SWITZERLAND EXPERTS TAKING CARE CORDEN PHARMA CordenPharma Switzerland Eichenweg 1 4410 Liestal Switzerland Phone +41 61 906 59 59 Fax +41 61 906 59 58 [email protected] www.cordenpharma.com
SwitzerlandEXPERTS TAKING CARE
CordenPhARmA
CordenPharma Switzerland Eichenweg 14410 LiestalSwitzerland
Phone +41 61 906 59 59Fax +41 61 906 59 58
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