Cell Line Development for Therapeutic Proteins & Peptides

Cell line development is the foundation of process development and determines the final product quality. CD Formulation has comprehensive cell line development capabilities and expertise, covering DNA and vector construction, top clone selection, research and master cell banks, and stability studies. We provide high-quality cell line development services for many types of protein and peptide therapeutics. Our extensive experience in a wide range of mammalian cell lines, expression platforms, biomolecules, and scales allows us to customize solutions for therapeutic protein production and flexibility.

The Importance of Cell Line Development for Process Development

Stable cell line development is a key step in the biopharmaceutical manufacturing process. It involves selecting and generating cell lines that produce the desired therapeutic protein or antibody. By constructing and screening cell lines, cell lines that meet specific production requirements can be selected to improve production efficiency and product quality. In addition, cell line development can also help companies reduce production costs, shorten production cycles, and increase production scale, thereby optimizing and upgrading production processes and promoting the sustainable development of companies.

Fig. 1. Schematic representation of a state of cell line development process designed for the generation of high-producing CHO manufacturing cell lines.(Castan A, et al., 2018)

Explore Our Cell Line Development Services for Therapeutic Proteins & Peptides

With decades of experience in developing stable cell lines to support biopharmaceutical production, CD Formulation has established a first-class cell line development platform. We provide a wide range of cell line development services for the manufacture of therapeutic proteins and peptides, and develop, validate, and test analytical methods in-house.

The deep expertise of our scientists in process development, media screening, master cell banks, scale-up, and GMP clinical and commercial drug substance manufacturing allows us to provide customers with customized cell line development solutions to meet their specific requirements and goals.

Our cell line development services include:

• Cell line screening and media optimization based on customer needs.
• Establish, characterize, and validate stable production cell lines.
• Scale up and cryopreserve cell lines.
• Develop and optimize production processes to improve product yield and quality.
• Perform GMP manufacturing and provide related analytical services.

What Cell Line Development Services Do We Offer?

We offer comprehensive mammalian cell lines, recombinant stable cell lines, overexpression cell lines, and reporter cell line development capabilities for a wide range of protein and peptide therapeutics, both as stand-alone services and as part of our comprehensive process development services. Our expertise covers a wide range of commercial cell lines and cGMP cell banks.

CHO Stable Cell Line Development

Mammalian cells are the main host cells used to produce commercial therapeutic protein products. Chinese hamster ovary (CHO) cells are the preferred host cells for the production of protein drugs. Using our first-class CHO development platform, our scientists can customize the development of stable CHO cell lines according to your needs, including gene cloning, cell culture, screening, and characterization.

Recombinant Stable Cell Line Development

Recombinant stable cell lines usually achieve long-term stable expression of target genes through transfection or viral transduction vectors, which contain GOI expression elements and selection markers (antibiotics or fluorescent proteins). Compared with transient expression, recombinant stable cell lines provide reproducible results for experimental studies.

Our recombinant stable cell line development includes constitutive cell line development and inducible expression cell line development.

Overexpression Cell Line Development

The development of overexpression cell lines first involves introducing exogenous genes into host cells, followed by screening through resistance genes, and finally identifying cell lines that continuously overexpress the target gene.

We have extensive experience in the construction of overexpression stable cell lines and efficiently provide customers with a variety of cell line services that stably express specific genes, while also meeting your personalized customization services for the preparation of multiple markers.

Reporter Gene Cell Line Development

Reporter gene cell lines are used to establish the correlation between target transduction signals and reporter gene expression in cells through genetic engineering methods, thereby constructing a drug target-specific model cell line. These gene cell lines are usually screened and improved to ensure that they produce high-quality and large amounts of protein.

Our scientists carefully design and develop specific cell lines based on your project needs, including selecting appropriate reporter genes, constructing transduction proteins, and optimizing cell growth conditions.

Cell Line Development Process

Fig. 2 Cell line development process for protein drugs. (CD Formulation)

• Transfection: The process of introducing foreign DNA into host cells. A small population of cells that carry foreign DNA inserted into their genome and can maintain their ability to express protein for a long time is called a stable cell. This is usually done using methods such as viral transduction, electroporation, or chemical transfection.
• Selection and screening: After transfection, large cell populations are screened by quantitatively measuring the expression of cell surface target protein or secreted antibody (titer determination) to increase the probability of finding high-affinity products or high-producing cell lines.
• Clonal isolation: Once high-producing clones are identified, they are isolated and expanded to establish stable cell lines. This usually involves single-cell cloning to ensure that each cell line is derived from a single clone.
• Clonal yield screening: This is a test method to measure the amount of recombinant protein or antibody produced by a clonally derived cell line.
• Cell line characterization and validation: The final step in cell line development is the characterization and validation of the selected cell line. This involves evaluating the stability of protein production, growth characteristics, and other important parameters to ensure that the cell line is suitable for large-scale production.
• Expansion: Expand clones and perform downstream bioprocesses.
• Construct a research cell bank: After completing the above steps, we will construct a research cell bank containing multiple stable cell lines that highly express the target protein. These cell lines can be used for further functional studies, protein interaction analysis, drug screening, and toxicity testing.

Highlights of Our Cell Line Development Platform

• Highly optimized host cell lines and proprietary vectors.
• Proprietary CHO expression platform.
• Quality-based and high-titer clone screening.
• Efficient plasmid transfection system.
• High-throughput screening of cell clones.
• Customized cell culture media.
• Evaluation of cell line stability.
• Upstream process development.

Why Choose Us for Cell Line Development?

• We support the development and production of a variety of molecular drugs of varying complexity, including monoclonal antibodies, polyclonal antibodies, recombinant proteins, etc.
• Based on our advanced cell line development platform, we have successfully constructed hundreds of stable cell lines for clinical and commercial production.
• We have a high-yield, fast, and stable cell line development platform that allows the selection of high-quality stable expression clones based on expression and quality.
• We provide flexible solutions, you can develop the cell line of your interest with us from the beginning, or you can seamlessly transfer your existing cell line to our facilities.
• We provide cell line pre-study services for vector optimization, and variant and signal peptide screening to provide support materials for your toxicology studies.
• We provide a complete report when the product is delivered, including a series of clinical experiments and CMC quality control release documents such as quality inspection reports, cell line construction reports, cell traceability documents, etc.

Publication

Thanks to decades of experience in cell line and biopharmaceutical development, as well as a wide variety of expression hosts and processes, CD Formulation can find the best solution for your protein and peptide molecules. We are committed to being your most trusted partner to meet all your needs for producing protein therapeutics using cell lines. Please don't hesitate to contact us if you are interested in our services. We look forward to cooperating with you.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.