CAMBRIDGE, MA—Turning candidate cell and gene therapies into commercial products will require innovation in manufacturing, according to Jenna Balestrini, Ph.D., a speaker at the upcoming CAR TCR Summit 2022 conference. Dr. Balestrini, a biomedical engineer and published researcher at Draper, says modular devices, new processing protocols and “technology agnostic” tools will contribute to the large-scale manufacturability of therapies.
Balestrini works in Draper’s Biomedical Solutions group, which provides devices and engineering services to manufacturers of cellular and gene therapy products. She will join the CAR TCR Summit conference as a speaker to discuss why breaking down the walls between discrete processes and accelerating manufacturing can bring us closer to solving complex challenges—including the future of patient care.
“AT CAR TCR Summit, I will address the interplay between technology designed for discrete processes and the desire of biopharmaceutical companies for simplified and scalable manufacturing. Currently, there is a drive toward modularity, especially among companies intending to bring their therapies to market. CAR TCR Summit will give us a chance to discuss a range of use cases,” said Balestrini. Balestrini’s research on cellular therapy manufacturing has appeared in Lab on a Chip and other publications.
Draper, long known as an engineering innovation firm, is expanding its bioprocessing business while pursuing a technology agnostic strategy that emphasizes innovation and flexibility. The company is a leader in the field, having made major contributions such as a microfluidic transduction device, acoustic microfluidic system, an electroporation module and an in-line buffer exchanger to increase efficiency of cell modification.
Today, biomanufacturing platforms make up a growing segment of the market for preclinical drug development. A sticking point for biomanufacturers has been the inability to build a scalable, automated, end-to-end manufacturing process. These pharmaceutical industry challenges highlight the need for a more integrated approach to drug discovery than many bioprocessing platforms can provide. The FDA has identified manufacturing cell therapies at scale as critical to bringing down the cost and increasing availability to patients.
“The way to give more patients access to life-saving therapies is by using a modular, closed, end-to-end bioprocessing system that’s capable of processing billions of cells in hours—enough to produce a treatment in a single, standard work shift,” says Balestrini, Draper’s Head of Strategy for Commercial Bio and Head of Cell Bioprocessing. “Biopharma companies in the process of critically evaluating and selecting cell bioprocessing capabilities for targeted therapeutics development are discovering the benefits of a single platform for bringing their cell and gene therapies from early research and discovery all the way through to commercialization.”
Draper is an engineering and science partner to several biopharmaceutical companies. Among its customers, the company provides technologies to enable the development of therapies to treat cancer and autoimmune diseases, with a primary focus on genetically engineered T cell and exosome-based therapies.
Numerous reports say the cell and gene therapy market is booming, with some estimates projecting revenues to reach $12 billion a year by 2025, up from $1 billion in 2018. Experts say the growth will rely on wider implementation of bioprocessing technologies such as single-use and in-line processing technologies.