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EXCLUSIVE SYNTHESIS TOLL MANUFACTURING CUSTOMER SERVICE INTERACTIVE PROJECT MANAGEMENT CUSTOM SYNTHESIS & API CONTRACT MANUFACTURING
EXCLUSIVE SYNTHESIS
TOLL MANUFACTURING
CUSTOMER SERVICE
INTERACTIVE PROJECTMANAGEMENT
CUSTOM SYNTHESIS& API CONTRACT MANUFACTURING
TOLL MANUFACTURING
• Pre-registered or marketed compounds• Technical transfer of existing process and analytical methods
EXCLUSIVE SYNTHESIS
• Molecules under clinical development: - From phase I to launch• Process Development offer for alternative synthetic route implementation: - Chemical and biotechnological development - Analytical development - Physical quality studies - Clinical supplies
PILOT PLANT PRODUCTION FROM TECHNICAL / ENGINEERING RUNS TO CLINICAL SUPPLIES
- Process Engineering and scale-up - Process safety
COMMERCIAL SUPPLY AT INDUSTRIAL SCALE
QUALITY & REGULATORY SUPPORT
CUSTOM SYNTHESIS & API CONTRACT MANUFACTURING UNDER cGMPFOR APIs OR MULTI-STEP INTERMEDIATES
Within the Industrial Affairs Division of Sanofi , CEPiA is an organization fully dedicated to third party activities. One of the key activities of CEPiA is to offer a broad range of innovative solutions including:• Intermediates and Active Pharmaceutical Ingredients (APIs) supply• Custom Synthesis & API Contract Manufacturing• Pharma Contract Manufacturing
CEPiA
CEPiA AT A GLANCE• 200 CEPiA collaborators close to customers• More than 200 APIs on catalogue…• … sold in 80 countries• API & Pharmaceutical CMO Services• 30 % of Chemistry and Biotechnology industrial activities of Sanofi
CEPiA guarantees REACH compliance.
• Oligosaccharides• Peptides• Oligonucleotides• Corticosteroids and Hormones• Prostaglandins• Opiates and opioids• Highly Active Products (HAP) • Multi-step heterocyclic chemistry
CHEMISTRY
• Plasmids• Therapeutic proteins (Production / Extraction / Purifi cation) - Extractive proteins - Recombinant proteins• Monoclonal antibodies
BIOTECHNOLOGY
EXPERTISE FIELDS
PROJECT IMPLEMENTATION
MARKET EVALUATION
SANOFI INDUSTRIAL CAPABILITIES & CAPACITIES
CUSTOMER VISITCONFIDENTIAL DISCLOSURE AGREEMENT (CDA)INITIAL DISCUSSIONS
NON-BINDING OFFER (NBO)PROCESS DEVELOPMENT & COMMERCIAL SUPPLY
AGREEMENT(S)LETTER OF INTENTPURCHASE ORDER
DEVELOPMENT SERVICE AGREEMENTMANUFACTURING & SUPPLY AGREEMENT
INQUIRY MANAGEMENTTECHNICAL PACKAGEREQUEST FOR PROPOSAL (RFP)
PRE-FEASIBILITY STUDY
DEVELOPMENT PLANINDUSTRIAL STRATEGY
COMMERCIAL SUPPLY
TECHNICAL TRANSFERVALIDATION
INDUSTRIAL PRODUCTION
COMPREHENSIVE CUSTOMER SERVICE
• Process development and commercial API production• Fully integrated offer including Drug Product and packaging INTERACTIVE PROJECT MANAGEMENT
• Project team with all relevant functions• Effi cient activities coordination (planning optimization)• Regular follow-up meetings to master operational and strategic project management
COLLABORATION BASED ON RESPECT
• Confi dentiality and Intellectual Property• Project timelines• Environment ➜ sustainable development (NYSE)• Ethical Chart• Sarbane-Oxley compliance
PROACTIVE SCIENTIFIC & COMMERCIAL RELATIONSHIP
• Proposals for potential improvements• Flexibility and responsiveness to customers’ needs RELIABLE & LONG-TERM PARTNERSHIP
CEPiA OFFERS
TIMEFRAMERFP NBO CONTRACT SIGNING PRODUCTION START
CDA NEGOTIATION
1 WEEK
COMMERCIAL SUPPLYTECHNICAL TRANSFER
4 - 8 MONTHS
CONTRACT NEGOTIATION
2 – 4 MONTHS
PRE-FEASIBILITY STUDY
4-6 WEEKS
