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Cell lines suitable for stable production of antibodies or recombinant proteins must have good performance and be able to be scaled up for commercial GMP production. Creative Biogene, a leader in GMP cell line production, offers a variety of advanced technologies to fully evaluate the viability and performance of host cell lines for production in accordance with Good Manufacturing Practices (GMP).
In addition to providing the most widely used host, Chinese hamster ovary (CHO) cells, for large-scale production, Creative Biogene can select the appropriate host cell line for the customer's production needs and thoroughly evaluate it to ensure stable, high-yielding and scalable performance in subsequent GMP production. Our experienced scientists have developed a comprehensive set of criteria to assist customers in the selection of cell lines, including product quality, yield, scalability and regulatory compliance.
Creative Biogene has accumulated extensive experience in cell line development and production which allows us to provide professional evaluation services in the following aspects to screen the most suitable host cell lines for our clients.
Fig. 1 Host Cell Line Evaluation Services of Creative Biogene.
The stability of cell lines may affect the quality and consistency of the product and even pose some safety risks. Creative Biogene evaluates host cells by genetic characterization, passage number and stability tests to gain insight into their stability.
Creative Biogene offers a variety of advanced methods for evaluating the performance of host cell lines in terms of productivity and reproducibility. In addition, our talented scientists can optimize these properties for GMP production. For example, we offer CHO cell lines that are fully characterized and optimized to grow at high rates with high secretion capacity. It has multiple advantages such as efficient energy metabolism without excessive secretion of by-products, well-adjusted protein secretion and glycosylation mechanisms, and remains stable in terms of product quality and productivity.
The host cell line must be able to scale up production to meet the requirements of large-scale GMP production without loss of productivity or quality. Creative Biogene’ scientists help customers select host cell lines by evaluating batch-to-batch consistency, production equipment, manufacturing processes, media and feed strategies to ensure the scalability of host cell lines for GMP production.
Creative Biogene's host cell line evaluation process complies with relevant regulatory guidelines, such as the International Conference on Harmonization (ICH) guidelines, and how to make host cell lines GMP compliant for production.
Creative Biogene has over a decade of experience in the field of cell line development. Our extensive project experience allows us to provide our clients with a multifactorial evaluation strategy to screen for the most suitable host cell lines. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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