By Mike Pinaud, Head of GMP Operations
I was incredibly excited to initiate operations at our state-of-the-art, in-house, clinical manufacturing facility in September, the start of a new chapter at Vor Bio.
Our approach with any major company undertaking is to try to embrace the journey as much as the destination, and during this process it was great to work in close collaboration with colleagues across several departments to leverage their knowledge and bring this project to fruition.
Building our own in-house cell and genome manufacturing operation is a major undertaking and it required a great deal of preparation and coordination. We needed to completely re-build the new space creating cleanrooms, process and analytical development labs, quality control labs and associated office space. Additionally, we had to build out all the processes related to good manufacturing practice (GMP) operations, including developing the facility’s standard operating procedures and other regulatory requirements that must be followed to become GMP compliant. We also needed to perform necessary tests to make sure the space and equipment would function as intended.
Caption: Photos from the first engineering runs being performed in September 2022
The facility will be a vital part of our development of potentially transformative engineered hematopoietic stem cells (eHSCs) and chimeric antigen receptor T-cell (CAR-T) therapeutic candidates for patients with blood cancers. A key strategic benefit of the facility is having the flexibility to reduce the time and cost required to manufacture these complex cell therapy clinical candidates. Another benefit is co-locating several of the organization’s departments to create a seamless work stream. This includes greater integration of our internal research, process development, analytical development, manufacturing, and quality control testing capabilities.
An added value for our team now and in the future as our processes grow and improve – is having the ability to observe process improvements in a GMP environment. Throughout the duration of this project our teams put in the work to really understand each of the steps needed to perform the required manufacturing operations while also gaining greater understanding of why each of those steps were needed.
Our value of fellowship during this process was inspiring to see, and the teams were highly motivated.
I credit outstanding teamwork for helping us finish the project on time, especially given the supply challenges that many building projects experienced during the pandemic. To go from a starting point of demolition at the end of summer 2021, to engineering runs thirteen months later was a remarkable accomplishment. We moved quickly without sacrificing quality.
I am incredibly proud of everyone who played a role in making the work both enjoyable and meaningful, as our ultimate vision of developing a potential cure for patients with blood cancers drove us every day.