Defining the steps involved in a successful technology transfer process would benefit biopharma, say the researchers behind a “generic” blueprint intended to help drug makers move more easily from pilot plant to commercial facility or third-party contractor.

The study, which was sponsored by the U.S. National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), looked at ways of minimizing errors during technology transfer and found that the lack of a standard methodology is a major problem.

“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,” they add.

Generic tech transfer

To try and overcome this, the authors developed a generic reference process based on input from nine organizations across the biopharmaceutical manufacturing industry and academia.

“This generic technology transfer process definition is designed to meet the requirements of organizations within the biopharmaceutical manufacturing space and ensures the individual elements are not specific to any one contributing organization.”

The initial aim is to provide industry with a starting point, according to the authors, who say the long-term goal is to simplify communication between organizations and enable the eventual automation of the tech transfer process.

The process defines the sending site and the receiving site as the key functional groups, assigning each team key responsibilities.

For example, the sending site must ensure that the process and analytical methods required to manufacture a product are given to the receiving site. Additionally, they must also evaluate whether updates can be made to the process in the event of a mismatch between the receiving site capabilities and the process.

The receiving site, in contrast, should take responsibility for understanding the communicated process and comparing it to internal capabilities and updating the equipment, raw materials, clean rooms, utilities, documentation, and automation at the manufacturing site as needed.

The process also outlines an information management structure, designed to facilitate the streamlined transfer of information irrespective of the number of production sites involved.

“Regardless of whether a transfer involves a single site or multiple sites, it is best practice to always have one group managing the requirements of the process and another group managing the abilities of the manufacturing facility. This flow of knowledge through a formal technology transfer channel to manufacturing and related support groups is what constitutes the backbone of the overall technology transfer process,” the authors write.