Bioanalytical services
GLP/GC(L)P and non-GLP services
Microcoat offers GLP/GC(L)P and non-GLP services in the fields of immunodiagnostics, pharmacology, clinical chemistry, clinical safety, biological safety and biomarker testing to pharma and life science industry worldwide. Our companion diagnostic activities support your early clinical development, pre-clinical, clinical and follow up studies. Long-term experience with first generation biopharmaceuticals enables us to effectively support the expanding area of biosimilars and „biobetters“.
Microcoat provides bioanalytical services including
Biomarker quantification
Biomarkers are increasingly important in the pharmaceuticals development and have a wide range of potential clinical utilities. In particular as indicators of safety and efficacy in early phase development. Microcoat´s expertise lies in the custom development of assays either de novo or by adaption and optimization of existing formats. Customers rely on our experience in detection and quantitation of biomarkers in a wide variety of matrices. Benefit from our broad technology portfolio. Planning and performing the analysis of all paramters in one hand allows us to get the most out of your samples.
Planning and performing the analysis of all paramters in one hand allows us to get the most out of your samples.
Our portfolio includes
Biosimilars Support
By the end of 2014, 19 Biosimilar products were approved by the European medicines Agency. The global market for Biosimilars will continue to rapidly grow over the next years. By definition a Biosimilar is a product with high similarity in quality, safety and efficacy to a reference product. Besides extensive structural and functional characterization, assessment of immunogenicity and pharmacokinetics and/or pharmacodynamics data are mandatory for the application of the product.
Microcoats bioanalytical service offers a safety-package including immunogenicity and PK/PD assays for the support of preclinical and clinical development of Biosimilars. Our customers benefit from over 8 years of experience in Biosimilar testing.
Our portfolio includes
Immunogenicity
Generation of anti-drug antibodies (ADA) against a therapeutic protein can cause allergic or anaphylactic reactions, reduction in efficacy or induction of autoimmunity. Therefore, immunogenicity testing is a mandatory regulation in pre-clinical and clinical development of biopharmaceuticals. Studies on immunogenicity of therapeutically used peptides, proteins or antibodies are often indispensable in determining bioequivalence, biosimilarity or biocomparability.
Our portfolio includes
Sample measurement
Serving the needs of companies in the fields of pharmaceutical and diagnostic development for outsourcing of routine sample measurement we offer the analysis of non-clinical and clinical samples. Customers save time and resources by the use of our Know-How and technical equipment.
We measure samples coming from R&D projects over pre-clinical and clinical studies to in-process controls and release procedures in our Biosafety Level 2 lab.
Our portfolio includes
PK assays
Pharmacokinetics (PK) describes how a specific drug is affected and processed by the body after administration. Pharmacokinetic properties of drugs may be affected by elements such as the site of administration and the dose of administered drug. PK data help to select the dose for preclinical and clinical studies and are also required for comparative analysis of originator and biosimilar products.
The PK analysis of a biological drug in different matrices is an essential step in medicinal drug development. Immunoassays using different assay formats and assay read outs can be used for the quantitative drug analysis.