BIONEEDS

Outstandingcustomerservicesandcommitmenttoscientificexcellenceandqualitythroughbestinclassservices Conformancetoglobalregulatorynorms(USFDA,EPA,OECD,EEC,MAFF,EMEA,MHRA,ANVISA,DCGI,CIBRC,RCGM) Bestinindustryteamleadsandtalentpoolwithextensiveindustryexperienceanddomainexpertise Worldclassinfrastructurewithcuttingedgetechnology InternationallyacclaimedContractResearchOrganization

MedicalDevicesCosmetics/TopicalDrugs(AlternativestoAnimalStudies)

AgrochemicalsPharmaceuticals

BiopharmaceuticalsNutraceuticals/Herbals VeterinaryDrugs

DrugTesting

BIONEEDSINDIAPRIVATELIMITEDisaBangalorebasedContractResearchOrganization,providingIntegratedDiscovery,Development&RegulatoryServicestoPharmaceutical,Biopharmaceutical,Agrochemical,Industrialchemical,Herbal/Nutraceutical&Medicaldevicecompanies. STATE­OF­THE­ARTFACILITIES Cuttingedgedrugdiscovery&developmentlabstosupportbiology,Invivopharmacology,pharmacokinetics,toxicology,medicinalchemistry,customsynthesis,processR&D,cGMPmanufacturing,formulation&analyticaldevelopmentservices Best­in­classinfrastructureina2,50,000sq.ft.built­upareaequippedwithstate­of­the­artfacilities Vivariumwith85exclusiveanimalroomsbuiltasperinternationalstandards

NationalGLPComplianceMonitoringAuthority(NGCMA),Dept.ofScienceandTechnology,GovernmentofIndia CommitteeforthePurposeofControlandSupervisionofExperimentsonAnimals(CPCSEA),MinistryofEnvironment,ForestsandClimateChange,GOI. StateDrugControllerasaGovernmentapprovedDrugTestingLaboratoryforcarryingouttestsonDrugs/CosmeticsandRawMaterialsusedinmanufactureonbehalfoflicenseesformanufactureandforsaleofDrugs/Cosmetics ReviewCommitteeonGeneticManipulation(RCGM),departmentofbiotechnology,GOItoconductexperimentsonanimalsforDNAorGeneticallymodifiedresources AssociationforAssessmentandAccreditationofLaboratoryAnimalCare(AAALAC) R&DunitrecognizedbyDepartmentofScientific&IndustrialResearch(DSIR) USFDAauditedlaboratorywithno483 ISO17025AccreditationfromNABL(NationalAccreditationBoardforTestingandCalibrationLaboratories)forBiologicalandChemicalTesting ApprovedbyCIB&RC(CentralInsecticidesBoard&RegistrationCommittee)GovernmentofIndia

INTEGRATEDDISCOVERY,DEVELOPMENTANDREGULATORYSERVICESBIONEEDS COSMETICS/TOPICALDRUGS(ALTERNATIVESTOANIMALSTUDIES)

BIOLOGICS/BIOSIMILARS/BIOPHARMACEUTICALS/VACCINESAGROCHEMICALS/INDUSTRIALCHEMICALS

PHARMACEUTICALS/HERBALS/NUTRACEUTICALS/VETERINARYDRUGS

MEDICALDEVICES

ABOUTUS

ACCREDITATIONS/CERTIFICATIONS

Telephone:+91816­2214400|Mobileno.:+919844457677

BIONEEDS SERVICES CAPABILITIES / PHARMACEUTICALS HERBALS/ /NUTRACEUTICALSOECDFDAICHScheduleY

VACCINES

Pyrogens Physicochemical Endotoxins AbnormalToxicity Sterility DoseStability EfficacyTest BatchReleaseTest Immunogenicity Toxicology PotencyTesting

ScheduleYJP,OECDWHOIP,BPEP,USP

NewChemicalEntities(NCEs) HeterocyclicBuildingBlocks&Scaffolds ComplexMolecules&Prodrugs KeyRawMaterials,AdvancedIntermediatesetc. Impurities&StableMetabolites– LibrarySynthesis

MedicinalChemistry:

