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Cygnus F030 BSA 残留检测试剂盒 BSA ELISA Kit (F030)

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Cygnus F030 BSA 残留检测试剂盒 BSA ELISA Kit (F030)

Cygnus试剂盒Cygnus technologies热销产品

Cygnus热销产品：cygnus f975、cygnus f410检测试剂盒、cygnus f550

F015 CHO宿主蛋白残留检测试剂盒
F030 BSA残留检测试剂盒
F400 Protein A 试剂盒
F410 大肠杆菌宿主蛋白残留检测试剂盒
CM015 CHO宿主蛋白残留检测试剂盒

F140 酵母菌宿主蛋白残留检测试剂盒
F150 HEK293宿主蛋白残留检测试剂盒
F050 蛋白A检测试剂盒
F500 Vero cell HCP ELISA试剂盒

品牌商名称：cygnus
公司官网：

Cygnus F030 BSA 残留检测试剂盒 BSA ELISA Kit (F030)

Product Information
Product Type: ELISA Kit
Storage: All kit reagents 2°C to 8°C
Assay format: 96 Well Plate
Time to result: ~1 hr. 50 min
LOD: ~125 pg/mL
LLOQ: ~250 pg/mL
Recommended Diluent: F031A

Description

This kit is intended for quantitating bovine serum albumin (BSA). The use of serum-free defined media greatly reduces the number of potential impurities, but it may still be necessary to determine the levels of trace impurities, such as proteins and growth factors used in these media. Most commercial formulations of serum-free media contain significant amounts of albumin and transferrin, either of bovine or human origin, and insulin from various species.

This highly sensitive assay for BSA has a detection limit of <250 pg/ml. It can be used to optimize purification processes and in routine quality control of in-process streams, as well as in testing the final product. Please use Sample Diluent, Item No. F031A, with these kits; available separately.

描述
该试剂盒用于定量牛血清白蛋白 (BSA)。 使用无血清成分的培养基大大减少了潜在杂质的数量，但仍可能需要确定微量杂质的水平，例如这些培养基中使用的蛋白质和生长因子。 大多数商业化的无血清培养基配方含有大量的白蛋白和转铁蛋白，无论是来自牛的还是来自人的，以及来自不同物种的胰岛素。

这种高灵敏度的 BSA 检测方法的检测限 <250 pg/ml。 它可用于优化纯化过程和过程中流的常规质量控制，以及测试最终产品。 请在这些套件中使用样品稀释剂，货号 F031A； 可单独购买。

Kit Components
Anti-BSA:HRP Conjugate
BSA Standards Set, A-E
TBS Wash Concentrate, 20X
Stop Solution
TMB Substrate for ELISA
Anti-BSA Coated Microtiter Strips

Cygnus其他相关试剂盒：

Cygnus   I028 Sample Diluent Buffer
Cygnus   F220 NS/0 HCP ELISA 试剂盒
Cygnus   F050h Protein A-h ELISA 试剂盒
Cygnus   F015     CHO HCP ELISA Kit 试剂盒              1 Kit
Cygnus   F550     CHO HCP ELISA Kit, 3G 试剂盒           1 Kit
Cygnus   CM015    CHO-CM HCP ELISA Kit 试剂盒                 1 Kit
Cygnus   F410     E.coli HCP ELISA Kit 试剂盒                1 Kit
Cygnus   F500     Vero Cell HCP ELISA Kit 试剂盒       1 Kit
Cygnus   F510     BHK HCP ELISA Kit 试剂盒              1 Kit
Cygnus   F135     S.cerevisiae HCP ELISA Kit              1 Kit
Cygnus   F020     SF9 HCP ELISA Kit 试剂盒                1 Kit
Cygnus   F650     HEK 293 HCP ELISA Kit 试剂盒               1 Kit
Cygnus   F490     L.lactis HCP ELISA Kit 试剂盒           1 Kit
Cygnus   F300     MRC5 HCP ELISA Kit 试剂盒                     1 Kit
Cygnus   F650     HEK 293 HCP ELISA Kit 试剂盒         1 Kit
Cygnus   F230     A549 HCP ELISA Kit 试剂盒            1 Kit
Cygnus   F220     NS/0 HCP ELISA Kit 试剂盒                1 Kit
Cygnus   F450     P.fluorescens HCP ELISA Kit               1 Kit
Cygnus   F530     PER.C6 HCP ELISA Kit 试剂盒             1 Kit
Cygnus   F140     Pichia pastoris HCP ELISA Kit          1 Kit
Cygnus   F240     Total Goat Milk Proteins ELISA Kit      1 Kit
Cygnus   F320     S.aureus HCP ELISA Kit                  1 Kit
Cygnus   F180     SP2/0 HCP ELISA Kit 试剂盒                1 Kit
Cygnus   F500     Vero Cell HCP ELISA Kit 试剂盒          1 Kit
Cygnus   F120     Bovine Transferrin ELISA Kit 试剂盒        1 Kit
Cygnus   F030     BSA ELISA Kit 试剂盒                       1 Kit
Cygnus   F280     Insulin ELISA Kit, Ultra-Sensitive          1 Kit
Cygnus   F045     Mouse IgG1 ELISA Kit 试剂盒                1 Kit
Cygnus   F210     Goat IgG ELISA Kit 试剂盒                  1 Kit
Cygnus   F165     Human IgA ELISA Kit 试剂盒                 1 Kit
Cygnus   F070     Bovine IgG ELISA Kit 试剂盒                1 Kit
Cygnus   F290     Bovine Plasma Proteins ELISA Kit 试剂盒    1 Kit
Cygnus   F160     Human IgG, Total, ELISA Kit 试剂盒         1 Kit
Cygnus   F170     Human IgM ELISA Kit 试剂盒                 1 Kit
Cygnus   F055     Human Serum Albumin ELISA Kit 试剂盒        1 Kit
Cygnus   F035N    Human Transferrin ELISA Kit 试剂盒          1 Kit
Cygnus   F050     Protein A ELISA Kit 试剂盒                 1 Kit
Cygnus   F050H     Protein A-h ELISA Kit (human IgG)          1 Kit
Cygnus   F040     Insulin ELISA Kit 试剂盒                   1 Kit
Cygnus   F046     Mouse IgG2a ELISA Kit 试剂盒               1 Kit
Cygnus   F047     Mouse IgG2b ELISA Kit 试剂盒               1 Kit
Cygnus   F090     Mouse IgM ELISA Kit 试剂盒                 1 Kit
Cygnus   F049     Mouse Total IgG ELISA Kit 试剂盒           1 Kit
Cygnus   F400     Protein A ELISA Kit 试剂盒                 1 Kit

Cygnus Technologies CM015 CHO-CM HCP ELISA 试剂盒

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Cygnus Technologies CM015 CHO-CM HCP ELISA 试剂盒

Cygnus试剂盒Cygnus technologies热销产品

Cygnus热销产品：cygnus f975、cygnus f410检测试剂盒、cygnus f550

品牌商名称：cygnus
公司官网：

Cygnus technologies, Inc. （天鹅公司） 是美国一家专门从事生物工程和制药过程中残留物检测的一系列产品。生物制品生产过程中存在许多影响产品质量的残留物，诸如特殊重组表达系统中宿主细胞蛋白（ Host Cell rotein, HCP ）的残留以及生物制品加工过程中培养物残留的污染物。塞纳斯公司提供了广泛而灵敏度极高的一系列用于检测生物工程残留物的产品，在寻求最佳纯化效果和日常质量控制过程中使用塞纳斯的产品可以方便地得到理想的实验结果。

