Question 1

Can your platform achieve the expression levels required for my therapeutic or diagnostic antibody project?

Accepted Answer

Yes! Our platform is optimized to deliver high-yield antibody expression. At ProteoGenix, we offer two types of guarantees to minimize risks and time while securing high yields:
1.	A yield guarantee, which is estimated based on the sequence to be produced at the beginning of the project. This guarantee secures your investment and provides a good estimate of what we believe we can achieve. In general, we are often able to achieve yields significantly higher than our initial estimate.
2.	Our service is divided into several “Working Packages,” which are typically concluded with Go/No Go decisions. At the end of each working package, you will have the option to decide whether to continue the service or stop, paying only for the work completed!

Question 2

Can you support difficult-to-express antibodies or formats (e.g., bispecifics, Fc-engineered constructs)?

Accepted Answer

Absolutely, more than 100 projects were successfully completed using our platform of stable cell line generation for monoclonal antibody production with a productivity record of 10 g/L. These projects ranged from the production of full-length IgG, bispecific antibodies, Fc-fusion proteins, and antibody fragments, including Fab, scFv, or VHH.
Our platform is designed to ensure that even the most complex candidates can be produced at their full expression potential, while maintaining high quality.

Question 3

Which expression systems can you use with our stable cell line generation service for your monoclonal antibody production?

Accepted Answer

Proprietary CHO-K1, as well as CHO-DG44, CHO-S, and HEK cell lines adapted for suspension culture, are available through ProteoGenix’s stable cell line generation service. We can also develop stable cell lines using customer-provided cell lines.
Alternatively, given our 28+ years of experience in recombinant antibody production, we can produce antibodies in a variety of non-mammalian systems including bacterial (Escherichia coli, Bacillus subtilis), yeast (Saccharomyces cerevisiae, Pichia pastoris), and insect/baculovirus systems. These systems may be particularly interesting for the production of antibody fragments or antibodies intended for non-therapeutic use.

Question 4

How customizable is the workflow for cell line development?

Accepted Answer

Our workflow is fully flexible and designed around your project needs. We can use our royalty-free CHO-K1 cell line or discuss other cell line development, as we are fully flexible! After generating stable cell pools, our standard screening process is ELISA, but we can adjust to your needs (WB, protein activity tests for example). At every key stage, our Go/No-Go checkpoints give you the option to pause, adjust, or redirect the project to ensure it aligns with your goals.

Question 5

How do you assess monoclonality, productivity, and product quality during the process?

Accepted Answer

We use state-of-the-art techniques at different stages to ensure confidence in your cell line and antibody quality.
Regulatory agencies today increasingly prefer automated methods. Therefore, for monoclonality assessment, we verify single-cell origin using VIPS™ technology, a real-time imaging system that documents a single cell in each well and tracks its outgrowth. VIPS™ generates a Clonality Report, providing robust documentation that supports regulatory compliance and streamlines your approval processes.
To ensure productivity, our high-throughput antibody production platform allows us to perform screening, quantify titers, and identify the most promising sequences. For additional reassurance, you can optionally test these candidates in your own lab and evaluate affinity, purity, aggregation, and thermostability.
Extensive QC testing tracks and ensures antibody quality in early stages of development, and once you have the final product. Key tests include glycosylation profiling, aggregation, endotoxin detection, and purity, analyzed using techniques such as LC/MS, SEC-HPLC, Biacore™, SDS-PAGE, and DSC.

Question 6

Can you provide detailed documentation packages suitable for tech transfer to CDMOs?

