Biological Analyses

Confarma

Laboratories

• ConfarmaaSolviasGroupCompany• Foundedin1973• ~100employees• BusinessunitspecializedinBiologicalAnalyses• LaboratorybasedinFrance(Alsace)• 3analyticaldepartments• GMP,cGMP(FDAapproved),GLP,ISO17025,ISO9001

• Microbiology• Chemistry• Toxicology• Virology• Cellbasedassays• Stability• Pesticides• Molecularbiology

Amazing where you can go

CONFARMA FRANCE SAS

Z.I.rueduCanald’AlsaceF-68490Hombourg

Tel.:+33(0)389833720Fax:+33(0)389833729E-Mail:info@confarma.fr

Internet:www.confarma.eu

AnalyticalservicesforallstagesofDevelopment

ComparabilityStudies

AgregationStudies

ProcessImpurities

StructuralCharacterization

Characterization(ICHQ6B)

MethodDevelopment&Validation(ICHQ2)

Stability&ForcedDegradation(ICHQ1A-F/Q5C)

QualityControlAnalysis

PhyschemProperties

Extractables&Leachables

Microbiology

ProductRelatedImpurities

Immunology

StabilityStudies

PotencyTesting

QC&ReleaseTesting

Preclinical PhaseI PhaseII PhaseIII Market

Réalisation:FriedlingGraphique-Rixheim/Kaysersberg-Certifié

SolviasGroup OurAreasofExpertiseforyourProducts

OurExpertise

• SwissCRO• Foundedin1999• ~400employees(>30%withPhD)• EmployeeandManagementowned• LaboratoriesinSwitzerlandandFrance• SubsidiaryintheUS• GMP,cGMP(FDAapproved),GLP,ISO17025,ISO9001

• Smallmolecules• API/excipient• OTC• Herbalmedicines• Antibiotics

• Orthopedic• Spinal• Combinationproducts• Ocular• OTC• Hyaluronicacidgels

• Biopharmaceuticals• Largemolecules/Biosimilars• Cells• Antibodies• Vaccines

• OTC• Ocular• Cream• Hyaluronicacidgels

Pharmaceuticals

MedicalDevices

Biotechnology

Cosmetics

• Sterilitytest (isolators)

• Bioburden• Mycoplasma

SterileProducts

• Genotoxicity assay

• Cytotoxicity• ELISA(kitsand development)

• Wateranalyses• Particulatematter• Residues (pesticides,HCT…)

• QCrelease

In-vitroToxicology

PhysicoChemistry

• Microbiallimit test

• Challengetest

NonSterileProducts

• Chronictoxicity• Biocompatibility (ISO10993)

• Pharmacokineticstudies

• Proteinassays• Enzymaticassays

In-vivoToxicology

Biochemistry

• Identificationof microorganisms: DNAsequencing MicroSEQ®,proteomicprofileMALDI-TOF®

• Wateranalyses• Mapping

Environmental

• Gel-clot• Quantitativetest(allmethods)

• FactorC (chemicaltesting)

•ICHQ1A(R2) •5°C •25°C/60%Cr.H •30°C/65%r.Hand 30°C/75% •40°C/75%r.H •-20°C;-80°C•ASTMf1980

Endotoxins

StabilityStudies

• Disinfectants• CCIT: MIT,DyeTest

• Antibiotics• AMEStest

Studies

• ExperimentalassayforR&D

• InVitroPyrogentest:MAT

• Antibodypotencyassays

CellbasedAssays

Microbiology

Biology

Chemistry

SolviasGroup OurAreasofExpertiseforyourProducts

OurExpertise

• SwissCRO• Foundedin1999• ~400employees(>30%withPhD)• EmployeeandManagementowned• LaboratoriesinSwitzerlandandFrance• SubsidiaryintheUS• GMP,cGMP(FDAapproved),GLP,ISO17025,ISO9001

• Smallmolecules• API/excipient• OTC• Herbalmedicines• Antibiotics

• Orthopedic• Spinal• Combinationproducts• Ocular• OTC• Hyaluronicacidgels

• Biopharmaceuticals• Largemolecules/Biosimilars• Cells• Antibodies• Vaccines

• OTC• Ocular• Cream• Hyaluronicacidgels

Pharmaceuticals

MedicalDevices

Biotechnology

Cosmetics

• Sterilitytest (isolators)

• Bioburden• Mycoplasma

SterileProducts

• Genotoxicity assay

• Cytotoxicity• ELISA(kitsand development)

• Wateranalyses• Particulatematter• Residues (pesticides,HCT…)

• QCrelease

In-vitroToxicology

PhysicoChemistry

• Microbiallimit test

• Challengetest

NonSterileProducts

• Chronictoxicity• Biocompatibility (ISO10993)

• Pharmacokineticstudies

• Proteinassays• Enzymaticassays

In-vivoToxicology

Biochemistry

• Identificationof microorganisms: DNAsequencing MicroSEQ®,proteomicprofileMALDI-TOF®

• Wateranalyses• Mapping

Environmental

• Gel-clot• Quantitativetest(allmethods)

• FactorC (chemicaltesting)

•ICHQ1A(R2) •5°C •25°C/60%Cr.H •30°C/65%r.Hand 30°C/75% •40°C/75%r.H •-20°C;-80°C•ASTMf1980

