CIO Bulletin

PBS Biotech – A scalable solutions provider specifically catering to the global allogeneic cell therapy market

PBS Biotech, headquartered in Camarillo, CA, USA, has established itself as a key player in the field of cell therapy since its inception in 2006. Specializing in single-use bioreactor systems and offering comprehensive process development services, the company has garnered widespread acclaim for its innovative solutions.

At the heart of PBS Biotech's contributions to the industry is the Vertical-Wheel bioreactor, a groundbreaking technology designed to meet the specific needs of cell therapy manufacturing. Unlike traditional methods, this bioreactor offers scalability, allowing the manufacturing process to be tailored according to different production requirements. This adaptability is crucial in the dynamic landscape of cell therapy, where varying scales of production are often necessary.

One of the significant advantages of the Vertical-Wheel bioreactor is its ability to streamline the process development for clients. This means that companies utilizing PBS Biotech's technology can accelerate their product development cycles, bringing therapies to market more swiftly. This rapid turnaround time is pivotal in the context of emerging treatments, where speed can directly impact patient outcomes.

In essence, PBS Biotech's innovative approach, exemplified by the Vertical-Wheel bioreactor, not only represents a leap forward in technological advancements but also plays a pivotal role in advancing the field of cell therapy. By providing cutting-edge solutions that enhance efficiency, scalability, and quality in the manufacturing process, PBS Biotech contributes significantly to the realization of novel cell-based therapies, offering hope and healing to patients worldwide.

PBS Biotech's R&D Facility

PBS Biotech's Bioprocess Research & Development team is renowned for their expertise in cell culture processes, catering to various therapeutic cell types such as iPSCs and MSCs. Utilizing an advanced onsite laboratory, this team delivers exceptional contract process development services to clients worldwide.

Expertise in Cell Culture: PBS Biotech's Bioprocess Research & Development team is globally recognized for their proficiency in cell culture processes, specializing in therapeutic cell types like iPSCs and MSCs.
Exceptional Contract Process Development: Utilizing their advanced onsite laboratory, the team provides outstanding contract process development services to clients worldwide, ensuring high-quality outcomes.
State-of-the-Art Facility: PBS Biotech operates within a cutting-edge 63,800 sq. ft. facility, equipped with a dedicated cleanroom and manufacturing areas. Here, they assemble single-use vessels and electro-mechanical bioreactors.
Rigorous Quality Standards: All products undergo meticulous in-house assembly and inspection processes, guaranteeing they not only meet but exceed the highest quality standards in therapeutic cell manufacturing.
Substantial Funding: In early 2023, PBS Biotech secured significant funding from leading investors such as Avego Management, LLC, and BroadOak Capital Partners. This funding infusion empowered the company to enhance its product portfolio and strengthen its process development capabilities, enabling global expansion and support for clients.
Global Vision: PBS Biotech aims to become the global standard in manufacturing platforms for allogeneic cell-based therapies. Their mission is to facilitate potential cures for severe conditions like diabetes, cancer, and heart disease, demonstrating a strong commitment to innovation and quality.
Advancing Cell Therapy: With an unwavering dedication to innovation and quality, PBS Biotech continues to drive advancements in the field of cell therapy, offering hope and potential solutions to patients worldwide.

Vertical-Wheel^®: A New Paradigm for Suspension Cultures

Introducing a revolutionary approach to suspension cultures, the Vertical-Wheel^® impeller stands as a groundbreaking innovation, providing an ideal fluid mixing environment for delicate therapeutic cells.

The Vertical-Wheel impeller, operating within a distinctive U-shaped vessel, achieves full suspension and gentle agitation of anchorage-dependent human cells, which are particularly sensitive to a bioreactor's hydrodynamic conditions. One of its critical advantages lies in the ability to consistently replicate cell culture processes and hydrodynamic conditions optimized at a small scale when scaling up to larger volumes.

Key Benefits of Vertical-Wheel Mixing for Therapeutic Cells:

Consistent Morphology of Cell Aggregates:

Ensures uniform morphology of cell aggregates.
Enables complete particle suspension while maintaining a narrow distribution of energy dissipation rates (EDR).
Promotes the formation of circular aggregates with similar diameters, enhancing consistency.

Minimal Shear Stress to Cells on Microcarriers:

Requires minimal power input to the impeller, ensuring consistent fluid flow patterns without the formation of hot zones with high turbulence and shear stress.
Kolmogorov eddy lengths are sufficiently large to prevent shearing effects on surface-attached cells, preserving cell integrity.

True Scalability of Cell Culture Process:

Process parameters optimized at a small scale can be seamlessly recreated at larger volumes.
Predictable results are achieved, offering a truly scalable bioreactor platform that aligns with manufacturing and regulatory requirements.

