PBS Biotech, a supplier of single-use bioreactors, recently closed a private, $10M funding round with BroadOak Capital Partners. The cash enables the company to expand and industrialize its portfolio of single-use bioreactor systems and contract process development services, particularly for cell-based therapies (CBTs).
PBS utilizes proprietary Vertical-WheelTM technology, which provides unique mixing and environmental conditions for cell therapy products which, according to the company, are “superior to traditional stirred-tank bioreactors.” In addition, PBS maintains an in-house bioprocess R&D facility to assist customers on scaling CBT projects from research to clinical and commercial phases.
PBS’s scalable single-use bioreactors are designed to support growth and expansion of induced pluripotent stem cells, mesenchymal stem cells, and exosomes.
“Anchorage-dependent therapeutic cells are typically grown in suspension as cell aggregates or on the surface of microcarriers,” explains Brian Lee, CEO at PBS Biotech. Significant variation in the distribution and intensity of a bioreactor’s hydrodynamic conditions negatively affects cell viability and quality during manufacturing processes.
“The Vertical-Wheel bioreactor creates a homogeneous hydrodynamic environment that can be replicated across different volumes,” notes Lee. “This is a critical requirement for developing a truly scalable manufacturing process for allogeneic cell therapies, encompassing benchtop to clinical and eventually commercial production.”
Scaling up manufacturing is arguably the single most significant hurdle to commercializing allogeneic cell therapy products. “What works at small or clinical scale may not translate easily to commercial scale,” Lee says. “That is why developing and optimizing every aspect of a scalable manufacturing process is challenging but necessary to produce cell therapy products reliably, safely, and cost-effectively.”
Single-use manufacturing provides manufacturers of therapeutic proteins with alternatives to stainless steel, with the advantages of versatility, flexibility, and more rapid time-to-market. However, for cell-based therapies single-use may be the best option to achieve scalability with the benefits.
“Due to the unique biological and process requirements of therapeutic cells, single-use bioreactors are the only technology capable of scalable manufacturing and eventual commercialization of cell-based therapies,” Lee tells GEN.