Bioreactor Scale-Up

Amplifying Therapies with Bioreactor Scalability

Unlocking the Potential of Bioreactor Scale-Up for Advanced Therapies

At Cytohub, we are at the forefront of innovation in the field of cell and gene therapy, empowering the future of personalized medicine. Our expertise lies in the development and commercialization of cutting-edge products, with a particular focus on NK cell Car-T and HSPC therapies. As part of our commitment to delivering groundbreaking treatments to patients, we recognize the critical importance of bioreactor scale-up in the manufacturing process.

Pre-Clinical Studies: Unleashing the Therapeutic Potential

Before bringing novel therapies to the clinic, it is essential to conduct comprehensive pre-clinical studies. Cytohub specializes in the therapeutic discovery phase and protocol optimization phase, laying the groundwork for safe and effective treatments. Through rigorous experimentation and data-driven analysis, we refine protocols and maximize therapeutic efficacy. Our aim is to ensure that every product we develop undergoes meticulous scrutiny, guaranteeing the highest standards of quality.

Process Development and Scale-Up: Overcoming Bottlenecks

The journey from discovery to commercialization presents numerous challenges, particularly in the area of process development, scale-up, and CMC (Chemistry, Manufacturing, and Controls). Cytohub understands that these stages can be major bottlenecks in the delivery path to the clinic. We have made it our mission to navigate these obstacles efficiently, paving the way for accelerated development timelines and streamlined manufacturing processes.

Optimization of Cultural Protocols: Transforming iPSC Lines and Thaw MCB

Cytohub boasts a diverse portfolio of multiple iPSC lines, serving as a versatile resource for therapeutic development. Our expertise extends to the optimization of cultural protocols in adherent format, as well as the development of 3D suspension culture-based models for technical evaluation of platforms. We are committed to achieving the highest success criteria, including proliferative capacity in suspension culture, depending on cell concentration, and ensuring the average aggregate size distribution of the suspension falls within a narrow range. Additionally, we prioritize the maintenance of high percentages of Oct4, Nanog+, and Sox2+ markers, karyotypic stability, and exceptional cell viability. Our rigorous quality control measures ensure that no mycoplasma or other contamination is present in our products.

Addressing Commercialization Challenges: Next-Level Bioreactor Scale-Up

We have incorporated various critical milestones to optimize production scalability and maximize efficiency. Thaw MCB (Master Cell Bank): Cytohub optimizes the cultural protocol in adherent format and develops a 3D suspension culture-based model to evaluate technical platforms.