品名
|
品牌
|
貨號
|
規(guī)格
|
單位
|
備注
|
Access人AB血清
|
ACCESS BIOLOGICALS
|
515-HI
|
100ml
|
瓶
|
熱滅活
|
Access人AB血清
|
ACCESS BIOLOGICALS
|
515-HI GI
|
100ml
|
瓶
|
牛凝血酶,熱滅活,伽馬輻照
|
Access人AB血清
|
ACCESS BIOLOGICALS
|
535-HI
|
100ml
|
瓶
|
熱滅活
|
Access人AB血清
|
ACCESS BIOLOGICALS
|
535-HI GI
|
100ml
|
瓶
|
人凝血酶,熱滅活,伽馬輻照
|
人AB血清缺乏針對A和B血型抗原的抗體,這可防止與培養(yǎng)細胞發(fā)生反應,建議用于生物醫(yī)學應用。人AB血清通常用于組織工程、T細胞移植和擴增、細胞治療應用以及PBMC、骨髓、CD9、CD3和CD33的細胞系檢測。此外,人類男性AB血清的主要生長成分是用于CAR-T細胞治療的應用。我們的人類男性AB血清是通過FDA批準的多步驟過程收集的。對每位男性AB捐獻者進行評估,簡要介紹收集過程,并在捐獻人類AB血清之前簽署同意書。我們的材料采用閉環(huán)系統(tǒng)收集和處理,在cGMP下的ISO認證制造設施中,允許材料在世界范圍內用于臨床試驗和商業(yè)用途。
產品優(yōu)勢:
ACCESS人類男性AB血清是一種專利產品,通過cGMP工藝使用人或牛凝血酶制造。
我們在內部收集和制造,使我們能夠提供從血漿捐獻到成品的全閉環(huán)系統(tǒng)的產品。
Access Biologicals直接從美國FDA授權中心收集我們的人類男性AB血漿,使用FDA批準的方法對每個單元進行測試,發(fā)現所有病毒標記物均為陰性
在CLIA和FDA批準的實驗室進行測試
通過核酸試驗檢測HIV-1、HCV和HBV、通過核酸試驗檢測細小病毒B19和HAV、抗HIV 1/2、抗HCV、HBsAg和梅毒
Access提供的附加檢測:寨卡、WNV、恰加斯、抗-HBC、支原體、內毒素、USP無菌、血紅蛋白、滲透壓、pH、化學和物種檢測
可根據要求提供附加測試
0.1μm無菌過濾
提供定制的捐贈池
可根據要求提供熱失活和γ射線輻照
伽馬輻射是經過驗證的過程
病毒驗證研究于2019年3月完成
HUMAN MALE AB SERUM
Human Male AB Plasma-Derived serum can be used for various cell culture applications.
It is a main component needed for culturing human cell lines.
It is often used to replace FBS which is not an ideal supplement for human derived cell lines.
Human Male AB Serum is filtered and cell culture tested for mycoplasma, endotoxin, and sterility.
The Access Advantage:
Our Human Male AB Plasma-Derived Serum is a proprietary product manufactured with either human or bovine thrombin following a cGMP process.
We collect and manufacture internally, allowing us to offer a product using a fully closed-loop system from plasma donation to finished product.
● Access Biologicals directly collects our plasma from FDA licensed centers within the US
● Each unit is tested and found negative for all viral markers using FDA-approved methods
● Testing at CLIA and FDA approved labs
● HIV-1, HCV and HBV by Nucleic Acid Test, Parvo B19 and HAV by Nucleic Acid Test, Anti-HIV 1 / 2, Anti-HCV, HBsAg & Syphilis
● Additional testing provided by Access: Zika, Chagas, WNV, Anti HBC, Mycoplasma, Endotoxin, USP Sterility, Hemoglobin, Osmolality, pH, Chemistry, and Species Testing
● Additional testing available upon request
● 0.1µm sterile-filtered
● Custom donor pools available
● Heat inactivation and gamma irradiation available upon request
● Gamma irradiation is through a validated process
● Virus validation study completed March 2019