Large-scale Cell and Gene Therapy Catapult manufacturing facility for current
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1 Large-scale Cell and Gene Therapy Catapult manufacturing facility for current and future multiproduct processes October 2016
2 The Catapults Part of a world-leading network of technology and innovation centres Bridge the gap between businesses, academia, research and government Access technical facilities and expertise to help adopt, develop and exploit innovations Established by Innovate UK The Cell and Gene Therapy Catapult mission: Growing the UK cell and gene therapy industry, delivering health and wealth.
3 Cell and Gene Therapy Catapult Therapy industrialisation Process development Analytical development GMP process proving Supply chain Commercial-facing manufacturing Business Business development Business models Health economics Clinical trial and regulatory Regulatory Clinical trial sponsor Clinical operations Pre-clinical safety
4 Cell and Gene Therapy Catapult today 125m 125 million funding into the Catapult over 5 years 21.3m Invested 21.3 million in projects over the last three years 13m Invested more than 13 million in a state-of-the-art development facility 55m Investing 55 million in large-scale manufacturing centre in Stevenage 27.3m Leveraged 27.3 million of third party funding into businesses and projects in the last three years Three Formation of three spin out companies 30+ Over 30 live projects across our capabilities 120+ Over 120 cell and gene therapy experts from health economists and regulatory experts to leading edge translational scientists
5 Removing capital investment risk Investing in infrastructure
6 Cell and Gene Therapy Catapult 70m Development Facility 1,200m 2 Custom designed cell and gene therapy development facility Prime location in the heart of the London clinical research cluster 120 permanent staff 55m large scale manufacture center 7,200m 2 manufacturing centre designed specifically for cell and gene therapies Located in the Stevenage biocatalyst Opening 2017
7 State of the art laboratories in central London Replication of any process using configurable pod system Range of technologies to support upstream, bioreactor and downstream processing, fill and finish at commercial scale Technology transfer to full scale GMP Viral vector laboratory
8 CGT manufacturing centre
9 Why are we building a manufacturing centre? Market research Feedback from SME s and Large pharma Removing the capital investment risk for cell and gene therapy companies who need large-scale GMP manufacturing facilities. Collaborators will have control over their process within the facility. Your process. Your knowledge. Your success. Our support.
10 Large-scale GMP manufacturing facility Multi-collaborator facility 7,200m 2 footprint 12 x 100m 2 Grade B to C cleanrooms Centralised QC, warehouse, facilities management & waste disposal Enables companies to scale up manufacture Flexible - allogeneic, autologous or viral vector processes
11 Segregation at heart of design and operation Physical Architecturally segregated modules Technical corridors separate modules Walk on ceilings for plant access Single pass HVAC dedicated to each module Negative pressure sinks on all module entry and exit routes. Information Segregated data within BMS and EMS Hardwired & WiFi dedicated, secure Virtual Local Area Network.
12 People & material flow Unidirectional people flows Segregated product, material and waste flows
13 Flexible manufacturing Allogeneic and viral vector Autologous
14 Licensed facility CEO COO MHRA Licensed Facility Collaborator 1 Catapult in module QMS Product Specific MAA Catapult Quality Envelope Q Dir Collaborator 2 Own in module QMS Product Specific MAA Manufacture, Quality Control & Batch Release QP Manufacture, Quality Control & Batch Release Portable Tailored Quality Agreement Independent
15 UK Golden Triangle Consists of Oxford, Cambridge and London within the greater south east of England. Strongest biosciences cluster in Europe. Close proximity to strong academic base and a worldleading financial centre. The region is often seen as the gateway to Europe by large businesses. Consistent, secure, reliable, globally connected transport system. Oxford Cambridge Stevenage London
16 UK Cluster Cluster Engineering Support CGT Facility Specialist Couriers Equipment Suppliers Specialist Raw Material Suppliers LIMS EM Module Collaborator People Process Equipment Procurement QA/QC Facilities Management WMS QMS Skills Academy Sterile Fill Consumable Suppliers Clinical Trials
17 The Cell & Gene Therapy Manufacturing Centre Progress Investing in infrastructure
18 Accelerated timeline Collaborator Process Transfer starts First collaborators move in Collaborator process validation begins Q2 15 Q3 15 Q4 15 Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17 Q4 17 Facility design complete Planning permission granted Construction starts Facility envelope watertight Commissioning starts Facility validation starts Handover of building to CGT Manufacturing centre licensed
19 CGT manufacturing centre
20 CGT manufacturing centre (Sep 16)
21 CGT manufacturing centre: Ground floor (Sep 16)
22 CGT manufacturing centre; Cleanroom ceilings (Sep 16)
23 CGT manufacturing centre; CNC corridor (Sep 16)
24 CGT manufacturing centre; HVAC ductwork (Sep 16)
25 CGT manufacturing centre; Warehouse (Sep 16)
26 CGT manufacturing centre; Plant room (Sep 16)
27 CGT manufacturing centre; Office block (Sep 16)
28 In Conclusion Investing in infrastructure
29 World class expertise The Cell and Gene Therapy Catapult manufacturing centre is supported by a team of world-class experts, with end-toend knowledge to help collaborators commercialise their therapy. Health economics Regulatory support Clinical trial support Industrialisation Process development Assay development Tech transfer Manufacturing
30 For more information To find out more about collaborating with us in the manufacturing centre, please contact us: +44 (0) ct.catapult.org.uk To view a video of the manufacturing centre, visit our Youtube channel. To watch the development of the site in real time, visit our website.
31 Cell and Gene Therapy Catapult 12th Floor Tower Wing Guy s Hospital Great Maze Pond London SE1 9RT +44 (0) info@ct.catapult.org.uk ct.catapult.org.uk
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