Theinvitrocultureofanimalcellscommonlyrequiresamediumrichinnutrients.Thesenutrientsareusuallysuppliedbysupplementingachemicallydefinedmediumwithanimalserum.
Serumoffersahighlybioavailablecomplexofproteinsandaminoacids,lipidsandtriglycerides,vitamins, inorganicmineralsandsalts,aswellas otherminorcomponentsandgrowthfactorsthatpromoteculturesuccess.Serummayalsocontainvaryingconcentrationsofironsequesteringhemeandmitogenicendotoxin.
Whenstoredandusedproperly,animal serumcanbestablymaintainedwithits originalgrowth-promotingcharacteristicsfor severalyears;theimproperstorageor thawingofserumcanquicklydegradethe qualityandstabilityofthisbiologicalfluid, andcanpresentahazardtovaluedcellsin culture.
Collection
GeminiBio-ProductsusesanimalserawhichhavebeencollectedfromthecontinentalUnitedStatesaswellassourcesoutsidetheUSapprovedbytheUnitedStatesDepartmentofAgriculture(USDA).CollectionfacilitiesoutsidetheUnitedStatesareincountriesthathavebeendeclaredfreeofcertainbovinevirusessuchasfootandmouthdiseasebytheUSDA.ThesesourcesareallwithinNorthAmerica.Eachlotofanimalserumiscertifiedastocountryoforigin,assuringwhenapplicable,thatUSDAimportationregulationsarestrictlyfollowed.DocumentationoftraceabilitycanbesupplieduponrequestforeverylotofGeminifetalbovineserum.
Fetalbovineserumiscollectedusingaclosed,asepticcardiocentesismethodinordertominimizehemoglobin,endotoxin,andmicrobialagents.
Processing
SerumprocessingisperformedusingGoodManufacturingPractices(GMP)atrefrigeratedtemperatures.Serumisseparatedfromtheclotbycentrifugation.Sterilefiltrationisperformedusingmultiple,0.1-μmmembranefilters(unlessotherwisespecified).Filteredserumisnormallydispensedintocell-culture-gradePETGbottlesandrapidlyfrozentoatemperatureof-10°Cto-20°C.Serumcanbesuppliedinglassbottlesuponrequest.
GrowthPromotionandCytotoxicity
Ourserumisevaluatedforcellgrowthpromotionand/orcytotoxicity.Celllinesthatarefreeofmycoplasmaandadventitiousviralagentsareculturedtotheequivalentof3–4populationdoublingsinamediumcontaining10%testserum.Cellsareexaminedmicroscopicallyforatypicalmorphologyandevidenceofcytotoxicity.Itisimpracticaltotestseraorotherproductsoneverycelltypeinusebyourcustomers.Ifyouhaveaspecificcelltypeyouwouldliketested,suchasEmbryonicStemcells,wewillgladlydiscussamodifiedtesting programtomeetyourneeds.
FetalBovineSeraandSubstitutes
Becauseofthemanydiversecelltypesinuseandthevariabilityofcell-linematchingprograms,weprovidesamplesforyourownevaluation.Thisistheonlytruemeasureofhowseraorotherproductswillperformforyourspecificapplication.
Sterility
ThesterilityofserumproductsisevaluatedinaccordancewithFederalRegulationsCFR9113.26.Statisticalsamplesaretakenduringtheasepticfillingprocessandtestedforthepresenceofbacteriaandfungi.SamplesareinoculatedintoThioglycolatebrothandSoybeanCaseinDigestbrothandincubatedforupto21daysat21°Cand37°C,respectively.Attheendofthisperiod,culturesareexaminedandmustbedeterminedtobefreeofanymicrobialcontaminationbeforetheproductisreleasedforsale.
VirusScreening
ThescreeningofbovineserumforviralcontaminationisaccomplishedbycultivationofbovinecellsknowntobefreeofbothMycoplasmaandadventitiousbovineviruses.Cellsaregrowntotheequivalentof3to4populationdoublings,usingaminimumserumconcentrationof15%.ThevirusesscreenedareBVD,PI3,andIBR.Noviralscreeningmethodcanbeguaranteedtodetectallvirusesthatmaybepresentinaparticularlotofserum.Whilewestrivetousethemostaccurateandsensitivemethods,eachserumusershouldunderstandthatanyparticularnegativevirustestisnotanabsoluteguaranteeoftheabsenceofthatvirus.
MycoplasmaTesting
MycoplasmatestingisperformedonserumusingtheBarilelarge-volumebrothinoculationmethod.Anyserumlotscontainingdetectablemycoplasmaarerejectedandnotreleasedforsale.
BiochemicalAnalysis
Chemistryvaluesincludingtotalproteincontent,gammaglobulincontent,speciesidentification,hemoglobincontent,osmolality,andpHaredeterminedonallfinishedlotsofserum.EffectiveApril2003,webegantestingallnewlotsoffetalbovineserumforthepresenceoftetracycline;testresultsarereportedontheCertificateofAnalysisthataccompaniestheproduct.
HormoneTesting
EffectiveJune1,2004,allGemCell™USOrigin(Cat#100-500),BenchMark™(Cat#100-106)fetalbovineserum,andFetalplex™(Cat#100-602)animalserumcomplexwillbeassayedforthefollowinghormones:estradiol,insulin,progesterone,testosterone,thyroxine(T4),andtriiodothyronine(T3).ResultswillbereportedontheCertificateofAnalysisthataccompaniestheproduct.
EndotoxinTesting
ThepresenceofendotoxinisdeterminedbytheLimulusAmebocyteLysate(LAL)gelclotmethod.Eachruncontainsacertifiedcontrolperformancestandard.
HeatInactivation
Geminiwillprovideheatinactivationformostserauponrequest,asaservicetoourcustomers.
Thepracticeofheatinactivatingserumwasoriginallydevelopedwhenonlyserumfromadultcowswasavailableforcellculture.Adultserumcontainsimmunefactors,particularlyserumcomplement,whichmayinhibitordestroycellsundercertainconditions.Heatingtheserumto56°Cfor30minutesisintendedtoinactivateserumcomplement.
Fetalbovineserumseldombenefitsfromheatinactivationand,therefore,theprocessisdiscouragedinmostcases.Heatinactivationcandecreasegrowthpromotionability,andaddaconsiderableamountofprecipitatefromproteindenaturation.Wesuggestthecustomerdoasimpletesttocomparenativeserumtoheat-inactivatedserum.
Gemini血清
| 胎牛血清 澳洲血源 | Gemini原装 | 500ml | 货号100-700 |
| 胎牛血清 美国血源 | Gemini原装 | 500ml | 货号100-500 |
| 胎牛血清 南美血源 | Gemini原装 | 500ml | 货号900-108 |
| 胎牛血清 南美血源 | Gemini原装 | 500ml | 货号900-208 |
温馨提示：不可用于临床治疗。
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