产品主要包括以下几类：
ELISA 试剂盒－ 检测宿主细胞蛋白残留和生物制品生产过程污染物。

Western Blot 试剂盒－ 检测并鉴定常用重组表达系统中的宿主细胞蛋白。

免疫学检测试剂－ 为生物医药行业提供检测生物制品免疫原性的方法。

抗体－ HCP 抗体和检测微生物用抗体。

缓冲液－ 样品稀释缓冲液和酶标抗体稀释缓冲液

F015 CHO 宿主蛋白残留检测试剂盒

F030 BSA 残留检测试剂盒

F410 大肠杆菌宿主蛋白残留检测试剂盒

CM015 CHO 宿主蛋白残留检测试剂盒

F140 酵母菌宿主蛋白残留检测试剂盒

F150 HEK293 宿主蛋白残留检测试剂盒

F050 蛋白 A 检测试剂盒
Cygnus Technologies, Inc. provides the Biotechnology and Biopharmaceutical industry with products and analytical methods, designed to accelerate the R&D phase, improve process development and reduce the costs associated with labor intensive quality control procedures. We offer a comprehensive menu of well validated convenient to use microtiter plate ELISA methods to detect Host Cell Proteins from specific recombinant expression systems and bioprocess contaminants used in culture media as well as transgenic expression systems in goats and cattle. These simple to use kits are highly sensitive and are intended to aid in optimal purifications process development and routine quality control.

CHO-CM HCP ELISA Kit (CM015)

Product Information
Product Type: ELISA Kit
Storage: All kit reagents 2°C to 8°C
Target Expression System: CHO
Species Group: Mammalian
Species: Chinese hamster
Assay format: 96 Well Plate
Time to result: ~3 hrs. 50 min
LOD: 100 pg/mL
LLOQ: ~0.7 ng/mL
Recommended Diluent: I028

Description

This assay is intended for use with pharmaceutical products secreted into protein-free CHO growth media. The antibody is raised and affinity-purified against, then calibrated with HCPs typically found in CHO protein-free conditioned media. Special procedures were utilized in the generation of these antibodies to ensure that low molecular weight and less immunogenic impurities, as well as high molecular weight components, would be represented. Our assay qualification has determined that the LOD for this kit is <200 pg/ml. Please use Sample Diluent, Item No. I028, with these kits; available separately.

描述
该测定旨在用于分泌到无蛋白质 CHO 生长培养基中的药物产品。 产生抗体并对其进行亲和纯化，然后用通常在无 CHO 蛋白条件培养基中发现的 HCP 进行校准。 在产生这些抗体时使用了特殊程序，以确保代表低分子量和较少免疫原性杂质以及高分子量成分。 我们的检测鉴定已确定该试剂盒的 LOD <200 pg/ml。 请在这些套件中使用样品稀释剂，货号 I028； 可单独购买。

Kit Components
Anti-CHO-CM:HRP Conjugate
CHO-CM HCP Standards Set, A-G
Stop Solution
TBS Wash Concentrate, 20X
TMB Substrate for ELISA
Anti-CHO Coated Microtiter Strips

Cygnus Vero Cell HCP ELISA Kit (F500)试剂盒

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Cygnus Vero Cell HCP ELISA Kit (F500)试剂盒

Cygnus试剂盒Cygnus technologies热销产品

Cygnus热销产品：cygnus f975、cygnus f410检测试剂盒、cygnus f550

品牌商名称：cygnus
公司官网：

Cygnus Technologies, Inc.美国赛纳斯科技公司简介

This product has been depleted and replaced with Vero Cell 2G HCP ELISA Kit (F975).

We have resupplied F500 due to its capture and detection antibody stock depletion.

Cygnus Technologies, Inc.(美国赛纳斯科技公司)是一家专为疫苗生产企业、基因工程药企、研发部门及QA部门(品质保证部门)提供宿主细胞蛋白残留检测和生物工艺污染物检测技术和产品的世界*的美国公司。包括美国和中国在内的全球生物制药企业,生物制品生产过程中存在许多影响产品质量的残留物,诸如特殊重组表达系统中宿主细胞蛋白(Host Cell Protein,HCP)的残留以及生物制品加工过程中培养物残留的污染物(Bioprocess Contaminant, BC)。美国Cygnus公司提供了种类广泛而灵敏度极高的一系列用于检测生物工程残留物的HCP ELISA试剂盒和BC ELISA试剂盒等产品,在寻求*纯化效果和日常质量控制过程中使用美国Cygnus公司的产品可以很方便地得到理想的实验结果。

美国Cygnus公司提供的ELISA试剂盒产品主要包括以下两类:

Host Cell Protein Analysis ELISA Kits(宿主细胞蛋白分析ELISA试剂盒)

其来源种属有:哺乳动物细胞、细菌、酵母、昆虫细胞、转基因细胞。

Cygnus Vero Cell HCP ELISA Kit (F500)

Product Information
Product Type: ELISA Kit
Storage: All kit reagents 2°C to 8°C
Target Expression System: Vero Cell
Species Group: Mammalian
Species: African green monkey

Description

Important Change Notification Memo: Vero Cell HCP ELISA Kit

New Vero Cell 2G HCP ELISA Kit, Item Number F975 now available

Expression of viral vaccines and other therapeutic proteins in Vero cells is a cost-effective method for the production of commercial quantities of a drug substance. This kit was developed using the final product and in-process samples for four different products from four vaccine manufacturers. These products included whole virus vaccines as well as recombinant proteins. The broadly reactive, affinity-purified, polyclonal antibodies demonstrate a high degree of conserved HCP across all Vero cell lines tested. The robustness of this sensitive and specific ELISA method facilitates successful validation for almost any product expressed in Vero cells. This kit has an LOD of ~0.7 ng/ml.

描述
重要变更通知备忘录：Vero Cell HCP ELISA 试剂盒

新的 Vero Cell 2G HCP ELISA 试剂盒，货号 F975 现已上市

在 Vero 细胞中表达病毒疫苗和其他治疗性蛋白质是生产商业数量的药物物质的一种经济有效的方法。 该试剂盒是使用来自四家疫苗制造商的四种不同产品的最终产品和过程中样品开发的。 这些产品包括全病毒疫苗和重组蛋白。 广泛反应、亲和纯化的多克隆抗体在所有测试的 Vero 细胞系中都表现出高度保守的 HCP。 这种灵敏且特异的 ELISA 方法的稳健性有助于成功验证几乎所有在 Vero 细胞中表达的产品。 该试剂盒的 LOD 约为 0.7 ng/ml。

Kit Components
Anti-Vero Cell:HRP Conjugate
Vero Cell HCP Standards Set, A-F
Stop Solution
TBS Wash Concentrate, 20X
TMB Substrate for ELISA
Anti-Vero Cell Coated Microtiter Strips

Cygnus F410 大肠杆菌蛋白残留检测试剂盒 E. coli HCP ELISA Kit (F410)

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Cygnus F410 大肠杆菌蛋白残留检测试剂盒 E. coli HCP ELISA Kit (F410)

品牌商名称：cygnus

Cygnus Technologies, Inc.美国赛纳斯科技公司简介

Cygnus Technologies, Inc.(美国赛纳斯科技公司)是一家专为疫苗生产企业、基因工程药企、研发部门及QA部门(品质保证部门)提供宿主细胞蛋白残留检测和生物工艺污染物检测技术和产品的世界*的美国公司。包括美国和中国在内的全球生物制药企业,生物制品生产过程中存在许多影响产品质量的残留物,诸如特殊重组表达系统中宿主细胞蛋白(Host Cell Protein,HCP)的残留以及生物制品加工过程中培养物残留的污染物(Bioprocess Contaminant, BC)。美国Cygnus公司提供了种类广泛而灵敏度极高的一系列用于检测生物工程残留物的HCP ELISA试剂盒和BC ELISA试剂盒等产品,在寻求*纯化效果和日常质量控制过程中使用美国Cygnus公司的产品可以很方便地得到理想的实验结果。

