Editor’s note: A version of this article originally appeared on the Frederick National Laboratory for Cancer Research website. Mention of trade names, commercial products, or organizations does not imply endorsement by the U.S. government.
The recent Biotech Connector showcased exciting advancements in gene and cell therapies in the Frederick area. More than 80 attendees gathered in-person and online to hear experts in the field discuss their work manufacturing difficult therapies for clinical trials, reimagining the supply chain to reduce development timelines, and leveraging automation to reduce risk and save money.
By capturing these advances, the Biotech Connector aims to serve as a forum that inspires partnerships and the sharing of ideas. New technologies and methods, spurred on by collaboration, can help scientists rethink traditional approaches and enhance human health in new ways.
Cancer Therapies
Vinay Vyas, Ph.D., associate director of the Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research, presented ongoing efforts to develop chimeric antigen receptor T cell (CAR-T) and T cell receptor T cell (TCR-T) cancer therapies.
CAR-T cell therapies are a relatively new approach for treating cancer, with seven receiving Food and Drug Administration approval in recent years. The therapies genetically modify a patient’s own T cells, a type of immune system cell, to develop chimeric antigen receptors that allow them to target and destroy cancer cells. TCR-T cell therapies harness the power of these T cell receptors, proteins on the T cells’ surface, to recognize cancer cells.
Manufacturing these therapies requires extensive expertise and resources. Many hospitals don’t have the facilities to do it. The BDP took on the task at the National Cancer Institute’s request because it has the space, knowledge, procedures, and access to technology to manufacture CAR-T therapy in a scalable, standardized way.
“We work like a boutique biopharmaceutical company,” Vyas said of the BDP. “We have our own quality control. We have our own quality assurance. We have a manufacturing unit and a process development unit.”
As a result, the BDP can turn the blood cells collected from the patient into a usable CAR-T therapy in about three weeks.
Vyas discussed 13 of the BDP’s CAR-T/TCR-T projects, several of which are supporting ongoing clinical studies at the National Institutes of Health Clinical Center. For the first effort, which launched in 2018, the BDP used an externally developed viral vector, but since then, the BDP has developed its own lentiviral and retroviral vectors. Viral vectors are modified viruses that deliver the genetic alteration to the T cells.
“The engine of CAR-T is typically a viral vector,” Vyas said.
Scaling Manufacturing and Supply Chain
Jon A. Rowley, Ph.D., founder and chief product officer of RoosterBio Inc., focused on how to make cell and gene therapy technologies scalable, efficient, and reproducible. RoosterBio manufactures key reagents, tools, and processes that reduce the cost and risk that companies would otherwise need to take on as part of making new drugs and treatments.
“We started RoosterBio really to reimagine a highly fragmented supply chain in cell gene therapy,” he said.
His talk also covered mesenchymal stromal cells (MSCs), which are stem cells that can differentiate into a variety of cell types, including bone, cartilage, muscle, and fat cells.
“MSCs are really a workhorse of regenerative medicine,” Rowley said.
He explained how good manufacturing practice (GMP) plug-and-play bioprocess platforms, such as those created by RoosterBio, are enabling rapid translation of MSC product concepts from idea to clinic, shortening the overline development timeline and reducing costs.
The typical timeline to get advanced therapy products to first-in-human testing is roughly seven to 11 years. However, he said that using a scalable GMP MSC platform could shorten the timeline to two to four years.
Automation of Manufacturing Processes
Manufacturing cell and gene therapies requires multiple steps, and manually handling and transferring between steps and devices can increase the risk of errors and drive up costs.
Brian Paszkiet, principal clinical specialist at Miltenyi Biotec, presented on how automation can reduce these risks and improve efficiency, consistency, and scalability of cell and gene therapy processes. He focused on the CliniMACS Prodigy®, which offers end-to-end automation.
“It automates everything from the beginning to the end of the process, starting with a leukapheresis product or a blood product; washing it; labeling it with the magnetic beads; isolating the different fractions of cells; also enabling activation, transduction, and cell culture; and then final harvest and formulation,” Paszkiet said.
He said the automated plug-and-play platform can be used for a variety of cell types, including CAR-T cells, natural killer cells, and engineered hematopoietic stem cells, and it comes with pre-installed standard manufacturing processes. It’s customizable and, importantly, closed and controlled, which substantially reduces the chance of contaminating the final cell product.
“I could train your kid how to do it … it’s really engineered in a way that makes it very easy to install, and it’s all guided on the screen,” he said.
In fact, the BDP at Frederick National Laboratory for Cancer Research uses Miltenyi’s CliniMACS Prodigy to manufacture CAR-T cell therapies.
Join Us in February
The Frederick National Laboratory for Cancer Research and the Frederick County Chamber of Commerce organize the quarterly Biotech Connector Speaker Series. This event provides an inside look at local advances in Frederick County and the surrounding areas’ biotech and bioscience community. Save the date for our next event on Thursday, February 19, 2026, which will cover AI-powered and computer-driven drug development.
Victoria Brun is a partnership project manager in the Frederick National Laboratory for Cancer Research Center for Innovation and Strategic Partnerships, where she provides project management support across the office’s broad portfolio of collaborative projects. Among its functions, CISP establishes the partnerships and collaborations among Frederick National Laboratory for Cancer Research scientists and external researchers in government, academia, industry, and the nonprofit research sector.