Successful tech transfer requires recognition of the complexity of the process, effective gap analyses, a focus on product profiles, open and transparent communication, collaboration and strong project management.
The Tech Transfer Challenge
Moving a drug product manufacturing process is a daunting and high-risk task. It is a complicated process in which detailed attention must be paid to all of the necessary elements. If proper planning and management are not executed, the implications of an unsuccessful move can have serious and lasting consequences. For aseptic manufacturing processes, technical transfer is very much like the introduction of a new product and process to a new manufacturing facility.
Importance of Proper Preparation
Due to the complexity of tech transfer projects, success is directly correlated with proper planning and preparation. To enable that any potential issues can be effectively addressed, it is essential to perform a combination of gap and risk analyses between the existing process at the sending site and the envisioned process at the receiving site. The manufacturing and testing steps, organizational issues and logistics should be evaluated to identify the risks posed by differences between the transfer sites.
To be most effective, it is important to follow the requirements of ICH Q8(R2) for Pharmaceutical Development. The results of a thorough evaluation of the quality target product profile (QTPP) of the product and the associated critical quality attributes (CQAs) can be used to define the scope of the transfer.
Trust and Open Communication Are Critical
The complexity of tech transfer projects also creates a significant need for trust and open communication. It is important to involve the individuals that actually make and test the product, since they possess essential personal knowledge and experience.
Successful process transfers are treated as projects with dedicated cross-departmental teams including development, manufacturing operations, quality assurance and quality control, qualification/validation and regulatory affairs, and production planning and logistics. This team is organized and coordinated by a project manager who reports to the project sponsor.
Strong project management is paramount to enable the smooth transfer of a robust process. The roles and responsibilities for all team members must be agreed upon at the start of the project, and a system must be established that enables adequate communication and feedback of information. All functions from both sites should interact with their respective partners in the other organization to enable direct communication between subject experts.
Open communication is also important in dealing with any differences (technical, procedural, regulatory, cultural) between the sending and receiving sites. Transfers between a sponsor company and contract manufacturer may be challenged by all types of differences, while internal transfers may not experience technical differences but may have to manage procedural and/or cultural disparities. Such differences may create underlying resistance to process transfers, particularly from the sending site.
Effective Process Evaluation Is Essential
All manufacturing processes should be evaluated from start to finish. For aseptic fill-finish processes, unit operations include compounding, sterile filtration, filling, visual inspection and secondary packaging. Evaluation of analytical methods that need to be transferred is equally important. In-process testing, release testing, stability testing and other procedures are generally transferred along with the production process, which will require specific analytical capabilities at the receiving site.
The inception of any process transfer is, therefore, the process qualification campaign. This campaign should be based on the FDA’s approach, which involves process design followed by process qualification, with continuous process verification pursued once the transfer is complete. The intent is to achieve a robust, reproducible manufacturing process with consistent quality at the receiving site.
It is also important to recognize that transfer presents the opportunity to redesign and modernize elements of the process to achieve improvements in yield, productivity, efficiency and other metrics.
Key Success Factors
One of the most important factors for success in tech transfer is recognizing that it is a complex undertaking, even for the simplest manufacturing processes. It is also essential to expect the unexpected; even with the best preparation, unforeseen challenges can arise. Collaboration and open communication are the keys to solving such problems.