通过沉降速度聚合定量抗体疗法的最佳实践_2022.pdfVIP

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BestPracticesforAggregateQuantitationofAntibodyTherapeuticsbySedimentationVelocity

AnalyticalUltracentrifugation

1,†2,†3456

GeorgeM.Bou-Assaf,IvanL.Budyak,MichaelBrenowitz,EricS.Day,DavidHayes,JohnHill,

2784,

RanajoyMajumdar,PaolaRinghieri,PeterSchuck,JasperC.Lin*

1AnalyticalDevelopment,Biogen,225BinneySt.,CambridgeMA02142

2BioproductResearchandDevelopment,LillyResearchLaboratories,EliLillyandCompany,Indianapolis,IN

46285,USA

3DepartmentsofBiochemistryandMolecularPharmacology,AlbertEinsteinCollegeofMedicine,1300

MorrisParkAvenue,Bronx,NY10461

4PharmaceuticalDevelopment,GenentechaMemberoftheRocheGroup,1DNAWay,SouthSan

Francisco,CA94080

5IntlSoSci,23WashingtonSt.Gorham,NH03581

6DepartmentofBioengineering,UniversityofWashington,Seattle,WA98105

7AnalyticalDevelopmentBiotechDepartment,MerckSeronoS.p.a,Guidonia,RM,Italy;anaffiliateofMerck

KGaA

8LaboratoryofDynamicsofMacromolecularAssembly,NationalInstituteofBiomedicalImagingand

Bioengineering,NationalInstitutesofHealth,13SouthDrive,Bethesda,MD20892,(schuckp@)

†Theseauthorscontributedequallytothiswork.

*Towhomcorrespondenceshouldbeaddressed:lin.jasper@,GenentechaMemberoftheRoche

Group,1DNAWay,SouthSanFrancisco,CA94080

Theauthorsdeclarethefollowingfinancialinterests/personalrelationshipswhichmaybeconsideredas

potentialcompetinginterests:

GMBisanemployeeofBiogenInc.

ILBandRMareemployeesofEliLillyandCompany

ESDandJCLareemployeesofGenentechInc.

PRisanemployeeof