Applications Biomarker testing services assays

Biomarker testing services

Chimera is highly experienced at providing ultra sensitive biomarker sample testing for all phases of drug development – from discovery to preclinical and clinical studies. Benefit from Chimera‘s >20 years of in-depth experience as the specialty CRO for immunoassays which go beyond the scope of what is usually considered feasible.

Understanding the critical role of ultra-sensitive bioanalysis in the development of novel therapeutics, Chimera is committed to providing support for all phases of the drug development process.

Make use of our services in:

  • Exploratory/ Pre-clinical studies: Biomarker, PK, immunogenicity, microsampling
  • Phase I-IV studies: Biomarker, PK, immunogenicity, microsampling, multi-center trial support
  • One assay throughout all phases of drug development; From pre-clinics to phase IV
Ask our Scientist Team

From TOX to clinic

We have a long track record of supporting trials targeting a wide range of disease areas including oncology and neurology (CNS), as well as inflammatory, infectious, metabolic and rare diseases.

We also have long-running experience in diverse and rare matrices, e.g., serum/plasma, CSF, cell culture/medium, tissue extracts, mouse tail vein, tears, saliva, synovial fluid, and many more. Virtually any matrix can be explored utilizing the Immuno-PCR platform Imperacer® with outstanding ability to maintain supreme sensitivity despite high sample dilution and testing multiple targets in parallel.

Check for bioanalytical support

Team Biomarker

Contact

Team Assay

Contact

Team Science

Contact

Application services

csm_Icon_ADA Immunogenicity testing services NAb assays

ADA/immunogenicity

Our ADA/immunogenicity assays provide you with reliable and sensitive analyses that are crucial for evaluating the safety and efficacy of your biological therapies. Rely on our expertise and state-of-the-art methodology to comprehensively assess the immunogenicity risk of your products.

csm_Icon_Pharmacodynamic GLP GCP EMA FDA ICH PK PD ADME

PK/PD

Our PK/PD assays provide you with precise and meaningful data that is essential for the successful development and approval of new therapies. Take advantage of our advanced technology and expertise to drive your drug development forward.

Applications icon ADA Nab PK PD Assay testing service

Applications

Back to overview of all applications we offer: PK/PD, ADA/ NAb(immunogenicity), biomarker

Literatur ADA and NAb Immunogenicity PK bioanalytical Pharmacokinetic Assays

Literature

Our comprehensive literature search and evaluation provides you with sound and up-to-date scientific findings to support your research and decision-making processes.

MSD immuno Assay development 96 Well
PK PD Assay hell Ultra sensitive PK bioanalytical sample testing Pharmacokinetic Assays

PK/PD Pharmacokinetics

More

Biomarker_list_hell Biomarker, PK, Immunogenicity, Microsampling Phase I-IV: Biomarker, PK, Immunogenicity, Microsampling, Multi-Center Trial Support

Biomarker
list

More

Literatur_icon_hell Literature Paper, Poster, Publications

Literature
download

More

GLP/GCP-compliant biomarker analyses

We meet the highest quality standards for regulatory studies

The highest quality standards are essential in the pharmaceutical industry. Especially in clinical studies, all data and results must be subject to strict regulations. Chimera is aware of this responsibility and therefore offers GLP/GCP-compliant biomarker analyses.

What do GLP and GCP mean? GLP stands for “Good Laboratory Practice” and describes the guidelines for conducting pre-clinical safety tests. GCP, on the other hand, stands for “Good Clinical Practice” and describes the conduct of clinical trials with humans. Both guidelines guarantee the quality, integrity and reproducibility of data.

Why are GLP/GCP-compliant biomarker analyses so important?
By adhering to GLP/GCP guidelines, we can ensure that our biomarker data are:

  • Reliable and based on validated methods.
  • Reproducible so that results can be confirmed in other laboratories.
  • Transparently documented to ensure traceability. We comply with regulatory requirements so that studies are approved, and results are recognized.
Contact to GLP/GCP Team

ADA testing service Assay NAb Monitor
ADA Testing service Assay NAb clinical

chimera biotec GmbH as your partner for GLP/GCP-compliant biomarker analyses.

Touch points

We have extensive experience in conducting GLP/GCP-compliant studies and offer you:

  • Qualified staff: Our employees are highly qualified and experienced in carrying out biomarker analyses.
  • State-of-the-art infrastructure: We work with the newest equipment and technologies.
  • Comprehensive quality management systems: Our processes are certified according to the latest quality standards.

By offering GLP/GCP-compliant biomarker analyses, we help to ensure that your drug development runs quickly and successfully.

 

Chimera Dortmund Chimera Bremen

State-of-the-art technologies

We use state-of-the-art technologies such as Imperacer®, Quanterix’ Simoa® and MSD™. These enable us to detect even the lowest biomarker concentrations with high sensitivity. This gives you precise and fast results, resulting ina competitive advantage for you. Benefit from our expertise and the latest developments in biomarker analysis!

Request documents

Applications biomarker assay testing service sensitive also ultrasensitive

Join the biotech revolution – get informed today!

Be part of the change in biotechnology.