DrugDevelopment: ProcessDevelopment&OptimizationofNCEs FormsSelection MaterialGenerationasRequiredforPre­clinical(non­clinical)Studies Phys­ChemStudies MethodDevelopment&Validation

OrganicVolatileImpurities,ResidualSolventsasperUSP/EP

GenerationofHits&TransformingHitsintoLeads Leadoptimization&SupportforDrugCandidateNomination LibrarySynthesisCustomSynthesis:(Frommgtomultikgscale)

SupportinIdentification&Characterization Preparation/Isolation,Qualification&Supply

ProcessResearch: ExpertiseinQualityProcessResearchforAPIs(ActivePharmaIngredients)&AIs(ActiveIngredients) StabilityStudies

Working/ReferenceStandard–Preparation,Qualification&Supply

QualificationofStandards RouteScouting,Non­infringingProcessDevelopment PatentableNovelProcessDevelopment ProcessImprovementProjects(CostReductionProjects)

ForcedDegradation

DossierPreparation&TechnologyTransferAnalyticalServices: RawMaterialCharacterizationasperlatestPharmacopoeia(USP/BP/EP/IP/JP) MethodDevelopment&ValidationasperICHGuidelines ImpurityProfiling:Methoddevelopment,Identification,Isolation,Characterization QualificationofStandards:Preparation,Characterization&EstablishingMassbyAssay(PotencyDetermination)

CHEMISTRYSERVICES Physicochemical AnalyticalChemistry FiveBatchAnalysis(ImpurityProfile) Toxicology Ecotoxicology GeneticToxicology SixPackToxicityStudies BioassayforBiopesticides REACHServices

AGROCHEMICALS/INDUSTRIAL CHEMICALS

BIOLOGICS BIOSIMILARS/ /BIOPHARMACEUTICALS CustomAssayDevelopmentServices Biologics/Biosimilars/BiopharmaCMCSupportAssays BioanalyticalServices(PK/TK/Immunogenicity/InvitroAssays) FinalProductCharacterization AntibodyProduction,Purification,Labeling&Characterization HostCellContamination Efficacy 1D/2DGelElectrophoresis Toxicology EMEAFDARCGMScheduleY

InvitroDermalPercutaneousAbsorptionStudies/IVPT Invitro3T3NRUPhototoxicityTest InvitroSkinCorrosionTest IsolatedChickenEye(ICE)Test InvitroPhototoxicityTest BovineCornealOpacity&PermeabilityTest(BCOP)

InvitroSkinIrritation&OcularIrritationStudies DirectPeptideReactivityAssay(DPRA) LocalLymphNodeAssay–LLNA(BrdU­ELISAMethod)

ALTERNATIVESTOANIMALSTUDIESFORTESTINGCOSMETICS,TOPICALDRUGS&CHEMICALSUBSTANCES

OPPTSCIPACCIBRCEPAOECD

InsulinAssays RabbitPyrogenTesting HumanChorionicGonadotropin EstrogenicActivity Follitropin,ResidualLHActivity Erythropoietin(EPO) Menotropin­FSH/LHActivity

EndotoxinTesting

TestforHistamine SpecificActivities ImmunogenicityTests(forHIVAntigens,HepatitisAntigensetc) EfficacyofAntimicrobialPreservation AbnormalToxicity SterilityTests TestforMicrobialContamination MicrobiologicalAssayofAntibiotics

BIOASSAYSUSPIPBPEPJP

MEDICAL DEVICES Genotoxicity ImplantationStudies HemocompatibilityTest SkinSensitization Irritation/IntracutaneousReactivity SystemicToxicity Biocompatibility Cytotoxicity BiologicalRiskAssessment

USFDAISO10993ASTM

ADMEPK/Invivo&Invitro ProofofConcept Efficacy Toxicology BatchReleaseTesting PhysicochemicalNumerousStudiesConducted&SuccessfullySubmittedtoDifferentRegulatoryAgencies

