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Balancing High Production & Quality in Biopharmaceutical Generation

October 31, 2014

University of Tokushima, Japan.

"The AlphaLISA® CHO HCP (broad reactivity) kit is very effective for the rapid evaluation of HCP concentration, and strongly supports the determination of the end-point of mammalian cell culture."

- Professor Takeshi Omasa, Institute of Science and Technology, University of Tokushima, Japan

Professor Takeshi Omasa's laboratory within the Institute of Science and Technology at the University of Tokushima focuses on the application of mammalian cells and microbials to the bio-industry. They are also developing new cell lines and constructing bioprocesses for use in the development of biopharmaceuticals, such as therapeutic glycoprotein.

Mammalian cell lines are important host cells for the industrial production of biopharmaceutical proteins as they allow the correct folding, assembly and post-translational modification of proteins. Chinese Hamster ovary (CHO) cells are considered the most dependable host cells for biopharmaceutical production.

Both Protein Producing and a Source of Contamination

CHO cells are an indispensable host cell line for therapeutic protein production, with more than 30% of therapeutic proteins being produced using them. The growing demand for biopharmaceuticals requires the parallel development of technologies for enabling high quality and productivity in CHO expression systems.

The use of cell culture expression systems to generate biopharmaceuticals often results in contamina-tion of the final product with host-cell proteins (HCP), which can lead to potentially deleterious side effects if administered to patients. Longer cell culture times cause a higher concentration of the desired recombinant protein, but also an increase in the amount of HCP contamination. Determining an appropriate end-point for cell culture is therefore an important but difficult task.

Finding the Right Balance Between Protein Production and Quality

Professor Omasa’s team are involved in a variety of projects relating to CHO cells, such as their genomic analysis, cell engineering for use in biopharmaceutical production, and quality control of the cell line. Because a trade-off needs to be established between the total amount of the desired recombinant protein produced and the quality (contamination levels) of the product, they use PerkinElmer’s AlphaLISA® CHO HCP (broad reactivity) kit in their studies.

The kit lets them perform accurate and rapid evaluation of HCP concentration, an essential step for GMP-certified production using CHO cells. The data obtained using these kits assists in their determination of the end-point of mammalian cell culture and provides other important parameters related to CHO cell cultivation, such as cell viability and viable cell condition.

Bringing Biopharmaceuticals to the Global Market

To date, more than 40 products produced by mammalian cell cultivation have been launched into the market and large-scale (more than 20,000 liters) cultivation is performed all over the world. Professor Omasa’s team and their collaborators are making significant contributions to this global knowledge base.

For Research use only. Not for use in diagnostic procedures.

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