advanced therapy manufacturing and automation … 5 april 2017 media release advanced therapy...

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1 5 April 2017 MEDIA RELEASE Advanced therapy manufacturing and automation experts, Scinogy, join CTM CRC to accelerate development of next gen cell therapy manufacturing Advanced therapy manufacturing technology and scale-up specialists, Scinogy have joined the CRC for Cell Therapy Manufacturing (CTM CRC). The addition of Scinogy’s experience in manufacturing systems for cell therapy, complements CTM CRC’s expertise in surface functionalisation and new materials technologies. This powerful combination of capabilities will better address current manufacturing challenges, such as scalability and cost. “With the clinical progress and rapid growth in advanced therapies, the time is right to address the challenges facing commercial success. As processes for the manufacture of these products are locked in at a very early stage of development, early adoption of technologies that are scalable, reproducible, transferable and commercially viable is critically important. Integration of CTM CRC’s surface optimisation with Scinogy’s automated closed systems will provide a powerful tool towards more cost effective and scalable approaches to manufacturing.” Dr Sherry Kothari, CEO of CTM CRC, said. Advanced therapy companies must have confidence in their clinical data and products. Process integrity ensures that the same process has been performed for every patient, every batch, every site, every time. “The combination of Scinogy’s expertise in the development of closed, automated manufacturing systems and single-use kits in addition to CTM CRC’s surface functionalisation capabilities, provides an ideal opportunity to create next gen manufacturing processes that are reproducible, scalable and cost effective from the outset,” Mr David James, CEO of Scinogy, said. The collaboration between the two companies will begin with a focus on T cells, initially tailored to simplify Chimeric Antigen Receptor T cell (CAR-T) manufacture, currently of interest in the field for the development of immunotherapies for the treatment of cancer. A significant advantage of the Scinogy/CTM CRC collaboration is that both companies are developing platform technologies, which can be adapted to provide flexible, configurable systems, tailored to suit different processes for a range of cell types.

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Page 1: Advanced therapy manufacturing and automation … 5 April 2017 MEDIA RELEASE Advanced therapy manufacturing and automation experts, Scinogy, join CTM CRC to accelerate development

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5April2017 MEDIARELEASEAdvancedtherapymanufacturingandautomationexperts,Scinogy,joinCTMCRCtoacceleratedevelopmentofnextgencelltherapymanufacturingAdvancedtherapymanufacturingtechnologyandscale-upspecialists,ScinogyhavejoinedtheCRCforCellTherapyManufacturing(CTMCRC).TheadditionofScinogy’sexperienceinmanufacturingsystemsforcelltherapy,complementsCTMCRC’sexpertiseinsurfacefunctionalisationandnewmaterialstechnologies.Thispowerfulcombinationofcapabilitieswillbetteraddresscurrentmanufacturingchallenges,suchasscalabilityandcost.“Withtheclinicalprogressandrapidgrowthinadvancedtherapies,thetimeisrighttoaddressthechallengesfacingcommercialsuccess.Asprocessesforthemanufactureoftheseproductsarelockedinataveryearlystageofdevelopment,earlyadoptionoftechnologiesthatarescalable,reproducible,transferableandcommerciallyviableiscriticallyimportant.IntegrationofCTMCRC’ssurfaceoptimisationwithScinogy’sautomatedclosedsystemswillprovideapowerfultooltowardsmorecosteffectiveandscalableapproachestomanufacturing.”DrSherryKothari,CEOofCTMCRC,said.Advancedtherapycompaniesmusthaveconfidenceintheirclinicaldataandproducts.Processintegrityensuresthatthesameprocesshasbeenperformedforeverypatient,everybatch,everysite,everytime.“ThecombinationofScinogy’sexpertiseinthedevelopmentofclosed,automatedmanufacturingsystemsandsingle-usekitsinadditiontoCTMCRC’ssurfacefunctionalisationcapabilities,providesanidealopportunitytocreatenextgenmanufacturingprocessesthatarereproducible,scalableandcosteffectivefromtheoutset,”MrDavidJames,CEOofScinogy,said.ThecollaborationbetweenthetwocompanieswillbeginwithafocusonTcells,initiallytailoredtosimplifyChimericAntigenReceptorTcell(CAR-T)manufacture,currentlyofinterestinthefieldforthedevelopmentofimmunotherapiesforthetreatmentofcancer.AsignificantadvantageoftheScinogy/CTMCRCcollaborationisthatbothcompaniesaredevelopingplatformtechnologies,whichcanbeadaptedtoprovideflexible,configurablesystems,tailoredtosuitdifferentprocessesforarangeofcelltypes.

Page 2: Advanced therapy manufacturing and automation … 5 April 2017 MEDIA RELEASE Advanced therapy manufacturing and automation experts, Scinogy, join CTM CRC to accelerate development

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ThisisanexcitingtimefortheindustryandtheCTMCRC/Scinogypartnership,anddovetailswithCTMCRC’snewtranslationalfacility,TekCyte,fortheseamlessandefficientscaleupofmanufacturingprocessesfromthelabtocommercialscale.ThisalsoprovidesanopportunitytoestablishauniquecelltherapycapabilityinAustralia.

-Ends-AboutScinogyScinogyspecialisesinthedevelopmentofautomationandsingle-use-kitsforthemanufactureofadvancedtherapies.Scinogy’shighperformanceteamcombinesgreatscience,therighttechnologyandcommercialexperiencetohelpmakeyourclinicalresultsacommercialreality.AbouttheCRCforCellTherapyManufacturingCelltherapy,theuseoflivingcellstorepair,replaceorregeneratediseasedordamagedtissueistransforminghealthcareparadigmsglobally.Throughinterventionwithnovelcoatingsandsmartmaterialstechnologies,theCRCforCellTherapyManufacturingwillintroduceefficienciesincelltherapymanufacturingprocesses,suchascellisolation,expansionanddelivery.This,inturn,willdecreasecostsassociatedwithmanufacturingandfacilitatetherapidtranslationofcelltherapiesintoclinicalpractice.TheCRChasavisiontoincreasetheaccessibility,affordabilityandefficacyofcelltherapiesforpreviouslyincurable,ordifficulttotreatconditionssuchastype1diabetes,chronicwoundsandimmune-mediateddiseases.

Forfurtherinformationandmediaenquiriescontact:

NatalieWatkinsMarketing&CommunicationsManager

CRCforCellTherapyManufacturing+61883023917

[email protected]