Shawn Fernando, Senior Researcher, Bioanalytical Development, Morphotek, Exton, PA, USA, presented ‘Development and Validation of a Pharmacokinetic Assay on the Gyrolab Platform for Use in Phase II/III Clinical Trials' at the North American Gyrolab Seminar, USA.
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The recent outbreak of the novel coronavirus disease (COVID-19) has resulted in a worldwide pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Efforts to slow the spread of the virus and to develop vaccines and treatments require SARS-CoV-2 antibody testing. To meet this need, we have developed a Gyrolab immunoassay for qualitative detection of total antibodies generated against the receptor binding domain (RBD) of the spike (S) protein of SARS-CoV-2 in human serum samples.
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.
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.
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.
Measuring anti-drug antibody (ADA) levels is an essential part of developing new biologics. The clinical implication of the presence of anti-drug-antibodies in treated patients may include allergic reactions, immune complex toxicity, autoimmune reactions and reduction of efficacy.
Recently regulatory agencies have lowered the sensitivity requirement for ADA detection, from 250-500 ng/mL to 100 ng/mL. To reach such sensitivity levels without affecting the assay drug tolerance, sample pre-treatment steps may be necessary. Gyrolab ADA Solution streamlines ADA assay workflows and automates acid dissociation steps to improve sensitivity and drug tolerance of ADA assays while reducing variability and saving time. ADA assays can also be developed using overnight incubation protocols to dissociate the drug-ADA complexes prior to determination of ADA levels in clinical samples using Gyrolab Bioaffy 200 or 1000 CD.
To meet the needs of immunogenicity evaluation during biotherapeutic development, we have developed Gyrolab protocols to determine ADAs in clinical or preclinical samples that have been treated with marketed biopharmaceuticals.