IMPURITY QUALIFICATION

Email:bioneeds@bioneeds.in

INHALATIONTOXICOLOGYSERVICES

PhysicalState Odour FlashPoint StorageStability Color Miscibility CorrosionTest Density Viscosity MeltingPoint BoilingPoint Flammability SelfIgnition AutoIgnition

pH PartitionCo­efficient ParticleSize Hydrolysis DissociationConstant ThermalStability SurfaceTension Absorption&Desorption Solubility EmulsionStability VaporPressure ExplosiveProperties Oxidizingproperties

PHYSICALCHEMISTRY

ACUTETOXICITYBIOLOGICALTESTS

AntibodyProduction,Purification,Labeling&Characterization Purity SDSPAGE

NeutralizingAntibodyAssays MonoclonalAntibodyProduction FinalProductCharacterization

HostCellDNA&HostCellProtein BiologicalActivity/Potency(Invitro/Invivo/Exvivo) Quantification(Colorimetric/UV280) ProcessRelatedContaminants/ImpurityCarryOverDetermination Endotoxin(Qualitative&Quantitative) pH(Liquidsamples) MycoplasmaDetection/Quantification Biologic/Bio­similar/BiopharmaCMCSupportAssays BioanalyticalServices(PK/TK/Immunogenicity/InvitroAssaysforBiologics/Biosimilars&BiopharmaProducts) CellProliferationAssays

AcuteOral/Dermal/IV/IM/SC/IP/Ocular AcuteInhalation AcuteDermalIrritation/Corrosion AcuteEyeIrritation/Corrosion AcuteInfusionStudies SkinSensitizationbyGPMT

ROUTESOFADMINISTRATION Oral Inhalation Intravenous Ocular Dermal Intradermal Intramuscular Intranasal Intraperitoneal Intraocular Intravitreal Intracorneal Subcutaneous Intratracheal Infusion

IMMUNOTOXICOLOGY LocalLymphNodeAssay ImmunoHistochemistry VaccinePotencyTest ClosedPatchTest

SUBCHRONIC&CHRONICTOXICITY 90DaysRepeatedDoseStudies 180Days&aboveChronicToxicityStudies/CombinedChronic&CarcinogenicityStudies CarcinogenicityStudies NeurotoxicityStudies RepeatedDoseInfusionStudies JuvenileToxicityREPRODUCTION&DEVELOPMENTALTOXICITY PrenatalDevelopmentalToxicity 1/2GenerationReproductionToxicity CombinedReproduction/DevelopmentalToxicity SegI,II&IIIStudies DevelopmentalNeurotoxicity HershbergerBioassay UterotrophicBioassay ExtendedOne­GenerationReproductiveToxicityStudyGENETICTOXICITY BacterialReverseMutationTest(AMES) InvitroChromosomeAberrationTest InvivoBoneMarrowChromosomeAberrationTest InvitroMammalianCellMicronucleusTest MammalianGeneMutationTest(HPRT/MouseLymphoma) MammalianErythrocyteMicronucleusTest CometAssay

SUBACUTETOXICITY 7/14DaysDoseRangeFindingStudy 14/28DaysRepeatedDoseStudies

ENDOCRINESCREENING HershbergerBioassay UterotrophicBioassay

E­FATE&RESIDUE Residue&Persistence DirectPhotolysis Hydrolysis Carbon/NitrogenTransformation Biodegradability ActivatedSludgeRespirationInhibitionTest AerobicandAnaerobicTransformationinSoil

ECOTOXICITYAquaticEcotoxicology

TerrestrialEcotoxicology

FreshwaterAlga&Cyanobacteria,GrowthInhibitionTest DaphniaAcuteImmobilizationToxicityStudy DaphniaMagnaReproductionTest AcuteFishToxicityStudy Fish,Early­LifeStageToxicityTest ChironomousAcuteImmobilizationTest MicrobialPesticideTest LemnaToxicityStudy Water­SedimentMyriophyllumSpicatumToxicityTest

LaboratorytestassessmentofplantProtectionProductsinnon­targetarthropods CollembolanReproductionTest

AcuteDelayedNeurotoxicityStudies AcuteOralToxicityStudyInHoneybees EarthwormReproductionTest AcuteToxicityStudyInEarthworm AcuteContactToxicityStudyInHoneybees AvianAcuteOralToxicityStudy

