David Gordon is manager at the department of immunoassays and biopharmaceuticals for preclinical biosciences at the Aptuit facility in Verona, Italy. With 20 years of experience in the CRO/pharma industry, David immediately grasped the advantages of Gyrolab® technology at the theoretical level and soon appreciated the strengths of the system in practical terms — rapid turnaround, ease of use, and the advantages that immunoassays at nanoliter scale bring. “With increasing regulatory pressure to do more than just bioanalysis of samples, it’s a major advantage being able to run immunoassays on a few microliters of sample, leaving the rest for other studies. This is a distinct advantage over the 50 microliters or so consumed by regular ELISA.”
Aptuit is currently using Gyrolab technology to develop an assay to quantify a protein drug under development by a client. The assay will be validated for regulatory studies. Future plans for Gyrolab workstations include more applications in preclinical and clinical work, including ADA, and may also include the support of commercial manufacturing in other parts of the company. “Aptuit can now provide commercial and post-commercial production of biological drugs at our U.S. and UK facilities. Gyrolab technology clearly has potential here, in the measurement of process impurities in the production of biological drugs at the GMP level.”
Aptuit present themselves:
Founded in 2004, Aptuit is a pharmaceutical services company that delivers early to mid-phase drug development solutions by applying scientific excellence, outstanding service and a team of some of the foremost scientific professionals in the industry.
These drug discovery and development professionals offer proven experience in key therapeutic areas. They share a legacy of success, having advanced a large number of molecules efficiently, expeditiously and economically, from early discovery through clinical development with low attrition rates.
It is our uncommon expertise that allows Aptuit to identify the unexpected, mitigating risks and maximizing promising possibilities, ensuring exceptional results through an open, transparent climate of trust that our clients can count on.
Find out more at www.aptuit.com.
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.
