Defining a Generic Technology Transfer Process for use Across the Biopharmaceutical Manufacturing Industry.

The technology transfer process varies widely between organizations across the biopharmaceutical industry. This variation amplifies the complexity of transfers and negatively impacts the communication of critical information. Organizations tend to either have their own established inflexible processes or unclearly defined processes that change over time. This lack of standardization is compounded as individual companies redefine their processes to meet changing requirements. This creates inefficiencies and barriers to collaboration between organizations due to dissimilar technology transfer processes. Additionally, the industry is evolving rapidly with companies adopting new and novel processes (e.g., continuous processing, new modalities) to meet the global demand for biopharmaceuticals. As the processes become more complex and divergent, the need for a generic technology transfer process increases. This National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) sponsored paper defines a generic technology transfer process using input from a broad range of subject matter experts from across the industry. This generic definition, which is not specific to any one company or any specific implementation, is provided as a starting point for organizations to build on in the future.