美国Cygnus公司提供的ELISA试剂盒产品主要包括以下两类:

Host Cell Protein Analysis ELISA Kits(宿主细胞蛋白分析ELISA试剂盒)

其来源种属有:哺乳动物细胞、细菌、酵母、昆虫细胞、转基因细胞。

Product Information
Product Type: ELISA Kit
Storage: All kit reagents 2°C to 8°C
Target Expression System: E. coli
Species Group: Bacterial
Species: E. coli
Assay format: 96 Well Plate
Time to result: ~2 hrs. 20 min
LOD: 0.2 ng/mL
LLOQ: ~1 ng/mL
Recommended Diluent: I028

英文名称: E.coli HCP ELISA Kit
产品应用: 大肠杆菌HCP检测
中文名称: 大肠杆菌HCP检测试剂盒
品牌: Cygnus
货号: F410
规格型号: 96T/盒
保存温度: 2~8℃
产品种类: ELISA试剂盒

Description

This kit was developed using broadly reactive polyclonal antibodies to the hundreds of different host cell proteins (HCPs) and is intended for use in determining the presence of E. coli HCP impurities in products manufactured by recombinant expression. Our assay validation has determined the LOD for this kit is ~0.2 ng/ml. Please use Sample Diluent, Item No. I028, with these kits; available separately.

描述
该试剂盒是使用针对数百种不同宿主细胞蛋白 (HCP) 的广泛反应性多克隆抗体开发的，旨在用于确定通过重组表达生产的产品中是否存在大肠杆菌 HCP 杂质。 我们的检测验证已确定该试剂盒的 LOD 为 ~0.2 ng/ml。 请在这些套件中使用样品稀释剂，货号 I028； 可单独购买。

Kit Components
Anti-E. coli:HRP Conjugate
E. coli HCP Standards Set, A-F
TBS Wash Concentrate, 20X
Stop Solution
TMB Substrate for ELISA
Anti-E. coli Coated Microtiter Strips

产品英文名称:Cygnus F410 E.coli HCP ELISA Kit

产品中文名称:Cygnus F410 大肠杆菌宿主细胞ELISA检测试剂盒

Cygnus F410 E.coli HCP 大肠杆菌宿主细胞ELISA检测试剂盒 产品介绍:Cygnus F410 E.coli HCP 大肠杆菌宿主细胞ELISA检测试剂盒主要设计用于检测产物重组表达过程中大肠杆菌宿主细胞污染,试剂盒使用的多克隆抗体对数百种HCPs具有反应性。Cygnus F410 E.coli HCP 大肠杆菌宿主细胞ELISA检测试剂盒检测*浓度可达到 0.2ng/mL。ELISA检测相比Western Blot:Western Blots检测过程复杂并需借助程序分析结果。而且,Western Blot本质上是定性分析,不能得到定量结果,检测灵敏性也受到样本体积的限制。Western Blot在下游纯化过程中检测产物HCPs缺乏灵敏度和特异性。而微量滴定板ELISA检测可以克服上述限制。ELISA具备高度灵敏性,可获得半定量结果,是纯化工艺,过程控制,常规质量检测的*选择。

产品使用时一定要做好保护措施:

0.5M硫磺酸有强腐蚀性,要避免接触眼睛、皮肤和衣物。检测前所有试剂都要平衡到室温。

  • Cygnus F410 E.coli HCP ELISA Kit 检测原理:

大肠杆菌E. coli检测是一个双位点酶联免疫检测。样本中包含的E. coli HCPs蛋白与标记有抗-E. coli 抗体的辣根过氧化物酶同时反应,反应发生在之前涂有一层吸附性抗-E. coli 蛋白抗体的微量滴定板中进行。免疫反应构成为夹层式结构:固相抗休-HCP-酶标记抗体。反应结束后清洗微量滴定板去除未结合反应物。添加TMB作用底物反应。微量滴定板读数器上测定水解物浓度,水解物浓度与E. coli  HCPs蛋白浓度成比例。用提供的标准液绘制标准曲线,根据读数可以计算出E. coli HCPs蛋白含量。

  • Cygnus F410 大肠杆菌宿主细胞ELISA检测试剂盒检测过程:

取出所有试剂平衡到室温→分别移取25μl Cygnus F410 大肠杆菌宿主细胞ELISA检测试剂盒标准液,对照物和样品至待测孔→移取100μl anti-E. coli:HRP(#F411)至每孔→密封滴定板,摇床室温温育90分钟,180rpm→清空小孔,用纸吸干残留液,350μl清洗缓冲液清洗4次→加100μl TMB 作用物(#F005)→室温静置30分钟,不需摇床→加100μl反应终止液(#F006)→分光光度计450/650nm读数

  • Cygnus F410 E.coli HCP ELISA Kit 检测结果分析:

Cygnus F410 E.coli HCP ELISA Kit 标准液(0, 1, 3, 12, 40, 100ng/mL)可用于制作标准曲线,标准液浓度相当于免疫反应HCP总浓度。根据测定的小孔中标准液吸光值绘制标准曲线。Cygnus F410 E.coli HCP ELISA Kit 检测结果数据分析可以使用计算机选配曲线,例如点到点,三次样本函数,或四参数逻辑曲线。不要使用线性回归分析修改样品吸光值,这样会出现显著误差。也可以手工绘图,Y轴标注吸光值,X轴标注浓度。然后根据样品吸光值计算出样品中HCP浓度。(操作时每一浓度标准液都要滴定到两个小孔中,以便计算平均分光光度值,样品也需计算平均吸光值)。

Cygnus F410 E.coli HCP ELISA Kit 组成成份:

  • Anti- E. coli:HRP(辣根过氧化物酶标记)            1x12mL    F411(Product#)
  • Anti- E. coli coated微量滴定板                        12×8孔   F412
  • E. coli HCP标准液(0, 1, 3, 12, 40, 100ng/mL)     1mL/瓶  F413
  • Stop Solution终止液(0.5M硫磺酸)             1x12mL F006
  • TMB (3,3’,5,5’-四甲基联苯氨)                          1x12mL  F005
  • Wash Concentrate清洗物(20倍浓缩)                1x50mL    F004

