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New Products and Documentation


January 2017

MDCK and HeLa HCP ELISA Kits are now available!!


October 2016

Mark your calendars! 06DEC2016 @ 11:00am
Cygnus Technologies is sponsoring a free webinar:
"Improved Methods for Host Cell Protein Analysis"
click the link below to access the CHI site and register today!
http://www.healthtech.com/cygnus-technologies/improved-methods-for-host-cell-protein-analysis/


September 2016


New HCP ELISA Kits now available!!


MDCK and HeLa



March 2016


Multi-Method Analysis of your Host Cell Protein Impurities

Cygnus Technologies announces a testing/qualification service using a full repertoire of analytic methods to comprehensively characterize HCP content in downstream samples

Analytical methods:
* Analysis of your in-house process specific assay for Dilution Linearity
Confirmation of total HCP reported by your asssay as compared to proven generic/platform assays
* Use of Antibody Affinity Extraction (AAE), a method much superior to 2D Western blot, to determine Antibody Coverage to upstream HCPs and to fractionate individual HCPs in downstream samples
* Various modalities of Mass Spectrometry to first identify major HCPs and then quantify important targeted HCPs

Orthogonal methods analysis integration offers several benefits:
* Further validation of your HCP ELISA as a release test
* Justification for the use of an existing platform or generic assay, obviating the need to develop process-specific assays
* Indicate the need for other assays to quantify problematic individual HCPs
* Guide purification process developers in targeted removal of individual HCPs

Contact our Technical Service department to determine the types of orthogonal HCP analysis that meet your needs. Click on this link to read a technical article titled “Comprehensive Characterization of Host Cell Proteins” for a detailed discussion of the integration of orthogonal methods in HCP analysis.


New HCP ELISA Kit for human cell line CAP®

Cygnus Technologies and CEVEC are pleased to announce the availability of an ELISA kit to detect Host Cell Proteins from CEVEC's proprietary CAP® expression system. The antibody used in this kit has been characterized by our AAE method demonstrating very broad coverage to the majority of the CAP® proteome. The ELISA was developed and qualified to actual in-process and final drug substance samples. Subject to qualification by each lab, this assay should be useful as a process development and process monitoring tool for any product expressed in CAP® Go or CAP® GT expression systems. Catalog # F820. The CAP® word mark is a registered trademark of CEVEC Pharmaceuticals GmbH.





January 2015


New!! Protein A ELISA kit for quantitating JSR's JWT203 Protein A ligand


Now Available.... Amsphere Protein A JWT203 Mix-N-Go ELISA kit, Catalog #F740 is specific for use with JLS' Amsphere JWT203 Protein A ligand.  

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September 2014

Replacement Antibody Pool for CHO 3rd Generation ELISA kit, Cat. # F550

Cygnus has manufactured, characterized and qualified a large pool of new antibody that will replace the current lot of antibody. This new antibody was generated from a pool of 5 goats using the same lot of CHO HCPs obtained from conditioned media as was used to generate the current lot of antibody. Furthermore, it has been affinity purified by the same procedure using the same HCP preparation. As such, we expect the new antibody to be similarly reactive to a broad range of CHO HCPs. Western blot of PAGE fractionated media HCPs shows very broad reactivity not significantly different from the current antibody. More importantly, Cygnus Technologies has evaluated this new antibody in the 3G CHO ELISA using a panel of CHO samples obtained from several customers. While most of the samples in our test panel did not show a significant difference between antibodies, some samples showed up to a 2-fold higher value and others showed about a 2-fold lower value. Such differences are expected and should not be concluded to mean one assay is more sensitive or more broadly reactive.

We suggest at least the following studies be performed to qualify the new antibody:

       1. Establish the mean and range for your controls with the new kit. This may be different (higher or lower) relative to the 1st antibody. To avoid failing runs due to controls 'out of specification' it is necessary to establish a new range. If you use other curve parameters such as ODs as an indirect specification, these too may require a new range to be established.

       2.  Test previous in-process and drug substance samples with kits using the new antibody to determine if there is a consistent and significant difference and bias (higher or lower values) from the kit using the old antibody.

       3.  If there are significant differences in historical samples, we suggest performing dilutional linearity and spike and recovery studies with the new antibody to assure accuracy and specificity.

       4.  If you are using the F550 kit for lot release testing, determine what if any effect differences in control and sample values will have on your release criteria and document those changes.

