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TRANSCRIPT
DSM Biologics
AusBioTech 2012 Melbourne October 31, 2012 Marc Goemans VP Global Marketing & Sales DSM Brings Mammalian cGMP Manufacturing to Australia
Agenda
• Introduction
• Brisbane
• How do we serve Australian clients?
Who We Are?
Page 4
Latin America: 15 locations 1,000 employees
North America: 33 locations 4,000 employees
Europe: 52 locations 6,800 employees
China: 24 locations 3,000 employees
India: 8 locations 700 employees
Around 200 locations across all continents
DSM Pharma Biotech
North America: Fill & Finish, NC HQ, NJ
Europe: Small Molecules Biologics BioSolutions
Australia Biologics
Japan: All products
All units FDA and EMEA approved
Page 6
DSM Biologics Facilities
Australia Brisbane
Europe Netherlands
DSM Biologics
A global provider of manufacturing technology and contract services to the biopharmaceutical industry
• Contract Manufacturing Services
– Cell Line Generation for all mammalian cell lines – Process Development – Phase I/II – Phase III/Commercial
• Fed batch 50, 250, 500, 1000, 2000 L single-use bioreactors • XD® 500 L (= 5000 L FB equivalent)
• Technologies
– CHO XL99 and PER.C6® cell lines – XD® High cell Density for titre amplification – RHOBUST® - 2nd generation EBA – others
Brisbane Facility Local Solution for Australian Biotech Companies
• 26 years experience in Mammalian Contract Manufacturing – Manufacturing sites in Groningen, Netherlands and Brisbane, Australia (as of 2013) – Biologics production - proteins, monoclonal antibodies – Proprietary/Patented technology and licensing
• XD® - intensifying upstream cell culture • RHOBUST® - direct capture purification step
– One-stop-shop • From development to clinical and commercial supply • Regulatory support and global reach
XD® and RHOBUST® are registered trademarks of DSM.
DSM Biologics – What we do
• Biologics manufacture - – Use of mammalian cell lines, genetically-modified to produce recombinant
therapeutic proteins. • USP – Cells grown in bioreactors for 2-4 weeks • DSP – Protein is purified and concentrated to final Drug Substance
– Operated under cGMP, our facility will be world-class and licensed by the TGA and OGTR.
• Use of dedicated air-handlers and cleanroom gowning, single-use systems, highly-trained technicians and a comprehensive Quality Management System.
DSM Biologics – What we do (cont’d)
New DSMB Brisbane Facility • Partnership between DSM and
BioPharmaceuticals Australia (BPA) – BPA established by Qld Government to
construct a manufacturing facility and identify an experienced international CMO partner
– DSMB selected to co-design and operate facility – Facility funding provided by Commonwealth of
Australia and Queensland governments
• Facility to offer 24/7 manufacturing – 6 levels (60x35m, 8000m2 total floor space) – Future expansion (fit out of levels 2/3)
• Project Schedule
– Internal Fit Out – Q3 2012 – Commissioning & Qualification – Q1/Q2 2013 – cGMP Manufacture - expected mid 2013
Level 1 – Warehouse & Plant Utilities
Warehouse
Plant Utilities
Level 4 – Manufacturing Area • Constructed clean room envelope– mobile equipment
– Purpose-built for material, personnel and process flow
Equipment Prep
Media / Buffer Transfer area
Media / Buffer Prep
Pre-Culture
Cell Culture (USP)
Primary DSP
Downstream Purification
(DSP)
Level 5 – Mezzanine Utilities • Utilities supporting level 4 – manufacturing area • Client viewing corridor
Trafficable Ceiling (Sandwich panel) Plant Space
(Bondeck slabs)
Level 5 – Client Viewing Corridor (Mezzanine) • View into cell culture and primary DSP suites
– Less disturbance to operations – Reduced safety and environmental risk to manufacturing area
Mock-up Design
Level 6 – Quality Control & Offices • Engineering, QC Laboratories, Offices and Administration
Quality Control Laboratories
Workshop
Administration/ Offices
How do we Serve Australian Clients?
Your Benefit
• A local approach
• Under DSM Biologics management • > 100 years of biofermentation experience • 25 years of experience in CMO with small Biotech/large Pharma
• Local service provider
– Close by & same time zone – International know-how – Access to innovative technologies – State-of-the-art Biologics Plant of the Future built for flexibility – Same currency – Eligible for R&D tax credit return schemes
Your Benefit
• XD® technology – DSM proprietary process technology – Increases cell density to 100 – 240 mln cells/mL – Increases titer 5 – 15 fold from same RCB – Process optimized to maximize Product Quality
• RHOBUST® technology
- DSM proprietary process technology for pharma - 3 steps in 1 – clarification to capture - Processes high cell density harvest
Reach out to us today – For your product to be on-time
XD®
