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IntegrityBio
Integrity Bio, Inc. was originally founded as Integrity Biosolution in 2003. Offering Formulation Development services since its inception the company quickly endeavored into the large project of designing and constructing GMP compliant parenteral manufacturing facilities in an adjacent building to the research laboratory. After commissioning and validation were completed the first of many successful cGMP manufacturing campaigns were launched in 2007.
Since that time many additional services and improvements have been made to support that operation. The addition of cGMP Stability Programs to service our existing clients was a great success and prompted the expansion of our GMP Quality Control Laboratory. We have developed, transferred, qualified, and validated many assays from TOC to HPLC and beyond. Most recently the addition of Ultra-Filtration / Dia-Filtration (UFDF) via Tangential Flow Filtration (TFF) has been added to our list of capabilities. This provided the ability to "Turn Key" most clients' projects from Formulation Development through Clinical Trials.
All these changes and improvements prompted the new name and logo. So in November of 2009 we became Integrity Bio, Inc.
Company Contact:
Michael Reilly
Phone:
(805) 445-8422 ext.110
Fax:
(805) 445-8428
Email:
michael.reilly@integritybio.com
Website:
http://www.integritybio.com/
Address:
820 Calle PlanoCamarillo, CA 93012 USA
Michael ReillyPhone:
(805) 445-8422 ext.110Fax:
(805) 445-8428Email:
michael.reilly@integritybio.comWebsite:
http://www.integritybio.com/Address:
820 Calle PlanoCamarillo, CA 93012 USA- USA
ANALYTICAL
Service Type
DeviceInjection DeviceDifferential Scanning CalorimetryMethodsMethod DevelopmentMethod TransferMethod ValidationOphthalmic Formulation/PackagingProcess Analytical TechnologyTests - Impurities/DegradationForced DegradationImp./Deg QuantitationTests - PhysicalParticle SizeParticulate MatterPhysical TestingTests - Protein/Peptide/DNA/OligoElectrophoresisElisa/Western BlotPeptide mappingProtein Aggregation/DeaggregationProtein Biophysical CharacterizationProtein Carbohydrate AnalysisProtein Chemical StabilityProtein Dosage FormProtein Primary StructureProtein Secondary/Tertiary StructureTests - StabilityAccelerated StabilityICH/Commercial Stability StorageICH/Commercial Stability TestingPhotostabilityStability Storage (I/II)Stability Testing (I/II)Tests/Analysis - OtherAssay/PotencyComparator AnalysisCompendial TestingContent UniformityInvestigative AnalysisLCMS AnalysisMoisturePolymer analysisResidual Solvent AnalysisSample AnalysisThermal Analyses/DSCTets - ReleaseLot and Batch Release TestingWet Chemistry
BIO-ANALYTICAL
CONSULTANT
Formulation Categories-Consultant
BiopharmaceuticalsBiosimilarsCombination ProductsGenericsInjectableDual Chamber CartridgesDual Chamber Prefilled SyringesInject. DepotInjectable LyophilizedInjectable SolutionInjection Pens/AutoinjectorsPrefilled SyringeLiposomesMedical DeviceParticle EngineeringProdrugs/PEGTransdermal/TopicalWound care productsVeterinary
DRUG DELIVERY DEVICES
Injection Devices
FACILITY REGULATORY STATUS
Facility subcategories
FORMULATION/MANUFACTURING
API/Business Sector Types
Development Stage
MICROBIOLOGICAL TESTING
Development Phase Micro
Formulations Serviced
Microbiology Services
Bacterial Endotoxin TestingBioburden TestingBiological Indicator AnalysisCleanroom ValidationsCompendial TestingContainer Closure TestingEnvironmental AssessmentsEnvironmental AssessmentsEnvironmental MonitoringFilter ValidationFungicidal ActivityGrowth Promotion TestingMedia FillsMicrobial IdentificationMicrobial Limit TestingParticulate Matter USPPreservative Effectiveness TestingProduct release servicesPyrogen testingSterility TestingSterilization ValidationsWater ActivityWater Testing (USP)
PACKAGING/FILLING/LABELING
Development Stage
PREFORMULATION
Preformulation Services
Accelerated StabilityCrystallization Process DevelopmentExcipient CompatibilityForced Degradation StudiesFTIRHydrates and SolvatesHygroscopicityMelting PointMoisture ContentOsmolarityParticle size measurements pH-Rate profilesPhysical PropertiesProtein PreformulationSolubilitySpecific GravityThermal Analyses/DSC