CUSTOM SYNTHESIS & API CONTRACT MANUFACTURING
SCIENTIFIC & BUSINESS INTELLIGENCE Screenings & Evaluations Prospection support Market studies France-Emmanuelle THOLE [email protected] Tel: + 33 1 55 71 28 76
GLOBAL HEAD Tobias METZENTHIN [email protected] Tel: + 33 1 55 71 24 19
NORTH AMERICA Bob HUANG [email protected] Tel: + 1 908 981 6969 Alan BENSON [email protected] Tel: + 1 314 416 5156
Steroids Opiates Highly Active Products Small molecules Yannick LE STANC [email protected] Tel: + 33 1 55 71 26 38
Oligosaccharides Peptides Oligonucleotides Small molecules Mourad SAADY [email protected] Tel: + 33 1 55 71 20 81
EUROPE & ROW: CHEMISTRY
Monoclonal antibodies Plasmids Recombinant proteins Arnaud MARTIN [email protected] Tel: + 33 1 55 71 24 88
Extractive proteins Biocatalysis Biochemical derivatives Patrick CASTETS [email protected] Tel: + 33 1 55 71 26 39
EUROPE & ROW: BIOTECHNOLOGY JAPAN Hikaru OHSAWA [email protected] Tel: + 81 3 6301 3450 Chiho TADERA [email protected] Tel: +81 3 6301 3450
20, avenue Raymond Aron F-92165 Antony Cedex - France - Tel: +33 1 55 71 26 34Communication: Justine.doulcet-chabrol@sanofi .com | http://cepia.sanofi .com
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Our core competency is process development in chemistry and biotechnology. This involves:•Development,scale-upofAPIs andintermediatesprocesses fromroutescouting,laboratory developmenttokilolaband pilotplantscale•Technologytransfersof chemicalandbiotechnological processestoproduction•Optimizingcommercialprocesses throughcontinuous improvements•Respectofcostandtimelines
CEPiA’s strengths are:•High quality standards:excellent trackrecordwithHealthAuthorities•TechnicalexpertsincludingProcess Developmentandproductionsites•Patentsandlegalrepresentatives•QualityAssuranceand RegulatoryAffairssupport•Aglobal purchasing policyforan optimizedsupplychainofsolvents andrawmaterials•Security / reliabilityofsupply: possibilityofinternaldualsourcing•Financialstability
facilities and technologies
InduSTrIAl nETwOrk
SuSTAInAblE dEvElOPmEnT
CHEmISTry & bIOTECHnOlOgy
CHEmISTry
bIOCHEmISTry
bIOTECHnOlOgy
HEAdquArTErS
vErSATIlITy Of EquIPmEnT
EuropE focus
frankfurt
Ploërmel
vertolaye
mourenx
Elbeuf
ujpest
lyongaressio
Haverhill
Sisteron
Aramon
vitry
Antony
brindisi
CHEmISTry· Multi-purposeequipmentfrompilot-scaleto20m3
· Totalvolumereactor>4000m3
· Hydrogenations(upto200bar,upto18m3)· Temperaturerange(-120°Cto220°C)· Reactorsinstainlesssteel,glass-lined,hastelloy· Continuousreactionprocesses· Highvacuumproductdistillations(rectification/thin-film)· Largescalechromatography(reversephase/ionexchange)· Centrifuges,filter-dryers,stirredpressurefilters· FinishedprocessingofAPIs(milling,micronization, cleanroompackaging)· Examples of hazardous chemicals handled at industrial scale: oNaN3(azidation,tetrazoleformation) oMethylatingagents(CH3Clupto15bar,(CH3)2SO4) oStrongorganometallicbases(NaNH2,LiHMDS,BuLi) oCyanides(NaCN,KCN) oHydrazine(H2N-NH2) oIn situ generatedborane(BH3)
CHEmISTry· Syntheticalternativeroutescouting· Laboratoryinitialscreening· Scale-upfrom10mLto20Lreactors· Processoptimization· Definitionofoptimaloperatingproceduresandcriticalparameters
· Preparationofimpurities:fullsynthesisand/orisolation· Preparationofreferencestandards· Productionsupport: oProcessimprovement oTroubleshooting
bIOTECHnOlOgy· upstream process: oFermentersfrom10to200m3
