Thomas Jefferson University to Expand Jefferson Institute for Bioprocessing (JIB) Facilities & Offer Early Phase cGMP Clinical Production with Cell and Gene Therapy Focus
The Jefferson Institute for Bioprocessing (JIB) has undertaken a facility expansion program that will empower pilot-scale production of early phase clinical cell and gene therapy material for clients at its Lower Gwynedd (Montgomery County) facility.
By increasing production area to include four additional clean room suites, this milestone effort is expected to see cGMP production capacity active by early summer 2023. With a focus on cell and gene therapy and expanded analytical capabilities, the project aligns with clients’ needs.
The expansion will provide Current Good Manufacturing Practices (cGMP) capabilities, which will allow for phase I/II clinical production.
Parviz Shamlou, PhD, JIB Vice President and Executive Director, said the project is a milestone for the Institute.
“This will allow JIB to serve clients from pre-clinical process development and process optimization through scale-up and early clinical production,” says Shamlou.
Aldo Romano, JIB’s Chief Business Officer, notes that “a six-month runway is what many clients need, so we are delighted to make this announcement now in readiness to meet the needs of our clients.”
Kathy Gallagher, Executive Vice President and Chief Operating Officer, notes the importance of the expansion at JIB’s facility – located in Building 6 at the Springhouse Innovation Park Campus – when coupled with the Institute’s already present training and contract services.
“This will help further position Jefferson to meet the demands in the rapidly accelerating field of biomanufacturing, which is coming to be known as the American Bioeconomy for the 21st century and beyond,” says Gallagher.
JIB already offers process and analytical development services to the cell and gene therapy (CGT) market through its existing facility. The focus is on the processes and science associated with bringing new and advanced therapy medicinal products (ATMP) to market faster.
The rapid and growing interest in cell and gene therapies is a new approach to manufacturing and the expansion will be used to help the ATMP industry needing process development and material supply for phase I/II clinical trials.
Thomas Jefferson University has some of the best-in-class hospitals and researchers working on next generation therapies and the new expansion will empower their research.
The new expansion area is designed with suites capable of cGMP production of cell therapies, gene therapies, viral vectors and plasmid DNA. It will also include expanded analytical and quality control service areas to support internal programs as well as for external client contract work.
JIB has significant subject matter expertise in these areas and already provides IND enabling, platform development, consulting, and training services to industry clients in immunotherapy, stem cell therapy, and gene therapy.
“Through JIB, we have invested in infrastructure, people, and resources to help build future workforce development and provide process development to researchers and industry partners,” Gallagher says. “The University’s investment in ATMP is strong.”