Gyrolab Assay Protocols

Gyrolab systems are supported by an increasing range of ready-to-use kits, and yet remain as open systems for enabling the in-house development and evaluation of high-performance custom immunoassays. To help you accelerate development of commonly used immunoassays, ready-to-use and robust Gyrolab assay protocols are now available for use.

These protocols provide carefully tested Gyrolab assay methods specifying the assay design, CD type, antibody reagents, Rexxip buffer, dilutions, and needle wash buffers. Assay performance data generated over 3 runs is also provided that demonstrates the high-quality results attained. The advantages of initiating assay development utilizing these protocols include accelerating bioanalytical assay development, reducing time to market, and increasing productivity while maintaining high-quality assay data.

Visit this page often, as new protocols will be added on a continuous basis

mAbs/Biosimilars

As biologic drugs come off-patent and biosimilar versions become available it is vital to ensure that the biosimilars have similar PK, efficacy, and safety profiles to their branded equivalents. The equivalence of biosimilars is a point of concern since the tight relationship between structure and function of biologics means that pharmacology can be affected by even minor changes during the manufacturing process. We have therefore developed a set of robust Gyrolab PK assay protocols to support the development of biosimilars from nonclinical to human clinical studies.


DOWNLOADActemra® (tocilizumab) PK Assay

DOWNLOADAtezolizumab PK Assay

DOWNLOADAvastin® (bevacizumab) PK Assay

Enbrel® (enteracept) PK Assay DOWNLOAD

DOWNLOADErbitux® (cetuximab) PK Assay

DOWNLOAD

Herceptin® (trastuzumab) PK Assay

DOWNLOADHumira® (adalimumab) PK Assay

DOWNLOADHumira® (adalimumab) Bridging PK Assay

DOWNLOADKeytruda® (pembrolizumab) PK Assay

DOWNLOADKineret® (anakinra) PK Assay

DOWNLOADNeulasta® (pegfilgrastim) PK Assay

MabThera® (rituximab) PK Assay DOWNLOAD

DOWNLOADOpdivo® (nivolumab) PK Assay

DOWNLOADOrencia® (abatacept) PK Assay

DOWNLOADRemicade® (infliximab) PK Assay

Remsima(infliximab) PK AssayDOWNLOAD


Simponi® (golimumab) PK AssayDOWNLOAD

 

Bioprocess impurity analysis

A key requirement in biopharmaceutical manufacturing is the development of a robust, sensitive, and high-quality bioanalytical method for the detection of impurities that inevitably carry over from the production process. These impurities can originate from the culture media or additives, from the purification process such as protein A leaching from a purification column, or from the host cells. The presence of host cell proteins (HCPs) is of particular concern, as these contaminants pose an immunogenicity reaction risk to the patients.

To assist with the development of immunoassays for bioprocess impurity analysis, we have developed robust assay protocols to determine process-related impurities in bioprocessing samples.

DOWNLOADHuman Transferrin Impurity Assay

DOWNLOADInsulin impurity Assay

DOWNLOADPLBL2 Impurity Assay

 

Biomarker analysis

Protein biomarkers are utilized in all phases of the drug development process from discovery to clinical studies to evaluate a drug’s effectiveness or potential toxicity. Immunoassays remain the most selective, specific, and sensitive method to determine protein biomarker levels. However, the development of these assays can be challenging due to the high sensitivity required and serum matrix interference.

We have developed immunoassays with supporting data to provide a foundation to speed up your biomarker immunoassay development.

DOWNLOADGLP-1 Active Assay

DOWNLOADGLP-1 Total Assay

DOWNLOADClusterin Assay

DOWNLOADRat KIM-1 Assay

 

Would you like to submit a suggestion for a Gyrolab Assay? Your suggestion will be added to our new Gyrolab Assay development list

Suggest new Gyrolab Assay