Endotoxins

StabilityStudies

• Disinfectants• CCIT: MIT,DyeTest

• Antibiotics• AMEStest

Studies

• ExperimentalassayforR&D

• InVitroPyrogentest:MAT

• Antibodypotencyassays

CellbasedAssays

Microbiology

Biology

Chemistry

SolviasGroup OurAreasofExpertiseforyourProducts

OurExpertise

• SwissCRO• Foundedin1999• ~400employees(>30%withPhD)• EmployeeandManagementowned• LaboratoriesinSwitzerlandandFrance• SubsidiaryintheUS• GMP,cGMP(FDAapproved),GLP,ISO17025,ISO9001

• Smallmolecules• API/excipient• OTC• Herbalmedicines• Antibiotics

• Orthopedic• Spinal• Combinationproducts• Ocular• OTC• Hyaluronicacidgels

• Biopharmaceuticals• Largemolecules/Biosimilars• Cells• Antibodies• Vaccines

• OTC• Ocular• Cream• Hyaluronicacidgels

Pharmaceuticals

MedicalDevices

Biotechnology

Cosmetics

• Sterilitytest (isolators)

• Bioburden• Mycoplasma

SterileProducts

• Genotoxicity assay

• Cytotoxicity• ELISA(kitsand development)

• Wateranalyses• Particulatematter• Residues (pesticides,HCT…)

• QCrelease

In-vitroToxicology

PhysicoChemistry

• Microbiallimit test

• Challengetest

NonSterileProducts

• Chronictoxicity• Biocompatibility (ISO10993)

• Pharmacokineticstudies

• Proteinassays• Enzymaticassays

In-vivoToxicology

Biochemistry

• Identificationof microorganisms: DNAsequencing MicroSEQ®,proteomicprofileMALDI-TOF®

• Wateranalyses• Mapping

Environmental

• Gel-clot• Quantitativetest(allmethods)

• FactorC (chemicaltesting)

•ICHQ1A(R2) •5°C •25°C/60%Cr.H •30°C/65%r.Hand 30°C/75% •40°C/75%r.H •-20°C;-80°C•ASTMf1980

Endotoxins

StabilityStudies

• Disinfectants• CCIT: MIT,DyeTest

• Antibiotics• AMEStest

Studies

• ExperimentalassayforR&D

• InVitroPyrogentest:MAT

• Antibodypotencyassays

CellbasedAssays

Microbiology

Biology

Chemistry

Biological Analyses

Confarma

Laboratories

• ConfarmaaSolviasGroupCompany• Foundedin1973• ~100employees• BusinessunitspecializedinBiologicalAnalyses• LaboratorybasedinFrance(Alsace)• 3analyticaldepartments• GMP,cGMP(FDAapproved),GLP,ISO17025,ISO9001

• Microbiology• Chemistry• Toxicology• Virology• Cellbasedassays• Stability• Pesticides• Molecularbiology

Amazing where you can go

CONFARMA FRANCE SAS

Z.I.rueduCanald’AlsaceF-68490Hombourg

Tel.:+33(0)389833720Fax:+33(0)389833729E-Mail:info@confarma.fr

Internet:www.confarma.eu

AnalyticalservicesforallstagesofDevelopment

ComparabilityStudies

AgregationStudies

ProcessImpurities

StructuralCharacterization

Characterization(ICHQ6B)

MethodDevelopment&Validation(ICHQ2)

Stability&ForcedDegradation(ICHQ1A-F/Q5C)

QualityControlAnalysis

PhyschemProperties

Extractables&Leachables

Microbiology

ProductRelatedImpurities

Immunology

StabilityStudies

PotencyTesting

QC&ReleaseTesting

Preclinical PhaseI PhaseII PhaseIII Market

Réalisation:FriedlingGraphique-Rixheim/Kaysersberg-Certifié

Biological Analyses

Confarma

Laboratories

• ConfarmaaSolviasGroupCompany• Foundedin1973• ~100employees• BusinessunitspecializedinBiologicalAnalyses• LaboratorybasedinFrance(Alsace)• 3analyticaldepartments• GMP,cGMP(FDAapproved),GLP,ISO17025,ISO9001

• Microbiology• Chemistry• Toxicology• Virology• Cellbasedassays• Stability• Pesticides• Molecularbiology

Amazing where you can go

CONFARMA FRANCE SAS

Z.I.rueduCanald’AlsaceF-68490Hombourg

Tel.:+33(0)389833720Fax:+33(0)389833729E-Mail:info@confarma.fr

Internet:www.confarma.eu

AnalyticalservicesforallstagesofDevelopment

ComparabilityStudies

AgregationStudies

ProcessImpurities

StructuralCharacterization

Characterization(ICHQ6B)

MethodDevelopment&Validation(ICHQ2)

Stability&ForcedDegradation(ICHQ1A-F/Q5C)

QualityControlAnalysis

PhyschemProperties

Extractables&Leachables

Microbiology

ProductRelatedImpurities

Immunology

StabilityStudies

PotencyTesting

QC&ReleaseTesting

Preclinical PhaseI PhaseII PhaseIII Market

Réalisation:FriedlingGraphique-Rixheim/Kaysersberg-Certifié