Focusing on Ligand Binding Assays, SYRINX Bioanalytics prides itself in being able to analyze biotherapeutics using a wide selection of platforms, including Gyrolab xP workstation. The low sample consumption combined with high sensitivity and broad dynamic range of Gyrolab gives them a critical edge when running preclinical studies. The CRO has a strong focus on the science. As Dr. Timo Piironen, Scientific Director and Adjunct Professor says, “We have a really good crew on board with excellent scientific credentials and we are used to solving very complex problems”.
SYRINX Bioanalytics acquired Gyrolab in 2010, after being given the opportunity to evaluate the performance of their own assays on the platform at the Gyros facility in Uppsala – an opportunity they greatly appreciated. “We are proactive and we feel that the acquisition of Gyrolab gives us an edge in differentiating ourselves from other CROs”. About one third of their mid-size and large pharma clients have Gyrolab.
The team at SYRINX Bioanalytics already had a lot of experience with high performance techniques such as DELFIA, and their benchmark studies showed that Gyrolab could match the sensitivity and broad dynamic range of the DELFIA technology, and with much lower sample consumption. Timo sees the low sample consumption as the main advantage of Gyrolab, especially in preclinical studies. “For example, we developed an ADA assay that enabled us to complete a preclinical study using individual rat samples without pooling. In these types of study we need to run samples a few times through the assay – for screening, confirmation and then titer determination – so low sample consumption is critical.” SYRINX Bioanalytics also appreciates the automation of Gyrolab and the fast assay development time. They develop assays from scratch and also transfer them from clients.
Timo concludes by saying that it would be a real boost if Gyros could offer panels of biomarker kits for preclinical work, something that would often smoothen the path forward for their clients. SYRINX Bioanalytics has had a very positive relationship with Gyros right from the start. “Gyros is a very reliable partner and we have received excellent scientific support”.
SYRINX Bioanalytics present themselves:
SYRINX Bioanalytics is a Contract Research Organization (CRO) offering a large variety of modern immunoassay techniques for the bioanalysis of
Syrinx Bioanalytics performs bioanalytical studies in compliance with GLP, GCP and GMP - the GLP laboratory (since 1991) is continuously striving to fulfill the latest guideline and white paper requirements.
Our values:
Find out more at www.syrinxbioanalytics.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.