Tech Transfer: Analysis of Current Challenges and Defining a Generic Model

Generic tech transfer framework streamlines processes, improves data management, and cuts timelines. Further, this framework reduces delays, avoids rework, and supports future digital transformation across biopharma.

Industry Need

The biopharmaceutical industry lacks a harmonized technology transfer process, creating inefficiencies and barriers to collaboration. A generic framework is essential to streamline communication and support evolving, complex manufacturing approaches.

Approach

To address the industry need, the project team collaborated with a broad range of subject matter experts from across the NIIMBL membership to define a generic technology transfer process. This approach ensures the framework is company-agnostic, adaptable, and serves as a foundational model for organizations to build upon as processes evolve.

Impacts

The project will establish harmonized technology transfer templates and terminology to improve collaboration.

This project supports future digitalization and automation of technology transfer platforms.

A generic technology transfer process can be used as a starting point for less mature companies to understand requirements during technology transfers.

Value Statement/Outcomes

Adopting the generic technology transfer framework developed in this project streamlines processes and improves data management, reducing transfer timelines by 10–20% and saving $500,000–$1 million per transfer. By minimizing delays, avoiding redundant work, and enabling future digitalization, organizations will lower costs, accelerate product delivery, and enhance collaboration across the biopharmaceutical industry.

Outputs/Deliverables

Generic technology transfer process diagram and definitions that can be used to streamline transfers between sites and organizations.

Publications

Moore, J., Chinchilla-Olszar, D., Switzer, M., Nellis, D., Lasko, D., de la Fuente Sanz, R., Edmunds, C., Schaeffer, G., Gadberry, A., Earley, J.N., Thimothy, M., and Lee, K.H. (2025). Defining a Generic Technology Transfer Process for use Across the Biopharmaceutical Manufacturing Industry. PDA Journal of Biopharmaceutical Science. https://doi.org/10.5731/pdajpst.2024-003037.1

Presentations

Moore, J.M., Presenter, NIIMBL Next Generation Manufacturing Facility: Automated Tech Transfer, NIIMBL National Meeting, Washington D.C., June 25, 2025.