Accepted Answer

During the project, we will provide detailed documentation on the cell line for cell transfer to a CDMO. We also partner with CDMOs to facilitate the transfer of cell lines for GMP production.
Full-length monoclonal antibodies are often produced in mammalian expression systems such as Chinese hamster ovary (CHO) or mouse myeloma (NS0) cells. At ProteoGenix, we specialize in CHO cell lines offering a large diversity of hosts including our proprietary CHO-K1 cell line and also CHO-DG44 (a cell line lacking both alleles of DHFR, suitable for metabolic selection) or CHO-S, among others.
After over 28 years of experience in protein production in different expression systems (mammalian, bacterial, yeast, insect), CHO-based stable production is our system of choice when expressing antibodies. CHO cells are more tolerant to changes in pH, temperature, pressure, and oxygen concentrations. Plus, they are more amenable to gene amplification leading to production levels significantly higher than those achieved by other production systems. Plus, CHO cells produce proteins with glycosylation profiles similar to humans resulting in lower immunogenicity and optimal therapeutic efficacy.
In contrast, antibody fragments devoid of glycans may be produced faster at high titers in simpler systems such as bacterial cells (e.g. Escherichia coli or Bacillus subtills) known for their high turnover rates. The simpler genetic background of bacteria makes them more amenable to manipulation and scale-up. However, antibodies in E. coli are produced in the cytoplasm or periplasm requiring harsher extraction methods.

Question 7

What is included in the final deliverable—vials, data packages, stability studies, etc.?

Accepted Answer

At ProteoGenix, our goal is to give you full confidence along every step of your cell line development process. Depending on your project, the final deliverables can include purified antibody vials, full analytical data packages, and stability studies.
During stable cell pool generation, we provide detailed reports on genetic material production, cell transfection, culture, and antibody titration to help select the best polyclonal pools. You’ll also receive purified antibodies from these pools, and if you wish, we can prepare a bank of your top-selected pools.
For single-cell clone screening and subcloning, we provide a comparison report of the top 10 monoclones, purified antibodies from each, and preparation of RCBs from the top 3 clones. We perform quality control before and after freezing—including viability, cell counts, mycoplasma and sterility testing—so you can be sure your clones are ready for long-term use. Each RCB comes with a full report and a Certificate of Analysis of the RCBs, along with 10 vials of the top-selected clone.
We also perform RCB stability studies, monitoring the top 3 clones over multiple generations to confirm consistent growth, yield, stability, and antibody identity.
All of these deliverables are designed to give you traceability, reproducibility, and confidence, so your cell lines are fully characterized and ready for scale-up or preclinical development.

Question 8

Do you offer both fast transient screening and stable line generation to compare candidates?

Accepted Answer

Yes. At the start of your project, you can choose to begin the workflow with transient expression screening to engineer and optimize sequences and ultimately identify your top candidates. Additionally, you can optionally test these candidates in your own lab under your experimental conditions to evaluate affinity, purity, aggregation, and thermostability. This is then followed by stable cell line generation to ensure scalable and consistent production.

Question 9

What are the unique advantages of your cell line generation service?

Accepted Answer

Using advanced VIPS™ technology, ProteoGenix accelerates custom cell line projects by more than 50%, providing high-resolution verification and ensuring precise monoclonality. This efficiency not only shortens your project timelines but also increases the reliability and consistency of results, making it an invaluable asset in therapeutic antibody production. Additionally, our robust documentation process, includes a detailed Clonality Report, which can be directly used for IND submissions, ensuring your project is compliant with regulatory requirements.
In addition, our service includes a comprehensive early testing phase. The comprehensive characterization of antibody leads allows us to predict potential production hurdles and guarantee production yields. In this way, we can protect our clients’ investments while transferring all risks directly to us.
Furthermore, you retain the intellectual property (IP) of the cell lines and protocols generated at ProteoGenix. This simplifies protocol and cell transfer to a CMO or your facilities for large-scale production. Our FTO (freedom-to-operate) stable cell line generation ensures a smooth transition from the bench to large-scale bioreactors and greatly simplifies the process of licensing your antibodies for therapeutic or in vitro diagnostic applications.
As experts in custom recombinant antibody production, high-throughput antibody production services, and engineering, we also offer a wide range of upstream services, including affinity maturation, antibody humanization, bispecific antibody development, antibody-drug conjugate development, and antibody reformatting. Our downstream capabilities include research cell bank development and stability studies. By partnering with us, you can save time and reduce costs while maximizing the therapeutic efficacy of your antibody leads and minimizing foreseeable production risks.

Custom Cell Line Development