1. Dr Caroline Pennington Chief Scientific Officer RSE/BBSRC Business Enterprise Fellow Telephone: 01603 591579 Email: caroline@genid.co.uk Website: www.genid.co.uk Cell Authentication and Validation

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

4. Major trials of drugs in doubt (BBC news 2010)

5. A case of mistaken identity: An Example:

6. An Example:

7. An Example: £62K!!

8. 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.

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

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

12. Single Nucleotide Polymorphism (SNP) Panel Cell Validation AGCAGGACA HeLa cells AGCATGCCAGGATTGCTA MCF7 cells U251 cells

13. 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 Cell check recommendations

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

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

16. Normal Cancer NormalMarginCentre BPH Cancer Breast Prostate ENT Breast

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

18. 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

19. 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.

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