Cygnus相关试剂盒
A549 HCP, Ab, goat IgG fraction A549-PA ￥2,590.00 cygnus
A549 HCP, Ab,goat  affinity purified A549-AF ￥9,800.00 cygnus
 A549 HCP ELISA Kit  F230 ￥8,750.00 cygnus
A549 HCP Western Blot Kit F235 ￥6,300.00 cygnus
Alkaline Phosphatase Diluent/Stabilizer  I-045 ￥1,750.00 cygnus
 I-040 ￥2,800.00 cygnus
 Alk. Phos. Diluent/Stabilizer with HAMA blocker  I-045H ￥2,800.00 cygnus
 I-040H ￥4,200.00 cygnus
Anti-human IgG4:HRP IM154 ￥2,800.00 cygnus
 Bovine Plasma Proteins, Ab,   rabbit affinity purified  BPP04-AF ￥9,800.00 cygnus
 Bovine Serum Albumin ELISA （BSA残留检测试剂盒）  F030 ￥6,930.00 cygnus
 Bovine Transferrin Antigen Concentrate  F121G ￥2,100.00 cygnus
 Bovine Transferrin ELISA （牛转铁蛋白ELISA kit（宿主残留蛋白检测试剂盒）  F120 ￥6,930.00 cygnus
CHO CM HCP Antigen Concentrate  F063CM ￥4,200.00 cygnus
 CHO-CM HCP ELISA Kit （CHO宿主蛋白残留检测试剂盒）  CM015 ￥8,750.00 cygnus
CHO-CM HCP Western Blot kit CM060 ￥6,300.00 cygnus
 CHO HCP ELISA Kit （CHO宿主蛋白残留检测试剂盒）  F015 ￥8,750.00 cygnus
CHO HCP Western Blot kit (Lysate) F060 ￥6,300.00 cygnus
CHO Lysate HCP Antigen Concentrate F018H-10 ￥3,500.00 cygnus
E.coli HCPs, Ab, goat neat serum F117 ￥2,030.00 cygnus
E.coli HCPs, Ab, goat IgG fraction F117-PA ￥2,590.00 cygnus
E.coli HCPs, Ab, goat affinity purified AP117 ￥9,800.00 cygnus
 E. coli HCP Antigen Concentrate F413H ￥3,500.00 cygnus
 E-coli-HRP HCP ELISA kit F410 ￥8,750.00 cygnus
 E-coli-HRP HCP WB F415 ￥6,300.00 cygnus
 FG Blocker, 1L IM107 ￥1,400.00 cygnus
 Goat, anti-human IgA, 1mL IM140 ￥2,450.00 cygnus
 Goat, anti-human IgA, IgG, IgM, heavy & light chains IM102 ￥2,450.00 cygnus
 Goat, anti-human IgD, 1mL IM141 ￥2,450.00 cygnus
Goat, anti-human IgE, 1mL IM142 ￥2,450.00 cygnus
Goat, anti-human IgG, Fc gamma chain, 1mL IM143 ￥2,450.00 cygnus
 Goat, anti-human IgM, 1mL IM144 ￥2,450.00 cygnus
Goat IgG ELISA  F210 ￥6,930.00 cygnus
Goat Milk Proteins ELISA kit F240 ￥8,750.00 cygnus
Goat Milk Proteins Western Blot kit  F245 ￥6,300.00 cygnus
Pseudomonas fluorescens, Ab, goat IgG fraction  7-04PA ￥2,590.00 cygnus
 Pseudomonas fluorescens, Ab, goat neat serum  7-04 ￥2,030.00 cygnus
 Pseudomonas, guinea pig neat serum  8-57 ￥2,030.00 cygnus
Saccharomyces cerevisiae HCPs, Ab, goat neat serum 82-SC ￥2,030.00 cygnus
Saccharomyces cerevisiae HCPs, Ab, goat IgG fraction 82SC-PA ￥2,590.00 cygnus
Saccharomyces cerevisiae HCPs, Ab, goat affinity purified 82SC-AF ￥19,600.00 cygnus
Saccharomyces  cerevisiae HCP  Antigen Concentrate  F138H ￥2,800.00 cygnus
Saccharomyces  cerevisiae HCP  ELISA    F135 ￥8,750.00 cygnus
Saccharomyces cerevisiae HCP Western Blot kit F130 ￥6,300.00 cygnus
SF9 HCP ELISA  F020 ￥8,750.00 cygnus
SF9 HCP Western Blot kit F125  ￥6,300.00 cygnus
SF9 Insect Cell HCPs, Ab, rabbit neat serum 12-SF9 ￥2,030.00 cygnus
SF9 Insect Cell HCPs, Ab, rabbit IgG fraction 12-SF9-PA ￥2,590.00 cygnus
Shigella, Ab, rabbit neat serum 40059 ￥2,030.00 cygnus
Shigella, Ab, rabbit IgG fraction 9-03-PA ￥2,590.00 cygnus
SP 2/0 HCPs, Ab, goat neat serum SP110 ￥2,030.00 cygnus
SP 2/0 HCPs, Ab, goat IgG fraction SP110-PA ￥2,590.00 cygnus
SP 2/0 HCPs, Ab, goat affinity purified SP110-AF ￥9,800.00 cygnus
 SP 2/0 HCP Antigen Concentrate  F186C ￥4,200.00 cygnus
 SP 2/0 HCP ELISA Kit  F180 ￥8,750.00 cygnus
SP 2/0 HCP Western Blot kit F185 ￥6,300.00 cygnus
Streptococcus pneumoniae, Ab, rabbit neat serum 8-31B ￥2,030.00 cygnus
Streptococcus pneumoniae, Ab, guinea pig IgG fraction 8-42A ￥2,030.00 cygnus
TMB & Stop Solution, substrate kit, 50 mL  IM109 ￥1,400.00 cygnus
TMB Liquid Substrate for use in ELISA  F027 ￥1,050.00 cygnus
TMB Liquid Substrate for use in ELISA  F100027 ￥4,200.00 cygnus
TMB Liquid Substrate for use in Western Blots  F129 ￥1,050.00 cygnus
TMB Liquid Substrate for use in Western     Blots  F100029 ￥4,200.00 cygnus
Total Goat Milk Proteins, Ab, rabbit neat serum  4042 ￥2,030.00 cygnus
Total Goat Milk Proteins, Ab, rabbit IgG fraction 4042-PA ￥2,590.00 cygnus
Total Goat Milk Proteins, Ab, rabbit affinity purified 4042-AF ￥9,800.00 cygnus
Vero cell HCP, Ab goat neat serum VC807 ￥2,030.00 cygnus
Vero cell HCP, Ab, goat affinity purified VC807.5-AF ￥5,600.00 cygnus
Vero cell HCP, Ab, goat affinity purified VC807-AF ￥9,800.00 cygnus
Vero cell Antigen Concentrate (for ELISA) F503H ￥4,200.00 cygnus
Vero cell Control Antigen (for Western Blot) F507 ￥1,050.00 cygnus
Vero cell HCP ELISA kit F500 ￥8,750.00 cygnus

Cygnus CHO HCP ELISA Kit, 3G (F550)中文说明书

发表于由

Cygnus CHO HCP ELISA Kit, 3G (F550)中文说明书

This product has been depleted and replaced with CHO HCP ELISA Kit, 3G (F550-1)

We have resupplied F550 due to its capture and detection antibody stock depletion.

该产品已用完并替换为 CHO HCP ELISA Kit, 3G (F550-1)
由于 F550 的捕获和检测抗体库存耗尽，我们已重新供应。 如果您有任何问题或需要进一步帮助。

Product Information
Product Type: ELISA Kit
Storage: All kit reagents 2°C to 8°C
Target Expression System: CHO
Species Group: Mammalian
Species: Chinese hamster

产品信息
产品类型：ELISA 试剂盒
储存：所有试剂盒试剂 2°C 至 8°C
目标表达系统：CHO
物种组：哺乳动物
种类：中国仓鼠

Description

Important Change Notification Memo: CHO HCP ELISA Kit, 3G Resupply

New CHO HCP ELISA Kit, 3G, Item Number F550-1 now available

This CHO HCP 3rd Generation ELISA Kit uses a more broadly reactive antibody than our earlier kits and incorporates a number of other improvements for the detection of CHO HCPs. The “CHO 3G” ELISA is more sensitive than previous kits, able to detect HCPs in the range of 100 parts per billion for a variety of antibodies and other therapeutic proteins expressed in CHO. It has been extensively qualified with a large number of drug substances and in-process samples. This data indicates the kit is truly a generic method that can likely be validated as not only a process development tool, but in most cases as a lot release test, eliminating the need to develop a custom or process specific assay. The antibody has been evaluated for reactivity to individual HCPs using the conventional 2D Western Blot as well as a method we have shown to be superior to 2D WB, which we call AAE, Antibody Affinity Extraction. AAE demonstrated the antibody is reactive to more than 1000 individual HCPs from conditioned media and cell lysates in both a CHO-S strain as well as a K1 strain. These 1000+ HCPs represent more than 98% of the total mass of protein as indicated by protein detection methods orthogonal to ELISA. As such, this antibody may overcome concerns about missing any significant individual HCPs. This ELISA is also more robust than the earlier kits showing less sample matrix interference and improved dilution linearity. If you have found the F015 and CM015 kits lacking in any way meeting your HCP detection needs, or if you are considering the need for a process-specific assay, we recommend you evaluate this 3rd Generation CHO HCP ELISA kit.

