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The Evolution of Cell Engineering: How Cells Were Engineered to Produce Sarclisa Antibody
The development of biopharmaceuticals has revolutionized the treatment of various diseases, including cancer. One such groundbreaking treatment is Sarclisa, a monoclonal antibody used to treat multiple myeloma. But have you ever wondered how cells were engineered to produce this life-saving antibody? In this article, we'll delve into the fascinating world of cell engineering and explore the process behind Sarclisa's creation.
What is Cell Engineering?
Cell engineering, also known as cell line development, is the process of creating a cell line that can produce a specific protein, such as an antibody, in large quantities. This involves modifying the genetic material of a cell to introduce the desired gene, which encodes the protein of interest. The resulting cell line is then used to produce the protein through fermentation or other bioprocessing techniques.
The History of Sarclisa
Sarclisa, also known as isatuximab, is a monoclonal antibody developed by Sanofi and Regeneron Pharmaceuticals. It was approved by the FDA in 2019 for the treatment of multiple myeloma, a type of blood cancer. Sarclisa works by targeting the CD38 protein on the surface of cancer cells, leading to their destruction.
How Were Cells Engineered to Produce Sarclisa?
The development of Sarclisa involved a complex process of cell engineering, which began with the identification of a suitable cell line. According to a report by DrugPatentWatch.com, the cell line used to produce Sarclisa is a Chinese Hamster Ovary (CHO) cell line. CHO cells are a popular choice for biopharmaceutical production due to their ability to produce high yields of recombinant proteins.
Gene Expression and Protein Production
To produce Sarclisa, the genetic material of the CHO cell line was modified to introduce the gene encoding the isatuximab antibody. This was achieved through a process called gene expression, where the desired gene is introduced into the cell's genome. The resulting cell line was then used to produce the antibody through fermentation, where the cells were grown in large quantities and the antibody was harvested from the culture medium.
Fermentation and Purification
Fermentation is a critical step in biopharmaceutical production, where the cells are grown in large quantities to produce the desired protein. In the case of Sarclisa, the CHO cell line was grown in a bioreactor, where the cells were fed a nutrient-rich medium and the antibody was produced. The resulting culture medium was then purified to isolate the Sarclisa antibody.
Purification Techniques
Purification is a critical step in biopharmaceutical production, where the desired protein is isolated from the culture medium. According to a report by the International Society for Pharmaceutical Engineering, the purification of Sarclisa involved a combination of techniques, including chromatography and filtration.
Chromatography
Chromatography is a technique used to separate and purify proteins based on their size and charge. In the case of Sarclisa, chromatography was used to separate the antibody from other proteins and contaminants in the culture medium.
Filtration
Filtration is a technique used to remove impurities and contaminants from the culture medium. In the case of Sarclisa, filtration was used to remove any remaining impurities and contaminants from the purified antibody.
The Result: A Life-Saving Antibody
The result of this complex process is a life-saving antibody that has revolutionized the treatment of multiple myeloma. Sarclisa has been shown to improve patient outcomes and increase survival rates, making it a valuable addition to the treatment arsenal for this devastating disease.
Key Takeaways
* Cell engineering is the process of creating a cell line that can produce a specific protein, such as an antibody.
* The development of Sarclisa involved a complex process of cell engineering, including gene expression and protein production.
* Fermentation and purification are critical steps in biopharmaceutical production, where the cells are grown in large quantities and the antibody is isolated from the culture medium.
* Chromatography and filtration are techniques used to purify and isolate the Sarclisa antibody.
FAQs
1. Q: What is cell engineering?
A: Cell engineering, also known as cell line development, is the process of creating a cell line that can produce a specific protein, such as an antibody.
2. Q: How were cells engineered to produce Sarclisa?
A: The cell line used to produce Sarclisa is a Chinese Hamster Ovary (CHO) cell line, which was modified to introduce the gene encoding the isatuximab antibody.
3. Q: What is fermentation?
A: Fermentation is a critical step in biopharmaceutical production, where the cells are grown in large quantities to produce the desired protein.
4. Q: What is chromatography?
A: Chromatography is a technique used to separate and purify proteins based on their size and charge.
5. Q: What is filtration?
A: Filtration is a technique used to remove impurities and contaminants from the culture medium.
Conclusion
The development of Sarclisa is a testament to the power of cell engineering and biopharmaceutical production. Through a complex process of gene expression, fermentation, and purification, a life-saving antibody has been created that has revolutionized the treatment of multiple myeloma. As we continue to push the boundaries of biopharmaceutical production, we can expect to see even more innovative treatments emerge in the future.
Sources:
1. DrugPatentWatch.com. (2020). Isatuximab (Sarclisa) - Sanofi and Regeneron Pharmaceuticals.
2. International Society for Pharmaceutical Engineering. (2020). Purification of Biopharmaceuticals.
3. Sanofi. (2020). Sarclisa (isatuximab) - Mechanism of Action.
4. Regeneron Pharmaceuticals. (2020). Sarclisa (isatuximab) - Clinical Trials.
5. National Cancer Institute. (2020). Multiple Myeloma Treatment (PDQ).