Brian Lee, Founder and CEO“Driven by a vision to be the industry's premier solutions provider, our company strives to revolutionize the manufacturing process for allogeneic cell therapies,” says Brian Lee, Founder and CEO of the PBS Biotech.
Through its contemporary technology and expertise, the company enables researchers and manufacturers to scale up their operations efficiently and to overcome the challenges of producing high-quality cell therapies in vast quantities.
Innovative Single-Use Bioreactor Systems
Innovative single-use bioreactor systems are at the core of PBS Biotech's offerings. These systems are meticulously designed to solve the unique challenges inherent to scalable production of human cells. The company's patented Vertical-Wheel® (VW) bioreactor mixing system ensures the optimal hydrodynamic conditions for threedimensional, suspension-based cell cultures. This breakthrough technology allows for the scalable production of various types of human cells, essential for developing allogeneic cell therapies.
The firm’s VW bioreactors generate optimal hydrodynamic conditions for sensitive human cells grown as aggregates or on the surface of microcarriers and maintain these conditions across various volumetric scales. This unique scalability enables small-scale VW bioreactors units to serve as accurate scale-down models for larger models, providing consistent and predictable cell culture performance in terms of yield and quality.
The distinct features of VW bioreactors give it a competitive edge. The unique geometry and vanes of the Vertical-Wheel impeller facilitate radial and axial fluid flow. Paired with the U-shaped single use vessel, these bioreactors achieve complete suspension of particles such as aggregates and microcarriers, which are much larger and heavier than single cells, ensuring gentle mixing while minimizing shear forces and power input to the impeller. These hydrodynamic conditions, characterized by a narrow distribution of energy dissipation rates (EDRs), are ideal for sensitive adherent cells and can be maintained across the entire size range of VW bioreactors.
Addressing Industry Challenges
Currently, allogeneic cell and gene therapy companies face significant challenges in optimizing scalable manufacturing processes for adherent human cells such as PSCs or MSCs.
Adopting the right manufacturing technology early in process development is crucial, as it optimizes cell yield and enhances quality during expansion and differentiation, paving the way for efficient scaling up to commercial production. Furthermore, as clients transition into clinical stage research, they encounter the formidable task of manufacturing exponentially larger quantities of cells compared to the R&D phase.
Embracing a Visionary Path
PBS Biotech provides a comprehensive manufacturing platform and specialized services tailored to address these challenges. By leveraging its innovative solutions, PBS Biotech empowers cell and gene therapy companies to overcome scalability obstacles, enhance cell yield and quality, and achieve efficient and cost-effective production at both clinical and commercial scales.
Comprehensive Cell Culture Development Services
PBS Biotech goes beyond just providing equipment; it offers comprehensive cell culture development services tailored to clients' specific requirements. With a team of experienced bioprocess engineers and scientists, the company collaborates closely with clients to develop scalable and efficient manufacturing processes.
The seamless integration of cutting-edge technology and extensive industry know-how empowers clients to achieve high-quality cell production at any volume. Whether optimizing cell expansion, improving cell yield, or maintaining product quality, PBS Biotech's team can meet each client's unique requirements.
A Stellar Track Record of Achievement
In recent case studies published in reputable journals, VW bioreactors have demonstrated remarkable success by independent agencies not affiliated with PBS Biotech. A 2023 study by Vallabhaneti et al., conducted as part of the CBER group within the FDA and published in Cytotherapy, showcased the successful expansion and differentiation of PSCs as aggregates and microcarriers using small-scale VW bioreactors.
Additionally, a study by Cuesta-Gomez et al. from the University of Alberta, Canada, published in Stem Cell Research and Therapy, highlighted that PSCs grown in VW bioreactors showcased superior expansion, pluripotency, and significantly reduced costs compared to outcomes attained in comparable 2D systems. These findings indicate that PBS Biotech's manufacturing technology offers a scalable manufacturing solution, promising favourable outcomes for large-scale expansion and differentiation processes.
