Bulk Antibody Production Service through Bioreactor

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Using bioreactors to produce antibodies presents many advantages including better control of culture conditions, increased antibody yield, and to manufacture desired amount of antibodies. Bioreactor platforms at Creative Biolabs have proven to be a highly reliable and cost-effective alternative. Creative Biolabs provides both small and large-scale capacities in our production facility and also offers cell line optimization/adaptation services to specialize culture media for worldwide customers.

Background

There are a variety of system types designed for harvesting monoclonal antibody (mAb) in vitro, including static culture (in flasks), ceramic or hollow fiber matrix cartridges, and roller bottle/dialysis cartridges. Each system has distinct advantages and disadvantages. Bioreactor systems have appeared on the market designed specifically for the large-scale production of mAbs and as a non-animal use alternative to ascites mice.

Bioreactors designed for continuous culture of productive hybridoma lines are equipped with specialized cartridges to cultivate cells in dense populations and harvest mAb in concentrated amounts. Hybridoma cells are grown in a dense population without the risk of poisoning themselves with the toxic metabolites that they produce. A larger volume of fresh media continually replenishes the cells with nutrients and dilutes out the waste products. It would take approximately 8-12 ascites mice to yield the same total harvest of antibody from one bioreactor cartridge. The cartridges provide an alternative to the use of animals for antibody production. In some cases, hybridoma cells do not produce well in mice and a bioreactor system offers a feasible alternative for obtaining large quantities of antibodies. The bioreactors also provide an antibody product that contains fewer mouse proteins and nonspecific antibodies when compare to the ascites product.

Factors affecting mAb production. (Creative Biolabs Original) Fig.1 Factors to be considered in large-scale mAb production.

Our Bioreactor Production Services

Using the bioreactor system, Creative Biolabs can produce mg to gram quantities of mAbs quickly. Our bioreactors allow the growth of antibody-producing cells at 20-30-fold higher density and therefore greatly increase secreted product concentrations, up to 100-fold. The technology adopted by the technical team allows for long-term, continuous culture from which a high concentration of antibody can be obtained for several weeks or months with standard techniques.

Scope of Work

Clonality testing of cell lines to ensure optimal production of antibodies prior to scaling up will be completed. If cells are determined not to be clonal, additional sub-cloning and cell culture fees may apply. Cells can be adapted to grow in chemically defined protein-free, serum-free, animal-derived component-free media if required.

Bioreactor start-up includes assembly, sterilization of bioreactor, and expansion of seed culture to obtain a sufficient number of cells for inoculation.

Weekly maintenance and harvesting. Each bioreactor harvest lot is clarified by aseptic filtration or centrifugation to remove cell debris.

Antibody purification. Low endotoxin purifications are available for functional studies.

The following standard testing will be performed on each lot of purified antibodies:

Purity by SDS Page Gels (Reduced and Non-reduced)
Antibody Concentration by A280
Endotoxin Level
Reactivity to antigen by ELISA/WB (optional)
Reactivity to antigen by flow cytometry (optional)

FAQ

Q1: What should I prepare for the service?
A: Generally, please provide at least two frozen vials of each hybridoma cell line containing sufficient viable cells to initiate the culture required for production.
Q2: What can we receive?
A: Final deliverables typically include:
- Purified mAb products to the requested scale, or concentrated supernatant
- The working cell bank (WCB) for scale-up hybridoma cell line
- Exhaustive project report with experiment records and data

Creative Biolabs is a well-recognized leader in the field of antibody discovery and development. We provide antibody bulk production services to produce high-specificity and sensitivity antibodies. Please contact us for more information if you are interested in our services.

All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.

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