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“.

Our Experience

Long-lasting experience in the development of diagnostic tests provides in-depth understanding for the transfer, the optimization and validation of your assay.

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.

Non-GLP discovery services
GLP and GCP services for assays in preclinical and clinical phase
Adaption to your regulatory compliance needs

Our portfolio includes

Services
Assay development
Assay transfer
Assay validation (exploratory, research grade or full QA involvement)
Sample measurement
Assays
classical ELISA formats (commercial, transferred or developed)
Cell-based assays
Molecular assays
Technology platforms
Protein Simple ELLA®, automized immunoanalyzer
Roche Diagnostics Cobas® c311, clinical chemistry analyzer
Roche Diagnostics Cobas® e411 and e601, immunology analyzer
Biacore® 2000, surface plasmon resonance
Roche Diagnostics Light Cycler 480, realt-time PCR

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

Services
Assay development
Assay transfer
Assay validation
Biomarker quantification
Consulting regarding regulatory guidelines
Safety Package
Pharmacokinetics
Anti-drug antibodies
Neutralizing ADAs
Sample pretreating
Methods
Screening immunogenicity ELISAs
Confirmatory immunogenicity ELISAs
Quantitative PK ELISAs
Cell-based assays for neutralizing anti-drug antibodies.

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

Services
Assay development
Assay transfer
Assay validation
Testing strategy
Screening assay
Confirmatory assay
Neutralizing antibody assay
Test formats
Bridging ELISA
Sandwich ELISA
in-vitro cell-based assays (NAB)

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.

Samples comprise reference materials, commercial samples and clinical samples.
Sample testing is generally offered as GLP or non-GLP service.
Sample testing can be performed using any ELISA parameter or PCR assay available on the market.

Our portfolio includes

Services
Support in assay choice
Adaption of assay formats
Assay validation
Sample storage
Technology platforms
Protein Simple ELLA®, automated immunoassay analyzer
Roche Diagnostics Cobas® e411 and e601, immunology analyzer
Roche Diagnostics Cobas® c 311, clinical chemistry analyzer
Biacore® 2000, surface plasmon resonance
Roche Diagnostics Light Cycler 480, real-time PCR
Sample types
Human and animal
Blood
Serum
Plasma
Urine

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.

Samples comprise reference materials, commercial samples and clinical samples.
Sample testing is generally offered as GLP or non-GLP service.
Sample testing can be performed using any ELISA parameter or PCR assay available on the market.

Our portfolio includes

Services
Assay development
Assay transfer
Assay validation
Sample measurement
Technology platforms
ELLA®
Cobas® 411
Cobas® 311
Architect®
Biacore® 2000
Light Cycler 480
Expertise
Successful support of biosimilar studies
GLP and GC(L)P studies

Did you know?

Sample management services

We offer sample aliquoting and temperature controlled long-term storage of your samples

Sample management services

We offer sample aliquoting and temperature controlled long-term storage of your samples

Critical reagent supply

Microcoat offers modification and optimized conjugation of antibodies and antigens for your individual assay

Critical reagent supply

Microcoat offers modification and optimized conjugation of antibodies and antigens for your individual assay

Lab-kit production

We built your assay into complete kits for on-site testing in your clinical study

Lab-kit production

We built your assay into complete kits for on-site testing in your clinical study