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Cell Authentication and Validation

Cell culture cross-contamination remains a significant challenge in laboratories globally, potentially jeopardizing drug trials and research integrity. To combat this issue, experts assert the importance of cell line authentication and propose that funding agencies and scientific journals mandate authentication for grant opportunities and publications. This initiative aims to protect research quality by verifying the identity and purity of cell lines used in studies. With the establishment of independent cell validation services, researchers can ensure consistent quality in their work, promoting integrity in scientific discoveries.

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Cell Authentication and Validation

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  1. Cell Authentication and Validation

  2. A Case of Mistaken Identity: Cell culture cross contamination is a long standing problem in laboratories worldwide

  3. ‘Major trials of drugs in doubt’ (BBC news 2010)

  4. A case of mistaken identity: An Example:

  5. An Example:

  6. An Example: £62K!!

  7. A Call for Action: Eradication of Cross Contaminated Cell Lines: Roland M Nardone • ‘1. It is proposed that government and private funding agencies be prevailed upon to require cell line authentication as a condition for the award of grant and contract funds. • 2. It is also proposed that key scientific journals be prevailed upon to require cell line authentication as a condition for publication.’

  8. 9. Cell Line Authentication. The authentication of cell lines is considered an important part of the preliminary data described in any grant application. Applicants should also ensure that all cell lines to be used during the proposed research are adequately authenticated

  9. 9. Cell Line Authentication. The authentication of cell lines is considered an important part of the preliminary data described in any grant application. Applicants should also ensure that all cell lines to be used during the proposed research are adequately authenticated

  10. The First Independent Cell Validation Service Management Team: UEA Management Consultancy Ltd Caroline Pennington Professor Dylan Edwards

  11. Single Nucleotide Polymorphism (SNP) Panel Cell Validation AGCAGGACA AGCATGCCA GGATTGCTA HeLa cells MCF7 cells U251 cells

  12. Cell check recommendations • at the commencement of a project and then at six monthly periods to ensure cells remain uncontaminated. • to ensure batch to batch identity • following long term storage and genetic manipulation of cultured cells • in multi user laboratories • for cells obtained from inter laboratory exchange • for newly generated cell lines • following ‘cell rescue’ cell sorting etc

  13. Business Model Contracts BioManufacturing, stem cell Co. Pharmaceutical R&D Gene expression profiling Collaboration ATCC, ECACC/HPA Immunosolv FACs Academic institutes BioTech(UK, Europe, US) Training and support Bespoke BioManufacturing, Academic institutes, Pharmaceutical R&D For the future: Cell mycoplasma testing Species specific Id TaqMan Low Density Array servicing

  14. Bespoke Expression profiling Cell line RNA PDAC RNA KO p53 no metastases PDAC RNAmutant p53 metestatic PDAC

  15. Cancer Normal BPH Cancer Normal Margin Centre Breast Breast Prostate ENT

  16. Gene Expression Profiling:From Tissue to Data RNA Bacteria Plant tissue Human tissue Mouse tissue Rat tissue Cultured cells miRNA

  17. Pharmaceutical R & D Biomanufacturing – 70% of companies contacted express an interest Avecia, Eden Biodesign ‘add to quality assurance in bioproduction and ….it would be an advantage that they could offer and pass on to their customers.’ Academic research institutes - interest in investigating batch to batch variation and in getting papers published and funding released Cell suppliers The market

  18. Experience, Expertise and reputation • 10 years experience • Over 60 collaborators worldwide • 72 published papers and 3 book chapters • coordinated a 5 year European Union Programme involving 41 Partner laboratories in 13 countries.

  19. Independent validation • Working to ISO accredited procedures • A contracted or flexible bespoke services

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