描述
重要变更通知备忘录：CHO HCP ELISA 试剂盒、3G 补给

新的 CHO HCP ELISA 试剂盒，3G，货号 F550-1 现已上市

此 CHO HCP 第三代 ELISA 试剂盒使用比我们早期试剂盒更广泛的反应性抗体，并结合了许多其他改进来检测 CHO HCP。 “CHO 3G” ELISA 比以前的试剂盒更敏感，能够检测 CHO 中表达的各种抗体和其他治疗性蛋白的十亿分之 100 范围内的 HCP。它已通过大量原料药和在制品样品进行了广泛的鉴定。该数据表明该试剂盒确实是一种通用方法，不仅可以作为工艺开发工具进行验证，而且在大多数情况下可以作为批量放行测试，从而无需开发定制或工艺特定的检测方法。已使用传统的 2D Western Blot 以及我们已证明优于 2D WB 的方法（我们称之为 AAE，抗体亲和提取）评估了该抗体对单个 HCP 的反应性。 AAE 证明该抗体对来自 CHO-S 菌株和 K1 菌株的条件培养基和细胞裂解物的 1000 多个单独的 HCP 具有反应性。与 ELISA 正交的蛋白质检测方法表明，这 1000 多个 HCP 占蛋白​​质总质量的 98% 以上。因此，这种抗体可以克服对遗漏任何重要个体 HCP 的担忧。这种 ELISA 也比早期的试剂盒更稳健，显示出更少的样品基质干扰和改进的稀释线性。如果您发现 F015 和 CM015 试剂盒在任何方面都无法满足您的 HCP 检测需求，或者如果您正在考虑需要特定过程的检测，我们建议您评估这款第三代 CHO HCP ELISA 试剂盒。

Kit Components 试剂盒组成
Anti-CHO:HRP Conjugate, 3G
CHO HCP Standards Set, A-F, 3G
Stop Solution
TBS Wash Concentrate, 20X
TMB Substrate for ELISA
Anti-CHO Coated Microtiter Strips

Product FAQs 产品问与答

Why Perform Dual Wavelength Analysis?

The protocols in our ELISA kits recommend the use of dual wavelength analysis for microtiter plates readers appropriately equipped. For alkaline phosphatase – PNPP based assays the two wavelengths are 405 nm and 492 nm. For horse radish peroxidase – TMB based assays the wavelengths are 450 nm and 630 nm. In both assay types the first wavelength listed, also termed the “test wavelength”, is critical and thus your microtiter plate reader should be equipped with the appropriate 405 nm and 450 nm filters. It is not absolutely necessary to use dual wavelength analysis with any of our assays and thus the second wavelength (492 nm and 630 nm – also called the “reference wavelengths”) are optional. In theory, the use of dual wavelength analysis should provide better precision. Microtiter plate readers with the appropriate software will automatically subtract the reference wavelength absorbance from the test wavelength absorbance. In theory dual wavelength analysis can help to overcome any non-wavelength specific imperfections in the plate. In practice, because the optical quality of our microtiter plates is excellent, there is usually no significant statistical improvement in the data by subtracting out the reference absorbance from the test absorbance. Most plate readers are equipped to perform dual wavelength analysis. Since the reference wavelength is not critical, microtiter plate readers with reference filters close to those we recommend can be substituted. For example, you may use a 490 nm or a 500 nm filter in place of the 492 nm or a 600 nm or 650 nm filter in place of the 630 nm filter.

为什么要进行双波长分析？
我们的 ELISA 试剂盒中的方案建议对适当配备的微量滴定板读数器使用双波长分析。对于碱性磷酸酶 – 基于 PNPP 的分析，两个波长是 405 nm 和 492 nm。对于辣根过氧化物酶 – 基于 TMB 的检测，波长为 450 nm 和 630 nm。在这两种检测类型中，列出的第一个波长（也称为“测试波长”）至关重要，因此您的微量滴定板读数器应配备适当的 405 nm 和 450 nm 滤光片。在我们的任何检测中使用双波长分析并不是绝对必要的，因此第二个波长（492 nm 和 630 nm – 也称为“参考波长”）是可选的。理论上，使用双波长分析应该提供更好的精度。带有适当软件的微量滴定板读数器会自动从测试波长吸光度中减去参考波长吸光度。理论上，双波长分析可以帮助克服印版中任何非波长特定的缺陷。在实践中，由于我们的微量滴定板的光学质量非常好，从测试吸光度中减去参考吸光度通常不会对数据进行显着的统计改进。大多数读板机都配备执行双波长分析。由于参考波长并不重要，因此可以替换带有接近我们推荐的参考滤光片的微量滴定板读数器。例如，您可以使用 490 nm 或 500 nm 滤光片代替 492 nm 或 600 nm 或 650 nm 滤光片代替 630 nm 滤光片。

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Cygnus CHO HCP ELISA Kit (F015)试剂盒说明书

发表于由

Cygnus CHO HCP ELISA Kit (F015)试剂盒说明书

Cygnus试剂盒Cygnus technologies热销产品
Cygnus热销产品：cygnus f975、cygnus f410检测试剂盒、cygnus f550
品牌商名称：cygnus
公司官网：

Product Information

Product Type:ELISA Kit
Storage:All kit reagents 2°C to 8°C
Target Expression System:CHO
Species Group:Mammalian
Species:Chinese hamster
Assay format:96 Well Plate
Time to result:~3 hrs. 50 min. or ~5 hrs. 50 min
LOD:400 pg/mL
LLOQ:~4 ng/mL , or ~1 ng/mL
Recommended Diluent:I028

Description

The antibodies in this kit were generated against and affinity-purified from a cell lysate of CHO cells grown in serum supplemented media.

All three Cygnus CHO HCP kits recognize a vast majority of the same HCPs, but because the potential exists that the quantitative value reported for a given sample type may differ between the kits, we cannot predict which kit will be most suitable for your applications. Formal qualification must be performed on each different product to determine which of the three kits is best. For labs looking at CHO HCP impurities for the first time, use our CHO HCP ELISA, 3G (F550). If this method proves inadequate, then suggest evaluate CHO HCP kits CM015 and F015. Please use Sample Diluent, Item No. I028, with these kits; available separately.

描述
该试剂盒中的抗体是针对在补充有血清的培养基中生长的 CHO 细胞的细胞裂解物产生并亲和纯化的。

所有三个 Cygnus CHO HCP 试剂盒都可以识别绝大多数相同的 HCP，但由于可能存在针对给定样品类型报告的定量值可能因试剂盒而异，我们无法预测哪种试剂盒最适合您的应用。 必须对每种不同的产品进行正式鉴定，以确定三个套件中的哪一个是最好的。 对于首次检测 CHO HCP 杂质的实验室，请使用我们的 CHO HCP ELISA, 3G (F550)。 如果这种方法被证明不合适，那么建议评估 CHO HCP 试剂盒 CM015 和 F015。 请在这些套件中使用样品稀释剂，货号 I028； 可单独购买。

Kit Components 试剂盒成分：
Anti-CHO:Alkaline Phosphatase Conjugate
CHO HCP Standards Set, A-F
TBS Wash Concentrate, 20X
PNPP Substrate
Anti-CHO Coated Microtiter Strips

Product FAQs  产品问与答：

  • Can the ELISA Protocol in the Product Insert be Modified?