Predatorymite(Hypoaspis(Geolaelaps)aculeifer)reproductiontestinsoil

TerrestrialPlantTest:VegetativeVigourTest TerrestrialPlantTest:SeedlingEmergenceandSeedlingGrowthTest SilkWormAcuteToxicityTest TrichogrammaToxicityTest AvianAcuteDietaryToxicityStudy

PRECLINICALSERVICES

Inhalationtoxicologystudiesareperformedforpharmaceutical,agrochemical,chemical&consumerproductsindustries.FacilityisdesignedtoprovideGLPstudiesinaccordancewithtestingguidelinesoftheFDA,EPA&otherregulatoryagencies. Acutestudyforagrochemicals/industrialchemicals(ECB.2.,OECD403,OPPTS870.1300,CIBRC) Repeateddose(28/90days)studiesforpharmaceuticals(ScheduleY) Repeateddose(28/90days)studiesforagrochemicals(OECD412,OECD413) Acutestudyforpharmaceuticals

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ANALYTICALPRECLINICALSERVICES E­FateStudies AnalyticalMethodDevelopment&Validation ResidueStudies

PhysicochemicalProperties ActiveIngredientContent(Purity) FiveBatchAnalysis(ImpurityProfile) StorageStabilityStudies AnalyticalServicestoSupportToxicologicalStudies(e.g.,DoseConcentration,Homogeneity,StabilityDetermination)BIOANALYTICAL BioanalyticalServices(PK/TK/Immunogenicity/InvitroAssaysforBiologics/Biosimilars&BiopharmaProducts) CustomAssayDevelopmentServices ClinicalTrialSampleAnalysis HostCellProteinAnalysis(HCP) HostCellDNA(HCD)MICROBIOLOGY TimeKillAssays InvitroAntimicrobialTest PathogenDetection TotalMicrobialCount TotalYeastandMouldCount InvitroMICScreening PreservativeEfficacyTests CATEGORIES

Cosmetics DrugsotherthanthosespecifiedinScheduleC/C﴾1﴿﴾ExcludingHomeopathicDrugs﴿ DrugsSpecifiedinScheduleC&C﴾1﴿MOLECULARBIOLOGY

ProteinProduction&Purification Bacterial,Yeast&MammalianSystem QPCR/RTPCR

EnvironmentalFate

Servicesoffered: AlternatetoAnimalStudies EndocrineDisruptorscreening EcotoxicologyStudies Pathogenicity/Infectivity ResidueAnalysis&FieldStudies ReproductiveToxicity GeneticToxicity Acute6pack&RepeatedDoseAnalyticalMethods,Physico­chemicalTesting,5­batchTestingandToxicologicalStudies­EURegistrationsupport PlantProtectionProducts(EURegulation1107/2009) Biocides(BiocidalProductsRegulation528/2012) IndustrialChemicals(REACHRegulation1907/2006)RichExperienceinhandlingActiveIngredientsandFinalProductsTechnicalGrade(Herbicides,Fungicides,Insecticides,Biocidesetc.,)FormulatedProducts(WG/SC/NF/EC/SLetc.,)CombinationInsecticidesBiopesticides

IndependentQualityAssuranceUnit(QAU)ensurescompliancewithin­houseSOPs,GLPandrelatedguidelinesconformingtorespectiveregulatoryspecifications.QAUactivelyreviews/auditsstudyplans,in­lifephases,reportandfacility/process.QAUimpartscontinuousin­houseGLPtrainingtostafftoensurehighestqualityadherenceandcompliancetoOECDGLPprinciples.QUALITYASSURANCEUNIT

Email:bioneeds@bioneeds.in

REACHSERVICES

BioneedsIndiaPrivateLimited,Devarahosahally,SompuraHobli,NelamangalaTq,BangaloreRuralDistrict­562111,Karnataka,INDIATel:+91816­2214400GLPAccreditedPreclinicalDevelopmentCenter BioneedsIndiaPrivateLimited,P­3,PeenyaIndustrialArea,1stMainRoad,Peenya1stStage,Bangalore­560058,Karnataka,INDIATel:+9180­22658400

Chemistry&BiopharmaFacility

+919844457677bioneeds@bioneeds.in www.bioneeds.in