oMammaliancellculture:400to10000L oPlasmids:dedicatedfacilitywith3500Lreactor· downstream process: oBiomassseparationbymembraneorcentrifuge
technology oExcellenceinviralsafety:pre-viral/postviralzoning oIndustrialchromatography(reversephase,ion
exchangediameter,upto1,4m) oFiltrationtechnologies:microfiltration,
ultrafiltrationandnanofiltration oEfficientnetworkingwithSanofiFillandFinish
plants(integratedoffer)
bIOTECHnOlOgy· upstream: oMicrobiologyandmolecularbiology oEnzymology oFermentation oMediaOptimization oCellengineeringandcellculture· downstream: oExtractionandfiltrations oRefolding oPrecipitationandcrystallization
state-of-the-art production facilities
chemistry & Biotechnology development
PrOCESS EngInEErIng· Thermalexchanges· Materialtransfers· Stirring· Scale-upandscale-downstudies· Extractionandseparation(Liquid/Liquid, Solid/Liquid)· Industrialchromatography· Modelization,equipmentdesignandpiloting· Processintensification
PHySICAl quAlITy· Crystallizationdesign(polymorph andmorphologyscreening)· Filtrationanddryingprocesses· Solidchain,milling,micronization· Powderpropertiesdetermination
PrOCESS SAfETy· Thermalanalysis· Powdersafety(granulometry,electrostatic propertiesexplosion)· Runawayreactor
EnvIrOnmEnTAl dATA· Biodegradabilityofeffluent· Ecotoxicity· Supporttowastewatertreatmentplants
PIlOT PlAnT bATCHES· Technicalbatches(engineering,scale-up)· Clinicalsupply· Primarystability· Registration(DMF)
AnAlyTICAl CAPAbIlITIES· Developmentandvalidationofanalyticalmethods· Structuralcharacterization· Impurityidentification,quantificationandtracking· Glycanmapping,peptidemapping,identification ofaggregates· Comparabilitystudies· Purityanalysis· Stabilitystudies· Traceanalysis(organicorinorganic)
quAlITy COnTrOl· In-Process-Controls(IPCs)· Testingofrawmaterials&APIs· Testingofstandardsandreferencematerials· Cleaningverificationandvalidation
quAlITy ASSurAnCE & rEgulATOry SuPPOrT
· cGMPcompliance· Regulatorysupportforfiling· Qualificationofsuppliers· Releaseofmaterials
CHEmISTry & bIOTECHnOlOgy
20,avenueRaymondAronF-92165AntonyCedex-France-Tel:+33155712634Communication:[email protected]|http://cepia.sanofi.com
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FROM INSULIN AND GROWTH HORMONETO BIOPHARMACEUTICAL CMO SERVICE
Fragments oF antibodies (Fabs)
Polyclonal antibodies
Plasmids anddna Vaccines
bacteria & yeasts
enzymes
Proteins
BIOPHARMACEUTICAL PRODUCTS (1 OF 2)MICROORGANISM FERMENTATION & ExTRACTION
HOECHST1923 Production of extractive insulin1936 crystallized insulin 1976 Production of semi-synthetic insulin
AvENTIS 1999 recombinant insulin from E.Coli fermentation (insuman®)2000 launch of lantus® 2004 launch of apidra®
SANOFI-AvENTIS 2005 routine production of recombinant urate oxidase2009 Purification of therapeutic proteins
SANOFI1984 recombinant hgh through E.Coli fermentation
GENzyME 1994 launch of cerezyme®
2001 launch of Fabrazyme®
2002 launch of aldurazyme®
2006 launch of myozyme®
From the 60’s, Sanofi has been a leader in the field of large-scale fermentation with the productionof vitamins, antibiotics and steroids. In the 80’s, the production of recombinant proteins and enzymes has been a pillar of growth for the company.Fighting against diabetes, sanofi has become a leader in recombinant processing through its biosynthetic insulin business.moreover, sanofi has built a large library of microorganisms and non-natural enzymes, in order to have access to the optimized complex molecules.
