Navigating The Allogeneic Commercialization Journey: The Challenges And Triumphs

The journey towards preparing a GMP facility for an allogeneic cell therapy product’s commercialization began with the construction of our cell therapy facility in Thousand Oaks, CA. This endeavor was far from straightforward, marked by many twists, turns and challenges along the way, from the unforeseen global COVID-19 pandemic, to introducing pre-IND programs, to the acquisition by FUJIFILM Diosynth Biotechnologies (FDB) to become a CDMO.

At every step of this journey, our dedicated team contributed fresh ideas and innovative solutions. Each challenge we faced became an opportunity for growth, and each success fueled our unwavering commitment to advance our customers' programs for the benefit of patients.

In this article, we walk through the journey and highlight the pivotal moments, challenges, triumphs, and lessons learned that have shaped our evolution from facility construction to a fully operational, patient focused CDMO.