GMP Cell Banking is an important component in the production of well-characterized biopharmaceutical products. A qualifies cell bank provides the opportunity to detect and identify possible contaminating agents such as viruses and mycoplasma before their use in a large scale. A cell bank ensures uniform population of cells preserved for better health to ensure better products. Cells preserved in banks are then used as a start material for each manufacturing. The importance of GMP cell banking ensure the integrity of cells and is maintained with sufficient supply of material to the cell for the better life of byproduct. Cells stored in GMP Cell banking is used for meeting manufacturing needs for the production of cell in recombinant biopharmaceuticals and vaccine production. In any GMP cell banking service, a proper cell-bank testing plan is necessary to certify purity and safety of a resulting biopharmaceutical product. All type of cell bank service requires expertise, constant monitoring, optimal equipment, appropriate quality control, proper environment, close communication and continuous troubleshoot. Cell banking service requires characterizes the cell line and require an array of tests to be performed in different scenarios. The various type of testing is performed to find the adventitious agents testing to identify and genetic stability testing. It is required to know what the best time to perform these tests is and how these tests impact the project outcome. The sudden increase in demand for ready-to-use cells is increasing the demand for GMP cell banking service. Services provided by GMP cell banking service provided includes: maintaining the master cell line for years, maintaining working cell line with the low passage, identity confirmation by fingerprinting, purity testing for mycoplasma, viruses and fungi detection, and stability testing for expression constructs and viral vectors.
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The cell banking service process includes both GMP production and Non-GMP production master cell bank. The type of GMP cell banking includes the type of services such as working cell bank (ECB), end-of-production (EOP) and research and development (R&D) cell banks. GMP cell banking service market is an emerging field. There are various tests and procedures to be followed by the service providers to a high-quality service. Many biopharmaceutical and pharmaceutical companies are very active in the field of GMP cell banking service. The ongoing worldwide research is expected to fuel the GMP cell banking service market. Within the diagnostic segment of the GMP cell banking service, most of the focus has been on the detection of contaminations and maintaining the health of cells. Most of the activity and interest of the companies is focused on the therapeutic research of the GMP cell banking service field.
The global market for GMP cell banking service market is expected to be driven by the advancement in technology of molecular and genetic studies. The key drivers of the market are the increasing cases prevalence of cancer, infectious disease and other diseases creating focus towards the requirement of more research for drug discovery. Moreover, the increasing research activities for drug development, growing research on cancer and increasing collaboration between research organizations, pharmaceutical, and biopharmaceuticals companies is also acting as a fuel to the GMP cell banking service market and is expected to drive the market within the forecast period of 2016-2026. However, the high cost of the procedures and the lack of fund can be the restraint for the growth of this market.
The GMP cell banking service market is classified on the basis of product, end user and geography.
Based on product, the global GMP cell banking service market is segmented into the following:
- Working Cell Bank (ECB)
- Master Cell Bank (MCB)
- End-of-Production (EOP)
- Virus Bank
- Research and Development (R&D) cell banks
Based on end user, the global GMP cell banking service market is segmented into the following:
- Academic Research Institutes
- Biotechnology Companies
- Biopharmaceutical Companies
- Pharmaceutical Companies
- Contract Research Organizations
- Contract Manufacturing Organizations
The number of companies developing methods to detect and modifying DNA for diagnosis and therapeutic purposes has significantly changed in recent years. The increasing investment by the pharmaceutical and biotechnology companies towards research and development is expected to drive the market. Based on the product working cell bank (ECB), master cell bank (MCB), end-of-production (EOP), virus bank and research and development (R&D) cell banks.
By end user, the global GMP Cell Banking Service market has been segmented into academic research institutes, biotechnology companies, biopharmaceutical companies, pharmaceutical companies, contract research organizations and contract manufacturing organizations. GMP cell banking service procedures are useful in many research oriented areas such as developmental biology, oncology, drug discovery and others.
By regional presence, GMP cell banking service market is segmented into five key regions viz. North America, Latin America, Europe, Asia-Pacific, and the Middle East & Africa. North America will continue to dominate the GMP cell banking service market for due to high availability of funding for research and better economic conditions. Europe is expected to hold second largest market share in global GMP cell banking service market. The growing government initiatives to support research activities and increasing number of biotechnology and biopharmaceutical companies in APAC are also driving the market for GMP cell banking service in APAC.
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Some of the major players in global GMP cell banking service market include Virusure, Syngene, Sigma-Aldrich Co. LLC., WuXi AppTec, Zelle Biotechnology Private Limited, Microbiology Quality & Associates, Charles River Laboratories International, Inc., IHC World, LLC., Paragon Bioservices, Inc., Austrianova, VertMarkets, Inc. and others.
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