DSM Biologics


DSM Biologics

DSM BiologicsAusBioTech 2012MelbourneOctober 31, 2012Marc GoemansVP Global Marketing & SalesDSM Brings Mammalian cGMP Manufacturing toAustralia

Agenda• Introduction• Brisbane• How do we serve Australian clients?

Who We Are?

Page 4Around 200 locations across all continentsNorth America:33 locations4,000 employeesChina:24 locations3,000 employeesEurope:52 locations6,800 employeesIndia:8 locations700 employeesLatin America:15 locations1,000 employees

DSM Pharma BiotechNorth America:Fill & Finish, NCHQ, NJJapan:All productsEurope:Small MoleculesBiologicsBioSolutionsAustraliaBiologicsAll units FDA and EMEA approved

Page 6DSM Biologics FacilitiesEuropeNetherlandsAustraliaBrisbane

DSM BiologicsA global provider of manufacturing technology and contract services tothe 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 ® - 2 nd generation EBA– others

Brisbane FacilityLocal Solution for Australian BiotechCompanies

DSM Biologics – What we do• 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 commercialsupply• Regulatory support and global reachXD® and RHOBUST® are registered trademarks of DSM.

DSM Biologics – What we do (cont’d)• Biologics manufacture -– Use of mammalian cell lines, genetically-modified to produce recombinanttherapeutic 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 TGAand OGTR.• Use of dedicated air-handlers and cleanroom gowning, single-use systems,highly-trained technicians and a comprehensive Quality ManagementSystem.

New DSMB Brisbane Facility• Partnership between DSM andBioPharmaceuticals Australia (BPA)– BPA established by Qld Government toconstruct a manufacturing facility and identifyan experienced international CMO partner– DSMB selected to co-design and operate facility– Facility funding provided by Commonwealth ofAustralia and Queensland governments• Facility to offer 24/7 manufacturing– 6 levels (60x35m, 8000m 2 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 UtilitiesWarehousePlant Utilities

Level 4 – Manufacturing Area• Constructed clean room envelope– mobile equipment– Purpose-built for material, personnel and process flowEquipmentPrepMedia /Buffer PrepMedia / Buffer Transfer areaDownstreamPurification(DSP)PrimaryDSPCell Culture(USP)Pre-Culture

Level 5 – Mezzanine Utilities• Utilities supporting level 4 – manufacturing area• Client viewing corridorPlant Space(Bondeck slabs)Trafficable Ceiling(Sandwich panel)

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 areaMock-up Design

Level 6 – Quality Control & Offices• Engineering, QC Laboratories, Offices and AdministrationQuality ControlLaboratoriesAdministration/OfficesWorkshop

How do we ServeAustralian 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 QualityXD ®• RHOBUST ® technology- DSM proprietary process technology for pharma- 3 steps in 1 – clarification to capture- Processes high cell density harvestReach out to us today – For your product to be on-time

Thank youQuestions?Or contactTertia.dex@dsm.comMarc.Goemans@dsm.com

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