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Monoclonal Antibodies: From Screening To Production

Monoclonal antibodies have been used for testing kits and medical therapies across a wide range of applications. The production of monoclonal antibodies is well understood, scalable, and standardized because it is a good general example of a modern bioprocess.

It is this aspect that will be the focus of this brief review. To know more about monoclonal antibodies, you can navigate

Specific methods for making hybridomas were developed in the 1970s and refined and expanded over the decades. The steps from clone formation to the final product follow a standard route for protein products derived from modified mammalian cell lines.

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The main steps for making monoclonal antibodies include:

• Making and selecting hybridoma branches for main seeds

• Preparation of seed carts in T-bottles, shake flasks, or roller bottles

• Switch to a rock bioreactor (optional bag) to increase seed yield

• Production up to 20,000 l

• Downstream processing and storage

Production scale

This can be thousands of liters and is a significant investment in time, resources, and costs. The high value of the product justifies the cost, but any increase in process efficiency will have a big impact on reducing costs.

The increased time is usually 3 to 5 months from start to finish, depending on the clone results and the number of antibodies required. This includes the production of suitable clones of the purified antigen, cultivation in a flask and bioreactor, followed by post-treatment.

The production of monoclonal antibodies using hybridoma cells predates the commercial use of recombinant DNA technology to produce human insulin. Therefore, it is an excellent example of a modern bioprocess involving skills in many disciplines.