The Power Of The Pool: Using Bulk Cultures For Clinical Trial Manufacturing

Traditionally, biopharmaceutical development relies on isolating a single, high-performing cell (clone) from a large pool, a process that can be time-consuming and inefficient. However, recent advancements in transposase-mediated gene integration technologies offer a faster alternative in improved stable bulk cultures.

Companies like ATUM Bio have developed robust processes for generating stable bulk cultures within a month. These cultures can be used for various purposes, including construct screening, process development, and even early clinical trial manufacturing. The potential benefit is significant: using stable bulk cultures could potentially shorten the development timeline for a new drug from one year to under six months.

Regulatory bodies have already set the precedent for using bulk cultures in Phase 1 clinical trials. However, wider adoption will require further development and buy-in from the biopharmaceutical industry. Bulk cultures need to be demonstrably scalable and produce high-quality product that is consistent with what will be ultimately manufactured for commercial use.

ATUM's Leap-In Transposase® platform is a promising technology that addresses these challenges by enabling the generation of stable and robust bulk cultures, leading to a more efficient and lower-risk development process. This technology has the potential to be broadly applicable across various modalities in biopharmaceutical development.