expertise available from 3 centers of excellence:Frankfurt (Germany): specialized in fermentation and downstream process (dsP)Aramon (France): specialized in dsP to process natural extracts, plants, and animal milkLyon-Gerland (France)-(former genzyme plant): skills and capacities to process blood derivatives (site purifies thymoglobulin from blood cells)
Continuous process and cost improvement using latest innovation (combining stainless steel and disposable equipment)
A broad range of services to achieve your success: •Biosafetyriskassessmentdonebyviralexperts•Fill&finishfacilitiestoofferone-stop-shop(liquidandlyophilizedvials,injectablesyringes)
Our upstream expertise covers:•Strainbuildingandoptimization (molecular biology team in Frankfurt- germany)•MastercellbankcGMPproduction and storage•Highdensityfermentationupto55m3
•Highthroughputcelldisruption techniques•Inclusionbodytechnology (processing, refolding)
Our downstream expertise covers:•Isolationtechniquesofabroad range of solutes and solids: continuous centrifugation, filtration, drying•Processscale-upusingin-house know-how and tools•Largescalelowtohighpressure
chromatographic techniques for the purification of proteins (glycosylated, multimeric)
PRODUCTION AND PURIFICATION OF THERAPEUTIC PROTEINS AND ENzyMES:FERMENTATION / PLANT ExTRACTION / ANIMAL ORIGIN
THERAPEUTIC PLASMIDS& DNA VACCINES
Sanofi has an unique expertise with creation, productionand purification of plasmids through in-house program.one compound completed international phase III studies:inds and imPds submitted and drug substance validation completed.
State-of-the-art workshop located in Frankfurt (germany)is equipped with several trains of fermentation up to3 500 l with associated downstream process (dsP).
Upstream process :•Cellbanking:mastercellbank, working cell bank•Highcelldensityfermentation
Downstream process :•Specificequipmentforcontinuous cell lysis•Expertiseinthepurificationof plasmids at large scale•Technologyavailablefor the affinity chromatography of plasmids
Specific technology andplasmid design:•SanofipatentedpCOR technology•Batchsize:30/40g•Highnumberofcopies•Noantibioticresistancegene•Insertionofmultimer resolution gene
Example of a plasmiddeveloped in-house:•DoublestrandedcircularDNA•Supercoiledform•Size:1.5millionDalton
CONTACTS
MICROORGANISM FERMENTATION & ExTRACTIONEurope: [email protected] [email protected]: [email protected]: [email protected]
Contract manufacturingservices offer:•cGMPbatchesfrom preclinical phase to commercial scale•Transferofcustomer’s process and analytical methods•Fill&finishfacilities•Specific analytical expertise (to characterize and release material)
20, avenue raymond aron F-92165 antony cedex - France - Tel: +33 1 55 71 26 34communication: [email protected] | http://cepia.sanofi.com
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In a worldwide competitive and fast evolving environment, start-up pharmaceutical and biotech companies need flexibility. Taking advantage of historical success, CEPiA offers to its customers a flexible and innovative solution to achieve success with their bio-logics projects, from development to commercialization.
Chimerization and humanization
mabLaunch™
Perfusion & fed-batChes
mabs
Cho CeLLs
interLeukins
bioPharmaCeutiCaL ProduCts (2 of 2)MAMMALIAN CELL CULTURE
Sanofi offers biomanufacturing services from clinical phases to commercial scale:•Expressionvectorconstruction•mAbchimerizationandhumanization•Celllinedevelopment•Biosafetyriskassessmentdonebyviralexperts•Stronganalyticalbackgroundwithsophisticatedglycosylatedproteins•Fullrangeofanalyticalandregulatorysupport•Fill&finishfacilitiestoofferone-stop-shop
Development and production of monoclonal antibodies and therapeutic proteins from two facilities.