    The assay protocol recommended in the kits’ product insert have been developed with consideration given to typical limits of detection required in bioprocess impurity analysis. The assays are very robust with respect to protocol options and thus it is possible to modify the protocol to achieve performance parameters more optimal for your analytical needs. Sample volume, incubation times, and use of various sequential (forward or reverse sequential) schemes can lead to significant changes in sensitivity, reduction of non-specific sample matrix affects, or greater upper analytical range. If you change the protocol, it will be necessary to qualify that those changes achieve acceptable accuracy, specificity, and precision. Please refer to the section below on “How to Qualify HCP & Impurity Assays.” For advice on how best to modify an assay to meet your objectives you are encouraged to contact our Technical Services Department.

    产品插页中的 ELISA 方案可以修改吗？
    试剂盒产品插页中推荐的分析方案是在考虑到生物过程杂质分析所需的典型检测限的情况下开发的。 这些分析在方案选项方面非常稳健，因此可以修改方案以实现更适合您的分析需求的性能参数。 样品体积、孵育时间和各种顺序（正向或反向顺序）方案的使用会导致灵敏度显着变化、非特异性样品基质影响的减少或更高的分析范围。 如果您更改协议，则有必要确定这些更改达到可接受的准确性、特异性和精密度。 请参阅下面的“如何鉴定 HCP 和杂质检测”部分。 如需有关如何最好地修改检测以达到您的目标的建议，我们鼓励您联系我们的技术服务部门。

    Calibration of HCP assays

    The absolute quantitation of HCP assays is exceedingly difficult for several reasons. First of all, there is no recognized reference preparation of HCP against which we can calibrate our assays. While ELISA is inherently a quantitative method when applied to a single analyte, ELISAs that attempt to measure simultaneously all of the hundreds of potential HCP impurities in the same well using a single reporter/detector system are at best semi-quantitative assays. Many arbitrary choices and assumptions are used when preparing anti-HCP antibodies and later the choice of material to use when preparing “standards”.

    How to obtain the HCP material for immunogen is the first choice that must be made.

    • Do we use a null cell line or a mock transfected cell line or one with the actual product plasmid and what differences in HCP might we see from each? 
    • At what point in the purification process do we obtain the HCPs for the immunogen or standards?

    In almost every case the array and relative concentrations of HCPs in final product are different from the HCP in the ELISA standards.

    • How does one assign a total HCP concentration to an indeterminant mixture of many proteins with different molecular weights?
    • What effect will the different affinities of antibodies to various HCPs as well as the different concentrations of those antibodies have on the ability of the assay to be quantitative?
    • How do we know that we have antibody to all the HCPs present in a given sample type? 

    All of these questions and arbitrary choices mean HCP assays will at best be semi-quantitative methods capable of making only relative estimates of HCP concentrations from one sample to the next. We estimate the potential error in reporting an HCP level in a sample that has a different array of HCPs from the standards to be as high as 4-fold even if you have a very good broadly reactive antibody. The commonly expressed theoretical concern is that HCP assays might under-estimate results due to incomplete coverage of all HCPs. In reality, the quantitative errors in HCP assays due to the arbitrary choices and fundamental limitations of the method as discussed above can result in either over-estimation or under-estimation and tend to do so to about the same degree. In our experience, a well generated and affinity purified antibody will react to more than 70% of individual HCPs as demonstrated by traditional 2D Western blot correlated to silver stain. What is more important than the number of individual proteins with antibody reactivity, is the total mass of those proteins that are detected. In our experience and as you might expect from theoretical considerations, the proteins in highest concentration have the best chance of generating an antibody. As such, an antibody with about 70% reactivity to an individual HCP will react with those proteins that account for more than 95% of the total mass of HCP. Given this level of uncertainty in the absolute HCP concentration, the most important criteria by which we can judge any HCP assay is on other objective parameters by which any analytical method should be qualified or validated. Those criteria include specificity and accuracy as demonstrated by sample dilution linearity and spike recovery experiments, precision, robustness, and sensitivity. Provided the assay has sensitivity to detect at least a relative portion of the HCP in your final drug substance and the assay also meets the other objective analytical parameter specifications, such an assay is a valuable analytical method capable of demonstrating process control and reporting relative levels of HCP contamination from lot to lot as a release test.

    Due to the impracticality of obtaining real final product HCPs that co-purify with product down to the final step, most of our HCP assays will utilize a source of HCPs from very upstream in the purification process. Those HCPs typically do not come from the actual product cell line but rather a null cell or mock transfected cell line. Once we have decided on the source material for the kit standards we first perform some partial purifications to remove non-HCP materials such as growth media additives, buffer salts and extraction reagents. Our initial approach to calibrate this processed material is to simply perform a BCA total protein assay using bovine serum albumin (BSA) as an arbitrary standard. When standards made with the HCP material calibrated by BCA give reasonable “stoichiometric agreement” with the amounts of antibody used in the ELISA then we feel the calibration by BCA is good enough. What is meant by “stoichiometric agreement” is that we know how much antibody is used in the ELISA. It is the quantity of antibody that actually dictates the analytical range and dose response curve of the ELISA. If we assume an average molecular weight for the total HCPs, then we can reasonably estimate HCP concentrations across the valid analytical range of the assay. When the BCA assay concentrations do not reasonably approximate the ELISA stoichiometry, we process the HCP material further. Such processing involves various purification steps to remove components registering in the BCA assay but that are in fact not HCP or at least not immunoreactive HCPs. This processing might also involve affinity purification against the anti-HCP antibody. The purification stops as soon as the BCA concentration gives a realistic stoichiometric agreement in the ELISA.

    HCP 检测的校准
    由于几个原因，HCP 测定的绝对定量非常困难。首先，没有公认的 HCP 参考制剂可以用来校准我们的检测。虽然 ELISA 在应用于单个分析物时本质上是一种定量方法，但尝试使用单个报告器/检测器系统同时测量同一孔中的所有数百种潜在 HCP 杂质的 ELISA 充其量是半定量分析。在制备抗 HCP 抗体时使用了许多任意选择和假设，然后在制备“标准”时选择使用的材料。

    如何获得免疫原的HCP材料是必须要做的第一选择。

    我们是使用无效细胞系还是模拟转染细胞系，还是使用带有实际产品质粒的细胞系？我们可以从中看到 HCP 的哪些差异？
    我们在纯化过程中的哪个阶段获得免疫原或标准品的 HCP？
    在几乎所有情况下，最终产品中 HCP 的阵列和相对浓度都不同于 ELISA 标准中的 HCP。

    如何将总 HCP 浓度分配给许多具有不同分子量的蛋白质的不确定混合物？
    抗体对各种 HCP 的不同亲和力以及这些抗体的不同浓度对测定的定量能力有什么影响？
    我们如何知道我们对给定样本类型中存在的所有 HCP 都有抗体？
    所有这些问题和任意选择意味着 HCP 测定充其量只能是半定量方法，只能对从一个样品到下一个样品的 HCP 浓度进行相对估计。我们估计，即使您拥有非常好的广泛反应性抗体，在 HCP 阵列与标准不同的样本中报告 HCP 水平的潜在错误也会高达 4 倍。普遍表达的理论担忧是，由于对所有 HCP 的覆盖不完整，HCP 检测可能会低估结果。实际上，由于上​​述方法的任意选择和基本限制导致的 HCP 测定中的定量误差可能导致高估或低估，并且倾向于以大致相同的程度这样做。根据我们的经验，与银染色相关的传统 2D 蛋白质印迹证明，良好生成和亲和纯化的抗体将与 70% 以上的单个 HCP 发生反应。比具有抗体反应性的单个蛋白质的数量更重要的是检测到的这些蛋白质的总质量。根据我们的经验以及您可能从理论上的考虑，最高浓度的蛋白质最有可能产生抗体。因此，对单个 HCP 具有约 70% 反应性的抗体将与那些占 HCP 总质量 95% 以上的蛋白质发生反应。鉴于 HCP 绝对浓度的这种不确定性水平，我们判断任何 HCP 测定的最重要标准是其他客观参数，任何分析方法都应通过这些客观参数进行鉴定或验证。这些标准包括由样品稀释线性和加标回收实验证明的特异性和准确性、精密度、稳健性和灵敏度。如果该测定对检测最终原料药中至少一部分 HCP 具有敏感性，并且该测定还符合其他客观分析参数规范，则该测定是一种有价值的分析方法，能够证明过程控制并报告 HCP 的相对水平。批次间 HCP 污染作为放行测试。