Driven by a vision to establish itself as the industry's premier solution provider, PBS Biotech strives to revolutionize the manufacturing process for allogeneic cell therapies
The company offers a diverse product family, including the PBS Mini, designed for small-scale applications with a maximum working volume of 500 millilitres, and the PBS3, PBS-15, and PBS-80 bioreactors (3-litre, 15-litre, and 80-litre scale, respectively).
The PBS Mini is designed for use in incubators for control of temperature and gases. In contrast, the other bioreactors (PBS-3 and larger) have fully programmable controller systems that allow for precise control over temperature, agitation speed, oxygen, pH levels, and various other cell culture parameters. Operators can be easily trained to use the equipment on the floor or benchtops in the research and development lab. The company is also developing larger bioreactors, potentially up to 500 litres, to cater to the growing demands of customers, especially those in the clinical development stages or commercial production.
Through its cost-effective disposable solutions and expert process development services, PBS Biotech is committed to helping solve cell culture challenges and accelerate their clients’ time to market. With full funding in place, the company is poised to seize the opportunities presented by the rapidly growing cell and gene therapy market and anticipates significant expansion in the near future.
Scaling Cell Therapy from Research to Reliable Manufacturing
Cell therapy development has moved beyond proof-of-concept science into the demands of repeatable manufacturing and clinical delivery. For executives responsible for advancing these programs, the challenge no longer sits solely in demonstrating biological efficacy but in ensuring that therapies can be produced consistently, economically and at scale without introducing new risks at each stage of growth. Many programs falter not because the underlying biology fails, but because the transition from laboratory processes to production environments introduces variability, cost escalation and regulatory friction that were not addressed early enough.
A central tension defines decision-making in this space: early-stage flexibility often conflicts with downstream manufacturability. Processes designed for discovery rarely translate cleanly into compliant, large-scale production systems, forcing costly redesigns and delays. The ability to maintain continuity from early research through clinical and commercial manufacturing becomes a defining advantage. Organizations that anchor development decisions to the end-state requirements tend to avoid re-engineering cycles and preserve both timelines and capital efficiency.
"The right technology and development support help transform promising cell therapies into scalable, commercially viable treatments."
Technology architecture plays a decisive role in this continuity. Conventional bioreactor systems were originally engineered for scenarios where cells produce a therapeutic output rather than being the therapeutic product themselves. This distinction has profound implications. Sensitive, heterogeneous cell populations require controlled environments that preserve viability while enabling uniform growth across scales. Systems that introduce shear stress or inconsistent mixing conditions can compromise both quality and reproducibility, particularly as volumes increase. A platform that maintains predictable hydrodynamic conditions across different scales reduces the risk of variability and supports smoother progression from bench to manufacturing.
Process design and execution must evolve in parallel with technology. Early development decisions often carry hidden consequences that surface only in late-stage production or regulatory review. Building processes that are inherently scalable, supported by structured quality systems and aligned with regulatory expectations helps prevent these downstream liabilities. Consistency is not achieved through isolated optimization efforts but through disciplined integration of equipment, process knowledge and quality oversight from the outset. This approach ensures that reproducibility is embedded rather than retrofitted, while also improving audit readiness and documentation integrity across programs.
"Strong manufacturing processes help turn promising cell therapies into reliable treatments that can reach more patients efficiently and consistently."
Economic viability remains another defining pressure. As allogeneic therapies move toward commercialization, predictable cost structures become as important as scientific validation. Manufacturing processes must deliver repeatability without excessive resource consumption, while maintaining compliance with increasingly stringent regulatory frameworks. The ability to align process design with cost control and operational readiness determines whether promising therapies can reach patients at scale.
PBS Biotech stands out as a partner that addresses these interconnected challenges through an integrated platform and development model. It designs its vertical wheel bioreactor technology specifically for cell-based products, enabling gentle, uniform mixing that protects cell integrity while supporting scalability. By allowing users to operate on a single platform from early research through GMP production, it reduces the need for process re-engineering and preserves continuity across development stages. Its combined offering of equipment and process development services extends beyond tool delivery, providing direct support in media optimization, scale translation and process design to ensure early decisions remain viable in later stages. This integrated approach positions it as a long-term partner capable of guiding therapies from concept to clinical and commercial realization.
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