CaPi organization (Frankfurt,Germany)fromearlyphaseto phase III:•66technicalexpertsfordevelopmentofmAbs processes and analytical for in-house and customers purpose•Perfusionandfed-batches•Disposableandstainlesssteelbioreactorsfrom20Lto2500L•Purificationcolumnfrom20cmto60cm•Significanttrackrecords•Successfultransferofprocessesandanalyticalmethods•Analyticalexpertisetocharacterizeproteins andreleasecGMPbatches
a fuLLY inteGrated orGanization to ProduCemonoCLonaL antibodies & theraPeutiC ProteinsFROM MAMMALIAN CELL CULTURE
bioLaunch organization co-located with Process Development (Vitry-sur-Seine,France):fromphaseIIItocommercialbatches•60scientistsandtechnicians•recentlybuiltstate-of-the-artfacilitydedicatedtomammalian cells bioproduction•3modularstainlesssteeltrains•2separateseedtrainsfrom100Lupto3000L•1bioreactorof2500Land3bioreactorsof10000Lbasedon fed-batch processing•broadrangeofassociateddownstreamprocess(DSP)to achieve purification of mAbs
additionally, Lfb biomanufacturing & sanofi have combined their bioproduction capabilities to provide integrated Cmo services for biopharmaceuticals (mabLaunch™, see specific brochure).
ContaCts
mammaLian CeLL CuLtureeurope: [email protected]: [email protected]: [email protected]
VItry-Sur-SEInE(FrAnCE)
mabs
20,avenueraymondAronF-92165AntonyCedex-France-tel:+33155712634Communication: [email protected] | http://cepia.sanofi.com
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VIRAL VECTORSFOR GENE THERAPY AND VACCINES APPLICATIONS
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Sanofi has been a pionneer in the fi eld of Gene therapy in the 80s’ through Gencell organization developping Viral Vectors. Sanofi through its vaccines division has a successfull history in virus production with launch of a large number of vaccines based on viruses.CEPiA offers its services to produce Viral Vectors through its Sanofi Pasteur and Genzyme divisions.
VIRAL VECTORS
MERIAL
SANOFI PASTEUR
GENE THERAPY
THERAPEUTIC VACCINES
GENCELL 1998
GENZYME
Sanofi team, with 20 years of experience, is a leading com-pany in the production of viral vaccines (wild type or recom-binant virus) and viral vectors.CEPiA offers a broad range of services such as, cell and virus banking, process scale up to commercial scale scale manufacturing with various technologies (static culture, dynamic culture in single use bioreactors up to 1000 L).Through Sanofi industrial network, CEPiA can provide Fill & Finish services.
Lyon (France) a cluster of excellence to support external partners’ projects:• Experts in Virology for vector
optimization• Upstream and downstream process
excellence based on mammalian cell culture (suspension and adherent cell line on microcarriers), viral culture for vaccines production
• Engineering teams worldwide,working in close cooperation with equipment manufacturers
• Global knowledge managementto implement the most recent technical innovations
• Analytical and regulatory services• Fill & Finish facilities
CONTACTS
Viral VectorsEurope: arnaud.martin@sanofi .comUSA: john.fulmer@sanofi .comJapan: hikaru.ohsawa@sanofi .com
Broad range of products upon request :- Adenovirus- Recombinant adeno-associated virus (rAAV)- Sendaï virus- Modifi ed Ankara virus (MVA)- Lentivirus The teams, located in Lyon (France), have a signifi cant track record and have a successfull and diversifi ed experience in process and analytical transfers.Sanofi Pasteur and Genzyme collaborate to established a seamless project management.
Clinical batches can be provided from Sanofi Pasteur’s site located in Marcy L’Etoile (Lyon, France).For the production of commercial batches, a new industrial platform in Lyon (France) combining expertise from Sanofi Pasteur and Genzyme will be operational in 2015.