Kits with the new antibody are available so that you can begin comparison studies. Please specify when ordering that you require the kits with new anibody since the catalog number will stay the same as F550.

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March 2014

Now Available:

Mix-N-Go Protein A ELISA kits for detection of Natural and UnNatural constructs.

These new kits offer new enhancements over our current Protein A ELISA product line:

No sample boiling is needed to dissociate Protein A from your samples.
New protocol eliminates centrifugation of your samples.
Total processing and assay time is reduced by over 1 hour.
Eliminates Ab interference seen in most Protein A assays.
Specific standards for various constructs of Protein A.
Very sensitive, kits detect Protein A levels to <100pg/mL.

These kits utilize a Mix-N-Go Denaturing Buffer used to treat samples for 5-10 minutes at room temperature. Treated samples are transferred to the microtiter plate with final results available in 90 minutes. 
 
   
      ♦ Cat #F600, Mix-N-Go Protein A ELISA kit for Natural Protein A Constructs.   
This kit is designed to perform with most natural and recombinant Protein A constructs that maintain the general Protein A size and activity.

              Cat #F610, Mix-N-Go Protein A ELISA kit for UnNatural Protein A Constructs
 This kit uses recombinant Protein A calibrated against the construct of MabSelect SuRe™. This kit  should work against unnatural lower molecular weight constructs of Protein A.

 


April 2013

Cygnus has moved operations to a new 10,000 sq.ft. energy efficient facility in Southport, NC.  The new facility will expand the current operations, increase operational efficiency and control to continue to excel in the global biotechnology market. Cygnus is dedicated to provide top-notch products and the highest level of scientific support, while enhancing modern technology to make the world a better place.


November 2012

NEW.......Protein A ELISA kit, Catalog #F400Z for use with problematic samples.

This kit uses a new conjugate, Cat # F401Z, with a special formulation made available for problematic samples that do not yield acceptable recovery of Protein A in the F400 kit.


October 2012


July 2012

2nd Generation Pichia pastoris HCP ELISA kit

This kit employs our latest advances in HCP analysis and is more specific than our 1st Generation, F140 Pichia pastoris HCP ELISA kit.
 


June 2012

PCR kits

DNA Amplification kits in both deep well and tube format are now available for CHO and E.coli. The kits contain the reagents for DNA extraction as well as calibrated DNA standards and validated primers for DNA amplification. Residual DNA can be confidently measured to 1 part per billion levels.


April 2012

Residual Host Cell DNA kits in tube format

Residual Host Cell DNA kits are now available in tubes for users who do not have the ability to centrifuge deep well plates. CHO, E.coli, and NS/0 residual host cell DNA kits utlize PicroGreen® dye and include DNA Extraction reagents and cell line specific calibrators.


February 2012

Residual Host Cell DNA kits in deep well format.

Residual Host Cell DNA kits are now available in a deep well format. CHO, E.coli and NS/0 residual host cell DNA kits are a dye binding assay utilizing PicoGreen® dye. The kits utilize our DNA Extraction method and include cell line specific calibrators.


January 2012

DNA Extraction Kits

Two formats are available for our DNA Extraction Kits.  The DNA extraction can take place in an easy to use deep well extraction plate or in common sterile microfuge tubes. The high throughput method uses a deep well extraction plate with time to completion in less than 2 hours. The superior co-precipitating agent used in the kit ensures that pellets remain seated until ready for use  thereby minimizing additional centrifugation. 


April 2011

Improved Sample Treatment Procedure for Protein A ELISA, #F400.

This new high throughput sample treatment procedure reduces tedious pipetting while increasing throughput of the sample processing step. Included with the kit is the Sample Treatment Plate which minimizes problems associated with handling multiple microfuge tubes.


December 2010

Improved Insulin ELISA kit, Cat# F040.

Two more standards have been added to the standards set to include 2ng/mL and 10ng/mL. The kit will now better conform to analytical guidelines suggesting the use of at least 6 standards.


January 2010

HEK 293 HCP ELISA kit - 2nd Generation, Cat# F650.

This new and improved HCP ELISA kit uses antibodies derived from the same pool of goat anti-HEK antiserum used in the 1st generation kit, however this antiserum has now been affinity purified with new and more representative preparation of HCPs typically found in virus, vaccine, and recombinant proteins products.


September 2009

CHO HCP ELISA kit - 3rd Generation, Cat# F550.