Cell Line Development services

Cell line development is a critical step in the production of biologics, such as monoclonal antibodies and recombinant proteins. This process establishes a stable cell line capable of efficiently expressing the target protein, requiring expertise in cell biology, molecular biology, and process development to optimize stability and productivity. Leveraging advanced technologies and years of experience, we develop cell lines that meet stringent manufacturing requirements. Rodon has extensive experience in microbial (E. coli, yeast) and mammalian (CHO) cell expression systems. Our proprietary and in-licensed technologies allow rapid protein testing across constructs, identifying the most suitable system using tightly regulated inducible promoters for microbial expression and CHO platforms for mammalian expression.

Cell Line Development Process

The development process consists of key stages: gene introduction, cell selection and expansion, optimization of culture conditions, and thorough characterization. After gene introduction, cells are selected and expanded to establish stable, high-expressing clones. Culture conditions and media are optimized to enhance protein yield, followed by rigorous analysis of genetic stability, expression levels, and glycosylation patterns to ensure quality and performance standards. By meticulously executing each phase, our process ensures the development of stable, high-producing cell lines. Our expertise and integration of cutting-edge technologies enable cost-effective and efficient biologics production while minimizing risks.

Microbial Cell Line Development

Microbial expression systems, including bacteria like E. coli and yeasts such as S. cerevisiae and P. pastoris, are extensively utilized for recombinant protein and enzyme production. With Rodon Biologics' extensive experience and expertise in microbial cell line development, genetic engineering combined with optimized culture conditions allows for high titers and rapid growth rates, making these systems ideal for large-scale manufacturing.

Our microbial cell line development services include:

• Plasmid construction with the gene of interest

• Cell transformation with antibiotic selection

• Establish research cell banks (RCB) and study their stability (up to 60 generations)

• Execute and develop thorough analytics and specific assay development support

The development process is meticulously designed to ensure microbial cells, produce high-quality, stable proteins suitable for both research and commercial applications. With deep expertise in microbial cell line development, we support our partners in achieving their project goals, minimizing risks, and optimizing production costs.

Mammalian Cell Line Development

Mammalian cell line development, particularly CHO cell line development, is based on a streamlined workflow that facilitates the generation of high-producing single-cell clones within 16-20 weeks. CHO cell lines, known for their robustness and ability to produce complex biologics, are a preferred choice in the industry. Once a high-producing pool is selected, material quality is evaluated, enabling gram-per-liter production within 9-12 weeks.

Genetic stability and expression levels are assessed for up to 60 generations, ensuring long-term productivity. This ensures that the cell line remains reliable and productive over extended periods, which is crucial for consistent and cost-effective biologic manufacturing.

Our mammalian cell line development services include:

• Plasmid construction with the gene of interest

• Cell transfection with selection

• Pool selection and amplification (cell banking)

• Establish clonal CHO cell lines with documented evidence of clonality

• Establish research cell banks (RCB) and study their stability (up to 60 generations without selection)

• Execute and develop thorough analytics and specific assay development support

Cell Line Stability and Productivity

Ensuring the stability of cell lines is fundamental in biologics production, as it directly affects the consistency and quality of the final product. Our cell line stability assessments are meticulously designed to rigorously evaluate and preserve the genetic integrity and productivity of cell lines over extended periods. Through comprehensive testing, we assess genetic stability, expression levels, and critical post-translational modifications.

Our services include long-term stability studies, where cell lines are monitored across multiple generations to confirm their robustness and productivity. We also deliver detailed analytics to detect potential issues early in the development process, enabling timely interventions. By optimizing culture conditions and refining genetic constructs, we enhance the overall stability and productivity of cell lines, ensuring reliable and cost-effective biologic manufacturing.

Process development services

This stability and productivity can be further enhanced by integrating cell line development with process development. By aligning these two critical stages, we can create a more cohesive and efficient production pipeline. This integration allows for the simultaneous optimization of cell culture conditions and process parameters, leading to improved yields and reduced production costs. Additionally, the collaborative approach ensures that any issues are identified and addressed early in the development process, minimizing risks and accelerating the path to commercialization. This combination of cell line and process development is essential for achieving high-quality, scalable, and robust biologic manufacturing.

RCB Transfer to CMO for MCB Manufacturing

The transfer of a Research Cell Bank (RCB) to a Contract Manufacturing Organization (CMO) is a crucial step in the progression towards Master Cell Bank (MCB) manufacturing. With Rodon's long-standing experience in process development and RCB transfer, we ensure a seamless transition. This process involves the careful selection of a CMO partner, whether through an established partnership or a new collaboration, to ensure alignment with the project's goals and regulatory standards. During the transfer, detailed documentation and communication are critical to maintain the integrity and viability of the cell lines. The CMO then undertakes the task of scaling up the RCB under stringent conditions to develop a robust MCB, which serves as the foundation for large-scale biologics production.

Choosing Rodon for your cell line development needs ensures access to extensive expertise, advanced technologies, and a collaborative approach, all of which optimize production costs, minimize risks, and accelerate your path to successful commercialization.