    由于获得与产品共同纯化直至最后一步的真正最终产品 HCP 是不切实际的，我们的大多数 HCP 测定将利用纯化过程中非常上游的 HCP 来源。这些 HCP 通常不是来自实际的产品细胞系，而是来自空细胞或模拟转染细胞系。一旦我们确定了试剂盒标准的来源材料，我们首先会进行一些部分纯化以去除非 HCP 材料，例如生长培养基添加剂、缓冲盐和提取试剂。我们校准这种加工材料的初始方法是使用牛血清白蛋白 (BSA) 作为任意标准简单地执行 BCA 总蛋白测定。当使用 BCA 校准的 HCP 材料制成的标准与 ELISA 中使用的抗体量给出合理的“化学计量一致性”时，我们认为 BCA 的校准已经足够好。 “化学计量一致性”的意思是我们知道在 ELISA 中使用了多少抗体。抗体的数量实际上决定了 ELISA 的分析范围和剂量反应曲线。如果我们假设总 HCP 的平均分子量，那么我们可以合理地估计有效分析范围内的 HCP 浓度的化验。 当 BCA 测定浓度不能合理地接近 ELISA 化学计量时，我们会进一步处理 HCP 材料。 这种处理涉及各种纯化步骤，以去除在 BCA 测定中登记但实际上不是 HCP 或至少不是免疫反应性 HCP 的成分。 该处理还可能涉及针对抗 HCP 抗体的亲和纯化。 一旦 BCA 浓度在 ELISA 中给出真实的化学计量一致，纯化就会停止。

    What is the Storage and Stability of ELISA Kits?

    Cygnus kits and reagents have been formulated to withstand shipment and/or temporary storage under ambient temperature conditions without any significant deterioration. Orders within North America are shipped next day delivery service without cold packs. International orders are shipped with cold packs to protect from extreme heat.  Although stability studies have demonstrated that Cygnus kits can be held several weeks at ambient temperatures without any significant deterioration, we recommend storage at 2-8°C upon receipt of the products.   Our components have been challenged at elevated temperature excursions, addressing concerns over extreme summertime temperatures, delays in shipping, custom clearances and/or refrigeration problems at the customer locations.

    Should you have concerns regarding the performance of kits that have been subject to temperature deviations, we recommend an analysis of your control samples and historical specifications that determine the integrity of the kit. If the curve absorbances, sensitivity, and controls are within range, then the kit is acceptable for use.

    ELISA 试剂盒的储存和稳定性如何？
    Cygnus 试剂盒和试剂经过精心配制，可在环境温度条件下经受运输和/或临时储存，而不会出现任何显着变质。北美地区的订单在没有冷包的情况下第二天发货。国际订单随附冷袋以防止过热。虽然稳定性研究表明 Cygnus 套件可以在环境温度下保存数周而不会出现任何明显的劣化，但我们建议在收到产品后将其储存在 2-8°C。我们的组件在高温偏移中面临挑战，解决了对夏季极端温度、运输延迟、海关清关和/或客户所在地制冷问题的担忧。

    如果您对受温度偏差影响的试剂盒的性能有疑虑，我们建议您分析您的对照样品和确定试剂盒完整性的历史规格。如果曲线吸光度、灵敏度和对照在范围内，则可以使用该试剂盒。

    Which Cygnus CHO HCP kit to use: F015, CM015, F550 or F550-1?

    Cygnus currently offers 3 ELISA kits to measure CHO HCPs. Kit F015, the first kit developed more than 18 years ago, utilized a mild lysate of washed CHO cells for the immunogen and for affinity purification of the antibody, as well as for kit standards. This mild lysis procedure generated an array of HCPs similar to those found in culture media after cells have been grown to densities and viabilities similar to product harvest. Cygnus continues to support this kit as many companies have qualified it for their process. However, for first time users we suggest you first try our F550-1 3rd Generation CHO ELISA kit as it has been qualified for many products and has proven to be a broadly reactive generic kit able to detect downstream HCPs in most processes.

    Kit CM015 was developed 16 years ago with the rationale that since most CHO expressed products are released into the growth media (conditioned media) an antibody and/or assay made to those HCPs found in conditioned media should be more specific than a cell lysate assay. However, the CM015 kit has been demonstrated to be more process specific and thus is not a generic kit that might be applied across most products and processes.

    The F550 3rd Generation kit used an even more reactive antibody than earlier kits and incorporates significant improvements in the assay methodology. The antibody used in that kit has been evaluated for coverage by orthogonal method such as Antibody Affinity Extraction (AAE) with 2D-PAGE/Silver Stain. The F550 kit, when supported by comprehensive qualification of the ELISA itself along with data from orthogonal methods like AAE and Mass Spectrometry, has been successfully used as a lot release test in several processes. Due to the depletion of anti-CHO HCP Antibody used in F550 kit, this kit has been replaced with the resupply F550-1 CHO HCP ELISA, 3G.

    Starting from January 1, 2021, the 3rd generation CHO HCP ELISA Kit, Item Number F550-1, replaced CHO HCP ELISA Kit, 3G, Item Number F550. Cygnus manufactured, characterized, and qualified large pools of the new reagents that replaced reagents used in F550 kit. The new antibodies were developed and purified in the same way as the original critical reagents in the F550 Kit. The coverage of the new antibodies to the CHO HCP antigen was determined to be ~86% by Antibody Affinity Extraction with 2D-PAGE Silver Stain and 97% by AAE with MS. The antibody in F550-1 kit are very similar to the antibody in the depleted F550 kit. More importantly, Cygnus Technologies has demonstrated the equivalency of the new antibodies (3G-0016-1-AF) supporting 3G CHO ELISA Kit (F550-1) using a panel of CHO samples from a number of independent biomanufacturing processes. Download Cygnus Case Study comparing reactivity of anti-CHO HCP Antibody from F550 (3G-0016-AF) and F550-1 (3G-0016-1-AF) to CHO HCPs.

    Contact our expert technical staff to determine if the F550-1 kit is satisfactory for your product and process or if a process-specific method is needed.

