How Efficient Batch Records Serve Thorough Tech Transfer — Optimizing Aseptic Fill For Development Projects

By Andrew Besherwor, Singota Solutions

Technology transfer — the process of moving drug manufacture from one line or site to another, usually to facilitate a scale-up in production or transferring manufacturing facilities — occurs several times throughout the development process. Each tech transfer demands meticulous attention to detail, including the equipment used, methodologies, and raw materials. Still, this dynamic process can be hampered by employing strategies that fail to optimize timelines and risk loss of knowledge.

Efficient, thorough, and timely tech transfer can benefit from a streamlined batch record process, one that prioritizes populating batch records with the necessary information to reduce drafting time and ensure consistent operation. Too often, though, tech transfers are held up by a missing piece of non-critical (for the current step) information, and the CMO’s processes are not designed to push ahead despite critical information being in place.

Such strategies fail to acknowledge that, while nearly all tech transfers follow a similar path, each sponsor encounters its own challenges. Sometimes, different equipment will be used to accommodate scale-up. Other times, a formulation that worked in the laboratory must be modified to perform as expected at production scale. In many cases, sponsors simply are unprepared to manage the sheer volume of documentation associated with a technical transfer. Most of their experience and data is in R&D, rather than cGMP production and its accompanying regulatory burden.