SYRINX has extensive experience of developing new methods using state-of-the-art immunological and cell based techniques for pharmacokinetic (PK) sample analysis.
Our laboratory employs various plate and cellbased technologies, such as TR-FIA, ECL, AlphaLISA, iLITE, TR-FRET, RIA, SPR and ELISA, to assess the immunogenicity of biological drugs and vaccines.
Patient monitoring services are now available!
Concentration/activity analysis and immunogenicity testing using the iLite™ technology platform.
SYRINX Bioanalytics is a Contract Research Organization (CRO) offering a large variety of modern immunoassay techniques for the bioanalysis of Biologicals, Biosimilars, Anti-drug antibodies (immunogenicity testing) and Biomarkers.
SYRINX performs bioanalytical studies in compliance with GLP/GCP and supports GMP analysis for batch release and stability studies.
We are continuously striving to fulfil the latest guideline and white paper requirements offering innovative approaches utilising our strong scientific expertise and responsive communication with the focus on quality and on time delivery.
SYRINX Bioanalytics is included in the OECD principles of good laboratory practice (GLP) and EU good manufacturing practice (GMP analytics) monitoring programs.
SYRINX Bioanalytics offers a wide range of state-of-the-art assay techniques ideal for the bioanalysis of biologicals/biosimilars, anti-drug antibodies, vaccines and biomarkers.
SYRINX is a member of the European Bioanalysis Forum (EBF) together with more than 50 other Pharma and CRO companies.
SYRINX will attend the "EBF 12th Open Symposium: Imagine! - A New Bioanalytical Earthrise" 20-22 Nov 2019 in Barcelona, Spain.
SYRINX attended the "EBF - Focus Workshop: Biomarker Assay Validation – Bringing Context of Use into practice" 19-20 Sep 2019 in Malaga, Spain.
SYRINX attended the EBF Workshop "ICH M10 - Public consultation & Industry Feedback Towards a Science based Global Bioanalytical GuidelineICH M10 - Public consultation & Industry Feedback Towards a Science based Global Bioanalytical Guideline" 20-22 May 2019 in Barcelona, Spain.
SYRINX attended the "9th Gene Quantification Event qPCR dPCR & NGS 2019" 18-22 Mar 2019 in Freising-Weihenstephan, Germany.
SYRINX attended the "Pharma Outsourcing" event 12 Dec 2018 in Stockholm, Sweden.
Immunogenicity analysis - determination of cut points. We use in-house validated MS Excel-templates for statistical evaluation of cut points according to Shankar et al. (Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products: J. Pharm. Biomed. Anal. 2008, 48/5: 1267-81) and Devanarayan et al. (Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points: AAPS Journal 2017, 19/5: 1487–1498). More info can be requested by sending E-mail enquiry.