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Cell lines are one the major tools used in research for studying the normal physiology and biochemistry of cells, the effects of drugs and toxic compounds on the cells, drug screening and development and large scale manufacturing of biological compounds. Cell culture is the process by which cells are grown under controlled conditions derived from microbial or animal cells. Cell lines are subculture of primary culture also known as subclone. Cell lines derived from primary cultures have a limited life span, after subsequent cultures, cells with the highest growth capacity dominate which are selected for further cell development. Primary cells are cells that are cultured directly from a subject and have a limited lifespan. An immortalized cell line can proliferate indefinitely either through random mutation or deliberate modification which are useful especially for production of therapeutics.
The cell line development service market is expected to grow at double digit CAGR to reach $1,214.7 million by 2025. Increasing demand for biologics and biosimilars, growing incidence rate of oncology and immunological disorder and growth in research activities related to the diseases are driving the market. Technological improvements in development, manufacturing, screening technologies and assays are giving immense growth opportunity for the market. However, complexities in development of stable cell lines and high risk of contamination due to complex purification methods are restraining the market. Furthermore, stringent and complex regulations and high cost and technical requirement to adhere with accreditations such as GMP are posing threat to the industry.
Cell lines are essential for a wide range of applications including gene function studies, drug discovery assays, the production of biotherapeutics and diagnostics. The application for cell lines includes research, bioproduction and diagnostics. Among research, cell lines are used for studying disease, screening, cellbased assays are used during discovery phase and preclinical development. Cell lines are used to produce a wide range of biotherapeutics including vaccine, recombinant proteins that include peptides, cytokines, hormones and clotting factors, enzymes and monoclonal antibodies.
Biotherapeutics including monoclonal antibodies, peptides, recombinant proteins, vaccines, blood related products are produced in a wide variety of platforms, including nonmammalian expression systems bacterial, yeast, plant and insect and mammalian expression systems including human cell lines. However, the most appropriate expression system to be used is dependent on the type of biopharmaceutical to be produced. Microbial systems are used for producing relatively simple recombinant proteins such as insulin or antibody fragments. They are attractive due to their low cost and high productivity. E. coli and S. cerevisiae are the most commonly used systems. However, many biopharmaceuticals including MABs, highly glycosylated proteins or recombinant proteins are large and complex, mammalian cell lines are the most preferred platform used for manufacturing them. Posttranslational modifications including glycosylation, carboxylation, hydroxylation, sulphation, amidation are a significant factor to select the type of cells to be used. Among them, glycosylation is the most common modification. Mammalian expression system commanded the largest revenue of the global cell line development services market, by expression system in 2016. The most common mammalian cell cultures used for production of biopharmaceuticals include Chinese hamster ovary CHO cells, baby hamster kidney BHK21 cells and murine myeloma cells NS0 and Sp2/0.
Among cell line type, CHO cell line is the most frequently used mammalian system, which is used in the manufacture of more than 57% of currently approved biologics. CHO cells have been the industry's cell line workhorse for production of biopharmaceuticals. These cell line has several major advantages being versatile, relatively easy to work with, having wellunderstood glycosylation patterns. Approximately 26 monoclonal antibodies and 31 recombinant proteins are produced using CHO cell lines.
The increasing demand for biologics and biosimilars has increased the demand for production cell lines. The expiration of blockbuster biologics has also driven the emergence of biosimilars. Companies are working to produce efficient and less time consuming expression systems and also using automation and robotics in screening of cell lines to speed up the process. The SUREtechnology platform by Selexis S.A Switzerland has been able to generate stable and high performing cell lines in three months with productivity levels of 17 g/L for monoclonal antibodies and about 76 drugs in clinical phase and 3 marketed drugs have been developed.
Some of the major companies in the cell line development market include Lonza Switzerland,Fujifilm Diosynth Japan , Merck KGaA Germany, Selexis S.A. Switzerland, Rentschler Biotech Germany, Horizon Discovery U.K., Sartoris Stedim France, Wuxi Apptec China, Boehringer Ingelheim Germany and Cook Pharmica U.S..
Some of the other players are Patheon The Netherlands, Syngene India, Crown Bioscience U.S., Evotec Germany, Catalent U.S., Lake Pharma U.S., TCG Lifescience India, Cobra Biologics U.K., Eurofins Luxembourg , Abzena U.K., JHL Biotech Taiwan, Charles River Laboratories U.S., Genscript China, Mabplex U.S., Trenzyme Germany, JSR Life Sciences U.S., Atum U.S., ATCC U.S..
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