods and manufacturing process
Implementation of analytical methods and manufacturing process up to technical batch scale at the receiving unit
Compilation of comprehensive documentation of the tech transfer
Obtain approval by regulatory authorities
Certain tech transfer activities may run in parallel, and cross-functional collaboration is required during each process step. Investing sufficient time and resources initially for planning of the tech transfer project will pay off at subsequent project stages. This includes a well prepared transfer plan, tech transfer package as well as a gap and risk analysis in the beginning of the project.
EXHIBIT 1 | The technology transfer process explained in 5 steps.
EXPECT RISKS, GAPS AND CHALLENGES
Technology transfers are complex projects, and each step of the tech transfer process requires consideration to address the project specific risks. These risks can be categorized into two main groups
Technical and development risks
Project management and organizational risks
A selection of risks and challenges commonly encountered during tech transfer projects are summarized in Exhibit 2. Of note, there are always technical risks or gaps specific to the project and technology which are typically identified and mitigated during an initial high-level risk and gap analysis.
For example, the exact production equipment of the sending unit may not always be available at the receiving manufacturing site, which likely requires adjustments to the manufacturing process when transferring it to the receiving unit. Consequently, the manufacturing process must be optimized for the available equipment at the receiving unit to maximize product yield and to minimize impurity levels.
EXHIBIT 2 | Examples of commonly encountered tech transfer risks, which in sum can have a huge impact on the project.
Most of the tech transfer risks may be categorized as moderate risks. However, in sum, they can have a huge impact on the quality, timelines, costs and resource needs of the tech transfer. Companies that successfully manage tech transfers continuously analyze and reduce the risks to an acceptable level throughout the technology transfer process.
We can support your technology transfer projects.
Comprehensive project management and targeted support of the transfer team
Development of integrated technology transfer plans and strategies
Compilation of technology transfer packages and document preparation for regulatory submission
Creation of customized and streamlined processes and operating procedures for technology transfers in your organization