ASTM E3042-16美国材料与试验协会标准.pdfVIP

Designation:E3042−16

StandardPracticefor

ProcessSteptoInactivateRodentRetroviruswithTriton

X-100Treatment1,2

ThisstandardisissuedunderthefixeddesignationE3042;thenumberimmediatelyfollowingthedesignationindicatestheyearof

originaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.A

superscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.

1.Scope2.1.1clarified,cellfreeintermediate,n—in-processpool

1.1Thispracticeassureseffectiveinactivationof≥4log10oflocateddownstreamofthecellclarificationunitoperation(s),

infectiousrodentretrovirus(thatis,reductionfrom10000to1whichshouldincludeafiltrationstepof≤0.2µmnominalpore

infectiousrodentretrovirusorremovalof99.99%ofinfectioussize,andupstreamoftheinitialpurificationstepinthe

rodentretroviruses)inthemanufacturingprocessesofmono-purificationprocessofamonoclonalantibodyorIgGFcfusion

clonalantibodiesorimmunoglobulinG(IgG)Fcfusionpro-protein.

teinsmanufacturedinrodent-derivedcelllinesthatdonotDiscussion—Cellclarificationunitoperationsare

targetretroviralantigens.Rodentretrovirusisusedasamodelperformedonthecellculturesupernatant.Cellclarification

forrodentcellsubstrateendogenousretrovirus-likeparticlesunitoperationscanbeoneormoreofthefollowingopera-

potentiallypresentintheproductionstreamoftheseproteins.