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 ELISA kits for Host Cell Protein Analysis

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Many recombinantly produced proteins are intended for use as therapeutic agents in humans and animals and therefore must be highly purified. The manufacturing and purification processes of these products leaves the potential for contamination by host cell proteins. Our ELISA kits are designed for the sensitive detection of host cell proteins from specific recombinant expression systems. 

Product

Catalog Number

Description

A549 HCP ELISA

F230

The kit is intended for measuring host cell proteins from the human cell line A549.
BHK HCP ELISA

F510

This kit is intended for use in determining the presence of host cell protein contamination in products manufactured by expression in BHK cells.  The antibodies have been generated against and affinity purified using mild lysate of BHK cells. The LOD for this assay is ~0.4 ng/mL.
CHO HCP ELISA

F015

This generic assay is intended for the ultra-sensitive detection of the majority of CHO HCP’s. This kit can be used for both process development as well as lot-to-lot release testing. The antibodies used in this kit were generated from a lysate of cells grown in serum supplemented and defined protein media. The lower limit of detection for this assay is ~400pg/mL.

CHO-CM HCP ELISA

CM015

This assay was developed to be more process specific than the generic assay mentioned above. This assay is intended for use on pharmaceutical products secreted into protein free CHO growth media. The antibody is raised against, affinity purified, and calibrated with HCPs typically found in protein free CHO conditioned media.  LOD is < 600 pg/mL.

E. coli HCP ELISA   (HRP)

 

F410

This new kit utilizes an HRP based detection system. The assay is rapid, more sensitive, and may show less interference from problematic sample types than the original ELISA kit, #F010. The antibodies and standards in this kit focus on the E. coli  strains DH5a and BL21. LOD is     200 pg/mL.

HEK 293 HCP ELISA

F150

This kit is designed to measure Human Embryonic Kidney 293 HCP contamination. The lowest limit of detection for this assay is less than 300pg/mL.

Lactococcus lactic HCP ELISA

F490

This kit has been specifically developed and validated for use in detecting L. lactic HCPs as contaminants in products produced by recombinant expression in Lactococcus lactic. This kit utilizes antibodies raised against and affinity purified from HCPs derived from L.lactic spent culture media. The LOD for this assay is ~0.125ng/mL.

MRC5 HCP ELISA

F300

 

This kit measures MRC5 host cell protein contamination in products manufactured by recombinant expression in MRC5 cells.

NS/0 HCP ELISA

F220

This kit measures mouse hybridoma cell line NS/0 HCP contamination.

Pichia pastoris HCP ELISA

F140

The lowest limit of detection for this assay is less than 300pg/mL.

P. fluorescens HCP ELISA

F450

This kit measures Pseudomonas fluorescens host cell protein contamination in products manufactured by recombinant expression in P. fluorescens cells.

Saccharomyces  cerevisiae HCP  ELISA  

F135

The sensitivity of this assay is ~400pg/mL and can be improved upon by extending various incubation times or sample size.

SF9  HCP ELISA

F020

This kit is intended for measuring HCP from Insect Cell Line SF9.

SP2/0 HCP ELISA

F180

This kit is designed to measure Host Cell Proteins from hybridoma cell line SP2/0. The sensitivity of this assay is ~1ng/mL.

Total Goat Milk Proteins ELISA

F240

This kit measures total goat milk proteins in transgenically expressed systems.
Vero cell HCP ELISA

F500

This kit is intended for use in determining the presence of host cell protein contamination in products manufactured by expression in Vero cells.  The antibodies have been generated against and affinity purified using mild lysate of Vero cells.  The LOD for this assay is             ~0.7 ng/mL.

  Specific antigen concentrates can be found here:

  Cygnus Technologies, Inc.  4701 Southport Supply Rd.,  SE,  Suite 7  Southport, NC 28461
  Phone: 910-454-9442   Fax: 910-454-9443   Email:
cygnustec@aol.com     

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