Homogeneous Mixing Environment:

Facilitates a homogenous mixing environment, crucial for the formation of circular aggregates with consistent diameters.
Ideal for maintaining the delicate balance required for the growth and development of therapeutic cells.

In essence, the Vertical-Wheel impeller represents a paradigm shift in suspension cultures, offering a reliable and scalable solution for the cultivation of sensitive therapeutic cells. This innovative technology not only ensures the integrity of cells during the cultivation process but also simplifies the transition from small-scale optimization to large-scale production, providing a game-changing solution for the biopharmaceutical industry.

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Prduct Development: Ensure Your Best Possible Process

Ensure the excellence of your cell culture process with the expertise of their dedicated BioLab team, committed to tailoring scalable solutions precisely to your product and specifications.

Maximizing Yield and Quality: Benefit from the proficiency of PBS Biotech's scientists and chemical engineers, renowned for their industry-leading skills in developing cell culture procedures for a wide array of therapeutic cells. They specialize in creating scalable processes designed for seamless tech transfer. Their clients have achieved significant milestones, including successfully scaling up Pluripotent Stem Cell (PSC) cultures, enabling smooth progression into crucial first-in-human trials.

PBS Biotech stands as a beacon of proficiency and innovation. The company’s team of esteemed scientists and chemical engineers are renowned throughout the industry for their unparalleled skills in developing highly efficient and scalable processes for therapeutic cells. Their expertise extends across various cell types, enabling seamless tech transfer and propelling clients toward significant milestones, including successful progression into vital first-in-human trials.

Unraveling the Expertise: Within the walls of PBS Biotech, a dedicated team of scientists and chemical engineers diligently delve into the complexities of cell biology. Armed with extensive knowledge and experience, they craft customized cell culture procedures tailored to specific therapeutic cell types. Their precision enhances cell growth, viability, and productivity, ensuring clients receive the highest quality results.

Seamless Transition to Scale: One of PBS Biotech’s key strengths lies in its ability to develop scalable processes. These meticulously crafted protocols effortlessly transition from laboratory-scale research to large-scale production. This scalability is pivotal, allowing clients to seamlessly expand their projects without compromising quality. By maintaining consistency throughout the scaling process, PBS Biotech enables researchers to advance their studies efficiently and effectively.

Empowering First-in-Human Trials: Under the guidance of PBS Biotech’s experts, clients achieve remarkable progress. Notably, the team has played a crucial role in scaling up Pluripotent Stem Cell (PSC) cultures, a pivotal step toward successful first-in-human trials. This achievement ensures that therapeutic cells are produced at the required scale and quality, propelling these groundbreaking treatments from the lab to the clinic.

Tailored Support and Collaborative Endeavors: Recognizing the uniqueness of each research project, PBS Biotech offers comprehensive, tailored support to its clients. The company fosters collaborative partnerships, working closely with researchers to understand their specific goals and challenges. This collaborative approach enables PBS Biotech to provide personalized solutions, ensuring that clients receive the precise support they need to achieve exceptional results.

Process Development Capabilities

Their BioLab team brings extensive expertise to the table, particularly in scalable cell culture processes involving diverse cell types. Whether its PSCs grown as aggregates, Mesenchymal Stem Cells (MSCs) cultivated on microcarriers, or the meticulous handling of Chimeric Antigen Receptor-T (CAR-T) or Natural Killer (NK) single cells, they have the know-how. Within the state-of-the-art 2,940 square feet research laboratory, their dedicated scientists employ innovative techniques to develop and scale up processes tailored to your specific cell lines. Their capabilities encompass:

Seed Expansion and Passaging:

Expert handling of working cell banks.
Serial passaging techniques ensuring the vitality of your cells.

Aggregate-Based Processes:

Comprehensive management of processes including seeding, expansion, differentiation, dissociation, and harvesting of cell aggregates.

Microcarrier-Based Processes:

Proficient handling of seeding, expansion, detachment, and harvesting for cells grown on microcarriers.

Rapid Medium Exchange Techniques:

Innovative methods for swift and efficient medium exchange to support optimal cell growth and health.

Cell Separation, Washing, and Concentration:

Specialized techniques for precise cell separation, thorough washing, and concentration, ensuring the purity and viability of your cell cultures.

At PBS Biotech, they are not just developing processes; they are crafting tailored solutions that optimize yield, quality, and efficiency for your unique cell therapy products. Trust BioLab team to propel your research and development efforts forward, enabling breakthroughs in the field of cell-based therapies.

Brian Lee, Ph.D. | Founder and CEO

Dr. Lee has over 25 years of research, management, and leadership experience in biopharmaceutical R&D, bioprocess scale up, and biomanufacturing with Amgen and Merck.