    使用哪个 Cygnus CHO HCP 试剂盒：F015、CM015、F550 或 F550-1？
    Cygnus 目前提供 3 种 ELISA 试剂盒来测量 CHO HCP。试剂盒 F015 是 18 多年前开发的第一个试剂盒，它利用洗涤过的 CHO 细胞的温和裂解物作为免疫原和抗体的亲和纯化以及试剂盒标准品。这种温和的裂解程序在细胞生长到与产品收获相似的密度和活力后，产生了一系列与培养基中发现的 HCP 相似的 HCP。 Cygnus 继续支持该套件，因为许多公司已经对其流程进行了认证。但是，对于初次使用的用户，我们建议您首先尝试我们的 F550-1 第三代 CHO ELISA 试剂盒，因为它已通过许多产品的认证，并且已被证明是一种广泛反应的通用试剂盒，能够在大多数过程中检测下游 HCP。

    试剂盒 CM015 是 16 年前开发的，其基本原理是，由于大多数 CHO 表达产物被释放到生长培养基（条件培养基）中，因此对条件培养基中发现的 HCP 进行的抗体和/或测定应该比细胞裂解物测定更具特异性。然而，CM015 套件已被证明更具工艺特异性，因此不是可应用于大多数产品和工艺的通用套件。

    F550 第三代试剂盒使用比早期试剂盒更具反应性的抗体，并在检测方法上进行了重大改进。该试剂盒中使用的抗体已通过正交方法评估覆盖率，例如使用 2D-PAGE/Silver Stain 进行抗体亲和提取 (AAE)。 F550 试剂盒在 ELISA 本身的全面鉴定以及来自 AAE 和质谱等正交方法的数据的支持下，已成功用作多个过程中的批放行测试。由于 F550 试剂盒中使用的抗 CHO HCP 抗体耗尽，该试剂盒已替换为补给 F550-1 CHO HCP ELISA, 3G。

    从 2021 年 1 月 1 日起，第三代 CHO HCP ELISA 试剂盒，货号 F550-1，取代了 CHO HCP ELISA 试剂盒，3G，货号 F550。 Cygnus 制造、表征和鉴定了大量新试剂，以取代 F550 试剂盒中使用的试剂。新抗体的开发和纯化方法与 F550 试剂盒中的原始关键试剂相同。使用 2D-PAGE Silver Stain 进行抗体亲和提取确定新抗体对 CHO HCP 抗原的覆盖率约为 86%，而 AAE 和 MS 的覆盖率确定为 97%。 F550-1 试剂盒中的抗体与耗尽的 F550 试剂盒中的抗体非常相似。更重要的是，Cygnus Technologies 使用来自多个独立生物制造过程的一组 CHO 样本证明了支持 3G CHO ELISA 试剂盒 (F550-1) 的新抗体 (3G-0016-1-AF) 的等效性。下载 Cygnus 案例研究，比较来自 F550 (3G-0016-AF) 和 F550-1 (3G-0016-1-AF) 的抗 CHO HCP 抗体与 CHO HCP 的反应性。

    请联系我们的专业技术人员以确定 F550-1 套件是否适合您的产品和工艺，或者是否需要特定工艺的方法。

Cygnus试剂盒Cygnus technologies热销产品

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Cygnus试剂盒Cygnus technologies热销产品

Cygnus热销产品：cygnus f975、cygnus f410检测试剂盒、cygnus f550

品牌商名称：cygnus
联系地址：4701 Southport Supply Rd., SE, Suite 7 Southport, NC 28461
公司官网：http://cygnustechnologies.com

Cygnus生物公司是一家专为疫苗生产企业、基因工程药企、研发部门及QA部门提供污染物检测产品的世界**的美国公司。

Cygnus公司产品主要包括：

检测宿主细胞蛋白残留和生物制品生产过程污染物(Elisa 试剂盒）；  检测并鉴定常用重组表达系统中的宿主细胞蛋白（WesternBlotting 试剂盒）为生物医药行业提供检测生物制品免疫原性的方法；检测微生物的抗体。

We offer a comprehensive menu of well-validated, convenient to use microtiter plate ELISA methods to detect Host Cell Proteins from specific recombinant expression systems and bioprocess contaminants used in culture media as well as transgenic expression systems in goats and cattle. We develop and routinely manufacture, by cGMP methods,  ELISA and Western Blot kits to contaminants specific to more than 50 different expression systems. Our extensive list of ancillary reagents is useful in developing and validating your product and process-specific assays.
Cygnus试剂盒Cygnus technologies热销产品

货号         中文名称
F230                     A549 宿主蛋白检测试剂盒
F510                     BHK 宿主蛋白检测试剂盒
F015                     CHO宿主蛋白检测试剂盒
CM015                 第二代CHO宿主蛋白检测试剂盒
F550                     第三代CHO宿主蛋白检测试剂盒
F650                     HEK 293 宿主蛋白检测试剂盒
F300                     MRC5 宿主蛋白检测试剂盒
F220                     NS/0 宿主蛋白检测试剂盒
F530                     PER.C6 细胞宿主蛋白检测试剂盒
F180                     SP 2/0宿主蛋白检测试剂盒
F500                     Vero 细胞 宿主蛋白检测试剂盒
F450                     荧光假单胞菌宿主蛋白检测试剂盒
F320                     金黄色葡萄球菌宿主蛋白检测试剂盒
F410                     E. coli 宿主蛋白检测试剂盒
F490                     乳酸乳球菌宿主蛋白检测试剂盒
F140                     毕赤酵母宿主蛋白检测试剂盒
F135                     酿酒酵母宿主蛋白检测试剂盒
F020                     SF9细胞宿主蛋白检测试剂盒
F240                     总羊奶蛋白残留检测试剂盒
F070                     牛IgG蛋白检测试剂盒
F290                     牛血清蛋白检测试剂盒
F030                     牛血清白蛋白检测试剂盒
F120                     牛转铁蛋白检测试剂盒
F210                     山羊IgG检测试剂盒
F055                     人白蛋白检测试剂盒
F165                     人IgA检测试剂盒
F160                     人总IgG检测试剂盒
F170                     人IgM检测试剂盒
F035N                  人转铁蛋白检测试剂盒
F040                     胰岛素检测试剂盒
F280                     超敏胰岛素检测试剂盒
F049                     小鼠总IgG检测试剂盒
F045                     小鼠IgG1检测试剂盒
F046                     小鼠IgG2a检测试剂盒
F047                     小鼠IgG2b检测试剂盒
F090                     小鼠IgM检测试剂盒
F050                     Protein A残留检测试剂盒
F050H                  Protein A残留检测试剂盒
F400                     Protein A残留检测试剂盒

Cygnus F975 宿主细胞蛋白检测试剂盒 Vero Cell 2G HCP ELISA KIT

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Cygnus F975 宿主细胞蛋白检测试剂盒 Vero Cell 2G HCP ELISA KIT

Description

Expression of viral vectors and vaccines in Vero cells is a cost-effective method for production of commercial quantities of a drug substance. The manufacturing and purification process of these products leaves the potential for impurities by HCPs from Vero cells. Such impurities can reduce the efficacy of the therapeutic or vaccine agent and result in adverse toxic or immunological reactions. Thus, it is desirable to reduce HCP impurities to the lowest levels practical.
This kit was developed using the antibodies that have been generated against and affinity purified using mild lysate of Vero cells. This simple to use, robust, and semi-quantitative ELISA is a sensitive and specific method to aid in optimal purification process development, process control, routine quality control, and product release testing. This kit is “generic” in the sense that it is intended to react with a majority of the HCPs that could pollute the product independent of the purification process.
This Vero Cell HCP ELISA has an LOD of ~1.4 ng/ml.

描述
在 Vero 细胞中表达病毒载体和疫苗是生产商业量药物的一种经济有效的方法。这些产品的制造和纯化过程留下了来自 Vero 细胞的 HCP 产生杂质的可能性。此类杂质会降低治疗剂或疫苗剂的功效并导致不利的毒性或免疫反应。因此，希望将 HCP 杂质减少到实际的最低水平。
该试剂盒是使用针对 Vero 细胞的温和裂解物产生并亲和纯化的抗体开发的。这种简单易用、稳健且半定量的 ELISA 是一种灵敏且特异的方法，有助于优化纯化工艺开发、工艺控制、常规质量控制和产品放行测试。该试剂盒是“通用的”，因为它旨在与大多数可能污染产品的 HCP 反应，而与纯化过程无关。
此 Vero Cell HCP ELISA 的 LOD 约为 1.4 ng/ml。