20, avenue Raymond Aron F-92165 Antony Cedex - France - Tel: +33 1 55 71 42 82Communication: catherine.ortet@sanofi .com | www.cepia-sanofi .com
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PEPTIDES & OLIGONUCLEOTIDES
STATE-OF-THE-ART EQUIPMENT
SCIENTIFIC EXPERTISE
INNOVATIVE PLATFORM
LIQUID & SOLID PHASE CHEMISTRY
Our “TIDES” Platform is embedded in a unique state-of-the-art infrastruc-ture on one of the largest industrial chemistry & biotechnology sites in Frankfurt (Germany). CEPiA offers customized services (manufacturing and analytical) from clinical phase to submission and launch (grams scale up to kilo-grams quantities), including regula-tory support, as well as commercial supplies. On the same location, cGMP API manufacturing can be combined with Drug Product and Devices technologies.
Our facilities are regularly inspected by Health Authorities, including FDA, EMA and PMDA.
One of our current development is the oligonucleotide-peptide conju-gation.
• Liquid phase peptide synthesis and synthesis of intermediates (50 - 600 L)
• Solid phase peptide synthesis (10 - 280 L)
PEPTIDE DEVELOPMENT AND PRODUCTION
ProcessDevelopment
Pilot Synthesizer10-80 L
Clinical TrialQuantities
CommercialBatches
Chromatography300/350 mm
columns (lEx, RP)
Lyophilizers(10 Kg + 40 Kg ice)
Production Plant
Production Plant
Synthesizer 280 L
Production Plant
Chromatographyup to 1 400 mm
columns (lEx, RP)in industrial network
Lyophilizer(100 Kg ice)
Synthesis
Purifi cation
Isolation
Cleavage & Precipitaion
Solid Support/Resin
Resin + Peptide
Chromatography 1
Chromatography 2
Vacuum - Distillation
Lyophilization
Crude Peptide
Pure Peptide
Full analytical service: - Structural characterization - Development of analytical methods - QC testing for batch release - Full scope of analytical studies needed for fi ling
Solvent supply lines, storage areas and waste management are designed according to the latest European standards.
Through Sanofi ’s 25 years experience in the fi eld of oligonucleotides, CEPiA can provide different classes of Oligonucleotides such as DNA, 2’-O-Modifi ed, phosphorothioate derivatives.
Chromatographyup to 1 400 mm
in industrial network
Production Plant
Pilot Synthetizer up to 600 mmoles
scale of crude Oligonucleotide (“Oligo Process”
with 12 independent amidite ports)
LyophilizerIsolation
Purifi cation
Desalting &Concentration
Synthesis
Deprotection & Cleavage
Chromatography
Solid Support
Ultra-fi ltration
Oligonucleotide/Support
OligonucleotideSolution
Lyophilization
PureOligonucleotide
OLIGONUCLEOTIDE DEVELOPMENT AND PRODUCTION
CONTACTS
TIDESEurope: mourad.saady@sanofi .comUSA: Peptides alan.benson@sanofi .com Oligonucleotides baoguo.huang@sanofi .com Japan: hikaru.ohsawa@sanofi .com
INNOVATIVE PLATFORM
20, avenue Raymond Aron F-92165 Antony Cedex - France - Tel: +33 1 55 71 26 34Communication: Justine.doulcet-chabrol@sanofi .com | http://cepia.sanofi .com
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OligOsaccharides20 years expertise
200 chemical steps developed
synthetic heparinoïds
WorldWide leader
Sanofi has been involved in oligo-saccharide chemistry since the 90’s and is recognized as a world-wide leader in API manufacturing in this field.Amongst this family of very active anti-thrombotic derivatives, Sanofi developed and marketed semi-synthetic or fully synthetic hepari-noïds. For the fully synthetic oligosac-charides, Sanofi has developed complex molecules which manu-facture requires a high number of chemical steps (up to 80 chemical steps).
