CordenPhARmA Switzerland...cGMP manufacturing facility with over 25 years of experience in the...

SwitzerlandEXPERTS TAKING CARE

CordenPhARmA

CordenPharma Switzerland Eichenweg 14410 LiestalSwitzerland

Phone +41 61 906 59 59Fax +41 61 906 59 58

sales@cordenpharma.com

www.cordenpharma.com

Our History• 1987-FoundedasSygenaAGfocusingonlipidandaminoacidchemistry

• 1994-GenzymeCorporationacquiredSygenaAGfortheGMPmanufactureof APIsandhigh-valuepharmaceuticalexcipients

• 1999-SygenaofficiallychangeditsnametoGenzymePharmaceuticals

• 2011-GenzymePharmaceuticalsacquiredbyICIGtobecomeCordenPharmaSwitzerland

Cordenpharma SwitzerlandCordenPharmaSwitzerland,locatedinLiestalnearBasel,isacGMPmanufacturingfacilitywithover25yearsof experienceintheproductionof pharmaceuticalingredientsincludingsyntheticlipids,peptides,carbohydratesand

othercomplexsmallmolecules.CordenPharmaSwitzerlandisadditionallyanindustry-recognizedleaderinthemanufacturingof aminoacidderivativesandpseudoprolinedipeptidessuitablefortheGMPproductionof

peptideAPIs.CordenPharmaSwitzerland’s chemists are experts indevelopingandprovidingscalableprocesses,analyticalcontrolsandfullDMF/IND/IMPDsupportforthemanufactureof complexmolecules.

> 25 Years of Experience

Your Cmo partner

us Compliance Worldwide•cGMP certification -

API manufacturing and Analytical Testing

•US-FDA – 2000, 2004, 2007, 2011

•Swissmedic – bi-annually - most

recently April 2011, April 2013

•Numerous customers from all over the world

Core CapabilitieS•SyntheticPhospholipids•Peptides•Conjugates•Carbohydrates•SmallMolecules•ProprietaryBuildingBlocks(smallpack) -SyntheticPhospholipids -AADs -PseudoprolineDipeptides

what we do Custom manufacturingof apis

Lipids, Peptides & Carbohydrates

CordenPharmaSwitzerlandistheleaderintheproductionof fullysyntheticglyceroandsphingolipids,whicharehighlypurifiedsinglecompoundsproducedinbulkquantitieswithconsistentbatch-to-batchquality.UsedascriticalformulationexcipientsandAPIsinanumberof approvedparenteralsandpulmonarydeliveredtherapeutics,ourlipidsareavailableinsmallquantitiesforResearch&Development.CordenPharmaSwitzerlandisalsoapreferredpartnerforthecustommanufactureof cationiclipidsusedinliposomaldeliveryof oligonucleotide-basedactiveingredients.

Ourcorecompetenciesfurthermoreincludesolution-phaseand/orsolid-phasepeptidechemistry.Within-housedevelopmentandmulti-tonproductioncapabilitiesforchiralbuildingblocks,unusualandnaturalaminoacidderivatives,ourcost-effectivepeptideAPImanufacturingensuresthebestpossiblecontrolof supplychainandregulatoryrequirements.Inaddition,wepioneeredtheproductionanduseof pseudoprolinedipeptidesbuildingblocks,whicharepowerfultoolsforbypassingchallengesassociatedwiththesynthesisof “difficultsequences”and long peptides.

CordenPharmaSwitzerlandhasadditionallydevelopedexpertiseintheefficientmanufactureof carbohydrates(mono-andoligosaccharidebuildingblocksandchemically-definedglycans)onamulti-kgscale.Combinedwithourstrongexpertiseinfully-syntheticlipid,peptideandaminoacidchemistry,CordenPharmaSwitzerlandisuniquelypositionedtomanufactureglycoconjugatessuchasglycosylamino-acids,glycopeptidesorglycolipids.

OurSwissfacilitymaintainsanindependentQualityAssurancegroupandQualityControllaboratories,ensuringseamlesscustomersupportincriticaldevelopmentareassuchasanalyticaldevelopment&validation,cleaningmethoddevelopment&validation,stabilitystudiesandthefilingandmaintenanceof documentationsuchasUS-DMFs,EDMFsandothers.

we serve an expansive global customer base from start-up to large biotech or pharma with complex development and commercial products, r&d samples and reference standards in various stages.

teChnologieS / proCeSSeS Inadditiontolipid,peptideandcarbohydratechemistry,CordenPharmaSwitzerlandhasprovenscale-upexperienceinabroadrangeof chemicaltransformationsincludingbutnotlimitedto:

•Acetylation

•Acylation

•Enantioselectivesynthesis

•CatalyticHydrogenation(homogeneous,heterogeneous)

•SuzukiCoupling

•SharplessEpoxidation

•Grignardreaction

•Mitsunobureaction

•Organometallicreactions

•Phosphorylation

•Polymerisation

•Oxidation(Swern/Tempo)

•Wittigreaction

equipment detailSEquipment for pilot batches and commercial production

•Kilo-labsuitesforsmall-scalecGMPrequirements

•Equipmentcapacityrangingfrom20to160L

•Reactorsuites

-Reactorcapacity:60to2500L

-Temperaturerange:-90°Cto160°C

•Dryingsuites

-Conicaldryer

-Vacuumtraydryers

•Milling/Screeningsuite

•Large-scalechromatography

Specialized Purification & Isolation Equipment

•PreparativeHPLCequipment(reversedphase;normalphase)

•Lyophilization

CapaCitieSReaction vessels (multi-purpose and dedicated equipment)

•Pilotplantforkg-scale

•cGMPproductioninvesselvolumesrangingfrom20Lto2500L

CmC developmentcGMP Manufacture

•Experiencedprojectmanagersforseamlesstechnologytransfer,routescoutingandprocessdevelopmentforexclusiveNCEs,excipientsandhigh-valueintermediates

•Manufacturingprocessvalidationstudies

•Clinicaltrialandcommercialmaterialsupply

Analytical Support

•Analyticalmethoddevelopmentandvalidationforin-processandreleasetesting

•Impurityprofilecharacterization

•Referencestandardproduction,qualificationandsupplytocustomers

•Cleaningmethoddevelopment&validation

Quality & Regulatory Support

•StabilitytestingaccordingtoICHguidelines

•Forceddegradationstudies

•Filingandmaintenanceof US-DMFs,EDMFsandothers

•Authoringof responsedossierstoauthorities