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Sean Huang

The Role of Recombinant Antibody Expression in Drug Development


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What is Recombinant Antibody?

Recombinant antibodies are antibody fragments generated in vitro through the use of synthetic genes. It brings many advantages, such as high specificity and low immunogenicity levels.


Why is recombinant antibody expression important?

Recombinant antibody expression is the key element in the development of any antibody-derived drugs. It’s required in the process of Antibody Generation and Antibody Optimization. (Fig.1) Recombinant antibody transient expression allows the researchers to predict, screen, and confirm the safety and efficacy of a target antibody in high throughput methods.


Antibody-drug Development Process

The development of antibody drugs involves several stages prior to clinical trials. 1. Target identification To identify a potential target for the antibody, such as a specific protein that is associated with a disease. 2. Antibody generation The identified target will be used as antigens to initiate an immune response in host animals. Then, the generated antibodies will be screened to find the ideal antibody candidate that has strongest binding activity and specificity. 3. Antibody optimization Antibody candidate is modified and further optimize in this stage to improve its effectiveness and affinity. In some cases, antibody humanization step is required. 4. Preclinical studies Safey and efficacy are assessed in animal studies to decide if it can procced to clinical trials.


Antibody-drug Development Process

Fig.1 Antibody-drug Development Process

Antibody Therapeutics, Volume 6, Issue 1, January 2023, Pages 13-29


Challenges along the development process

One of the major challenges associated with the process of antibody drug development is the expression of recombinant antibodies. This is a critical step to create highly specific and effective antibodies that can target disease-causing proteins.

However, this process can be complex and time-consuming, requiring specialized expertise and equipment. Many companies opt to outsource the production of recombinant antibodies to multiple CROs, which can cause difficulties in terms of coordination and quality control. Alternatively, some companies choose to invest in developing in-house capabilities for recombinant antibody expression, which can be expensive and low efficient.



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