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Technology Transfer for Clinical Success

Learn how to ensure successful technology transfer for clinical manufacture with detailed stages, documentation requirements, and key success factors for a robust process. Communication and partnership are emphasized for a seamless transfer process.

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Technology Transfer for Clinical Success

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  1. Ensuring Successful Technology Transfer for Clinical Manufacture Janet Downie CEO Roslin Cell Therapies 04 August 2016

  2. Roslin cell therapies • Roslin Cells Limited created 2 subsidiary companies: • Roslin Cell Therapies and Roslin Cell Sciences • Roslin Cell Sciences focused on the generation of research grade iPSCs for drug discovery • Roslin Cell Therapies focused on Cell Therapy Manufacture & Process Development ISO 9001:2008 FS 544151 Commercially confidential: Slide 2 Commercially confidential: Slide 2

  3. Roslin Cell Therapies • To be the leading cell therapy CMO and provide key cell therapy development services for our customers. • To be a ‘Centre of Excellence’ and the first choice for secure clinical trial and commercial supply. Nine BioQuarter

  4. EDINBURGH BIOQUARTER Scottish Centre For Regenerative Medicine -(230 researchers) • Building Nine • Bio-incubator CITY BYPASS (TO AIRPORT) The Royal Infirmary of Edinburgh - a major 900-bed teaching hospital Site of the Brain and Body Institute(2016) - 500 researchers Royal Hospital for Sick Children (2016) - 600-bed paediatric facility University of Edinburgh Medical School - 250 researchers and clinical staff The Anne Rowling Regenerative Neurology Clinic - £10m donation (JK Rowling) Queens Medical Research Institute (QMRI) - 650 researchers EDINBURGH CITY CENTRE Clinical Imaging Research Centre (CRIC) Commercially Confidential

  5. Cell therapy services

  6. GMP Cellular Therapy Facility 18m2 = Grade B Commercially confidential: Slide 8

  7. GMP Cellular Therapy Facility Cryo-Facility Commercially confidential: Slide 11

  8. TECHNOLOGY TRANSFER Ensuring Successful Technology Transfer for Clinical Manufacture

  9. TECHNOLOGY TRANSFER “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites”. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible and authorised party.

  10. TECHNOLOGY TRANSFER Tech Transfer Stage 1 Translation CTD Laboratories GMP facility Stage 2 Process Dev. Tech Transfer Stage 3 Tech Transfer Stage 4

  11. Process Development GMP Process development • Optimal process • Remove the perceived GMPconstraints • Streamline (testing/evaluating) • Lock in optimal process • Evaluating equipment /QC assays • Data collection and management • Train personnel • Have the end in mind • Quality by design • QC assays • scalability • Cryopreservation/bank • Product stability • Regulatory Strategy Stage 2 Process Dev.

  12. TECHNOLOGY TRANSFER Organisation – ‘Getting your ducks lined up’

  13. Documentation • Technology Transfer Protocol • Quality Agreement • Facility Assessment • Health & Safety Assessment • Skills and Training Documented • Process & Materials GMP Risk Assessment • Analytical Assay Transfer – Methods, Specifications & Qualification Commercially confidential: Slide 13

  14. Documentation • Equipment Qualification • Starting Material – Traceability & Safety • Process Validation (Normally 3 x Manufacturing Process • Technology Transfer Report • Regulatory Submission/Approval ( EU/US) • Clinical Manufacturing Commercially confidential: Slide 14

  15. ENSURING SUCESS • Develop robust, reliable and reproducible process transferable to GMP facility • Qualify QC assays • Partnership between the supplying organisation (Client) and the receiving organisation (CMO) • Joint Document approval Commercially confidential: Slide 15

  16. ENSURING SUCESS • Open and regular communication (Technical, Quality, Management) • Sharing knowledge no matter how detailed • Visits, Weekly Conference call, Daily email communication • Robust Quality Management System • Effective Change Management Commercially confidential: Slide 16

  17. ENSURING SUCESS Partnership Expecting Success Communication Well Developed Process Contingency for things going wrong Clear Plan & Documentation Commercially confidential: Slide 17

  18. Ensuring Success in Technology Transfer for Clinical Manufacture Janet Downie CEO Roslin Cell Therapies 04 August 2016

  19. The route to translation Stage 1 Translation GMP translation- Client Technical transfer • Data collection • Procurement /consent (blood) • Develop process protocols • Determine sampling points / testing strategy • Report data and develop SOP/forms • Assurance • Acquisition of true GMP grade materials • Supporting documentation • Supply for manufacture

  20. The route to translation GMP Technical Transfer • State of the art facility • 6 Clean Rooms • QC Labs and Support Areas • Production/QC/QA • Qualified Person • Hold manufacturers licence • Flexibility of Use • hESC/ iPSC production • Master Cell Banking • Allo/Autologous Therapies • Clean room isolators • Process Validation • Detailed client instructions • Clear communication • Client on site to train/observe • Clear transfer docs • Defined product specification • Perform process validation • Generate GMP documentation Stage 3 Tech Transfer

  21. The route to translation GMP Manufacture • Product manufacture • Approved GMP documentation & records • Communication with client • Clear Quality agreement defining responsibility • Clear scheduling and project management • Resolution management procedures • Quality related incident reporting system • QA Change Control Management system • QA Risk management system Stage 4

  22. Example Customers • ReNeuronCTX0E03 Production for Stoke and Critical Limb Ischemia – Phase II Clinical Trials • Pfizer – Retinal Pigmented Epithelial cells (RPE derived-hESCs for Age Related Macular Degeneration) - Phase I Clinical Trial • Cell Therapy Catapult – GMP induced Pluripotent Stem Cells Commercially confidential: Slide 22

  23. Collaborators • Wellcome Trust Funded- hESC Master Cell Bank Production and Manufacture of hESC derived red blood cells. • Neurostemcellrepair-hESC derived neural progenitor cells –Parkinson's disease • Repair – HD -hESC derived neural progenitor cells – Huntington's disease Confidential

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