For the projects, we develop a sy-nergetic approach using a common building-blocks strategy based on our worldwide industrial network.Main advantages:• Minimizethenumberofchemical intermediates• Reduceleadtime• Increasesecurityofsupply• Optimizecostofgoods.
more than 200 chemical steps have been developed by our teams and more than 100 experts have been involved to ensure a high level of performance on this very specific chemistry being able to manage even at production scale:
•Activationofoligosaccharidesthroughout trichloroacetimidates, thioglycosides
•Couplingreactions(glycosylations): - stereoselective & stereospecific reactions -lowtemperature(downto-50°Catproduction scale) - anhydrous conditions (water contents below 10 ppm)
•Orthogonalprotection/deprotectionstrategy
•Specificexpertisesin: - azidation - hydrazine handling
in addition, our analytical department fully supports these development activities with:
•Chromatographytechniques(HPLC,GC,IC,CE)with specific detection for molecules without UV absorption
•Massspectrometry(Q-TOF,TOF,Ion-trap)andNMR (500MHzand300MHz)toelucidateverycomplex chemical structures
contacts
oligosaccharideseurope: [email protected]: [email protected]: [email protected]
laboratories for oligosaccharidesynthesis and analysis
•Kilolabfacilitiesforproductionofsmall scale batches to support phase I to phase III clinical studies
•Kiloprepfacilitiesfornormal,reverse phase chromatography: Prochrom systems(50to300mm)
•Pilotplantandproductionfacilities: from50Lto6000L
•Ionexchangededicatedpurification facilities from grams to kilograms of APIs
TOOls - facilities
WorldWide leader
20,avenueRaymondAronF-92165AntonyCedex-France-telf:+33155712634Communication:[email protected]|http://cepia.sanofi.com
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HigHly Active Products
Iso 7 classIfIcatIon
outstandIng facIlItIes
oeB 5 compounds
HIgHly skIlled teams
CEPiA offers to customers to have their Highly active product (HAP) projects handled by the same ex-perts who developed and manu-facture the two marketed drugs: Docetaxel (Taxotere®) and Cabazi-taxel (Jevtana®)
We are committed to sharing our scientific knowledge and experience in pharmacology and toxicology to support your project.
Our internal team of experts in industrial hygiene can assess OEB* categorization for APIs and upstream intermediates only when necessary to minimize costs. We apply the OEB* index from 1 to 5 relative to the product toxicity. OEB* index corresponds to an OEL** range (see the following table).
our high level of expertise acquired through solid and long lasting experience in handling cytotoxic compounds is strongly set on four principles:
*OEB: Occupational Exposure Brand**OEL: Occupational Exposure Level
oeB* OEL** Range (µg/m3)
oeB 1 1 000 - 5 000
oeB 2 100 - 1 000
oeB 3 10 - 100
oeB 4 1 - 10
oeB 5 < 1
• Extensive knowledge in Chemistry
• State-of-the-art facilities
• Highly trained team
• Environment, Health and Safety experts
our facilities for highly active compounds manufacturing are located near paris (france), operated under cgmp procedures and are governed by sanofi Quality control. On the same site, two production units are suitable for technical transfer and process development, small scale production and large industrial scale manufacturing. These two units are operated in ISO 7 classification for OEB 4 and OEB 5 compounds and are regularly inspected by Health Authorities, including FDA,EMA & PMDA.
All the production lines are equipped with the latest technologies in isolators, glove boxes, vessels and drying equipment. Machinery is fully or partially segregated with air control systems satisfying the most stringent requirements for product and personnel protection.
Our volume range is 5 - 1 000 L reactors in stainless steel, hastelloy and glass-lined for a total of 39 reactors (total volume of 10 m3). Upon request, we provide milling and micronization services for HAP in ISO 7 room. The total staff is nearly 80, working in one or two shifts. Highly trained personnel are recognized for their ability to work meticulously and safely in contained environment.
contacts
Hapeurope: [email protected]: [email protected]: [email protected]
HIgHly skIlled teams
20, avenue Raymond Aron F-92165 Antony Cedex - France - tel: +33 1 55 71 26 34Communication: [email protected] | http://cepia.sanofi.com
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