The Cell Line Characterization Services Market, 2017-2027′ report features a comprehensive view on the current market landscape and future outlook of testing and/or authentication services for the characterization of cell lines. The report provides information on organizations that offer contract services for the characterization of cell lines.
Cross contamination and cell line misidentification are some of the major concerns associated with the use of cell lines. According to published literature, cell lines used for scientific experiments are either misidentified or contaminated in approximately 15-25% cases. The use of such cell lines yields unreliable and irreproducible results, and leads to significant delays in research time lines and financial losses. The detrimental impact of using incorrect/misidentified cell lines poses a significant burden on the global healthcare budget
It has been estimated that a net loss of USD 28 billion is incurred every year on research that cannot be replicated due to the involvement of misidentified or contaminated cell lines in the US. Therefore, it is crucial to properly identify and authenticate cell lines used for research, both at the start of a project, as well as during the course of the study. To carry out cell line characterization, factors such as source of cell lines, their development history and the biological properties of cells determine the analytical tests required for characterization.
It is also worth highlighting that several regulatory authorities and scientific communities have undertaken different initiatives to spread awareness on the importance of cell line characterization. Various rules and standards have also been formulated, making it mandatory to characterize cell lines while submitting applications for marketing authorization, for receipt of grants/funds, or for publishing cell-based research in leading journals.
Key Topics Covered:
2. EXECUTIVE SUMMARY
Introduction to Cell Culture and Cell Lines Cell Banks Cell Line Characterization Outsourcing of Cell Line Characterization Services
4. CELL LINE AUTHENTICATION
Need for Cell Line Authentication Cell Line Authentication: Historical Timeline Cell Line Authentication: Role of American Type Culture Collection (ATCC) Cell Line Authentication: Role of International Cell Line Authentication Committee (ICLAC) Cell Line Authentication: Role of Global Biological Standards Institute (GBSI) Factors Contributing to Cell Line Misidentification Awareness Surveys STR Profiling Kits Cell Line Authentication: Competitive Landscape
5. REGULATORY RECOMMENDATIONS AND GUIDELINES
Guidelines Issued by International Regulatory Agencies Regulatory Guidelines for Cell Line Characterization in the US Regulatory Guidelines for Cell Line Characterization in Europe Regulatory Guidelines for Cell Line Characterization