1. National Institute for Biological Standards and Control Assuring the quality of biological medicines Bank Update II: focusing on contributions to R&D Lyn Healy, UK Stem Cell Bank UKSCN, Nottingham, July 2010

2. The UKSCB The UKSCB prepares and supplies worldwide, well characterised seed stocks of ethically sourced human wild type and disease-specific adult, foetal and embryonic stem cell lines. All cell lines are banked within a stringent quality framework. All activities comply with the UK Code of Practice for the use of human Stem Cell Lines.

3. Principles of the UKSCB UKSCB according to the following principles: Transparency (SC, UKSCB Code of Practice) Disseminate best practice/information Future proofing – anticipate new demands (please fill in our survey) No charge to depositors for banking/quality control Currently no charge for supply (shipment only) No conflicts of interest in basic stem cell research or commercial development

4. However: The bank can be involved as a collaborator in basic research by providing services. The bank can be involved in assay development. The bank can perform research in areas to standardise the banking process. The bank can be involved in research to better characterise stem cells The bank can be involved in projects that enhance the quality of the product. No conflicts of interest in basic stem cell research or commercial development

5. Release criteria for the cell banks Basic criteria: Viability Sterility Identity Genetic stability Why characterise the banks?

6. Correct phenotypic and function –Surface markers, RNA, differentiation/ pluripotency Correct identity –DNA profile Absence of microbial contamination – no fungi,bacteria,yeasts viruses and mycoplasma Stability of in vitro cultures: –Passage –Culture conditions Could effect outcome of future studies and data interpretation hESC line: abnormal karyotype ISCI Characterisation Adds Value to the Cell Lines Assures Quality

7. The Stem cell Community and the Bank Stem cell community has been fundamental in helping the bank to operate efficiently and effectively: Training provided through Peter Andrews and Harry Moore’s groups Involvement In the ISCF projects: ISCI projects as a hub lab providing reagents and testing ISCBI project as the co-ordinators Numerous interactions with national and international collaborators Provided insight into areas where standardisation science can be applied.

8. Highlighted Current In House Projects Feeder Study Support and expansion of a selected number of hESC lines A range of mouse and human feeders (looking at manual and enzymatic passaging). Characterising the cells over 20 passages. (Poster number 65) Novel surfaces study in collaboration with Orla Development of low resolution CGH Adjunct to traditional G-banding Genetic stability Whole population dynamics Level of sensitivity

9. Highlighted Current In House Projects Quantitative Imaging for the quality control of Cell Banks : Looking single assay to replace two QC assays. Flow cytometry for a quantitative measure of cell surface markers and in situ staining for a spatial anaysis of expression in cultures Validation of system Exploring other uses in the area of differentiation. Tool-up exercise for future projects

10. TissueFAX Flourescence and brightfield capabilities Software packages TissueQuest and HistoFax

11. My main project Development of a rapid testing method for viral targets using real time PCR in a low density array format. Collaboration with LifeTechnogies (Applied Biosystems), Rutgers University, US., Division of Virology, NIBSC and the UKSCB

12. TLDA Viral Cards Simple to use microfluidics card. Validate microarray hits quickly and economically Standardise screening of viral gene targets across multiple samples Can load 384 wells in less than five minutes without liquid-handling robots or multi-channel pipettors

13. Currently..... Targets have been validated using artificial templates and bona fide viruses Confirming that there is no cross reactivity between targets Looking at assessing copy number against the international standards (at NIBSC) for viruses Card is being tested by other interested research groups

14. Next Challenges Extension of banking activities: 2 new posts Differentiation of pluripotent cell lines: To further characterise the lines and provide further information to the Stem cell community. Scale-up and Automation: Towards clinical translation activities