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Chimera Biotec

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Dortmund, DE

About Chimera Biotec

Founded: 2000 Type: Privately Held Size: 11-50 employees

Chimera Biotec is a bioanalytical CRO specialized in ultra sensitive and technically demanding immunoassays.
We provide GLP/GCP bioanalytical support for all phases of drug discovery and development - from antibody qualification, assay development, method validation to bioanalysis.
We provide solutions for the quantification of large molecule targets in virtually any biological matrix, all on your preferred in-house platform, on your matrix and under the strict quality regime of your choice.

Our award-winning Immuno-PCR platform Imperacer® combines sensitivity (detecting in sub pg/ml) and broad assay range (3-6 log units), as well as performing multiple immunoassays in parallel requiring minimal sample volume. Standard platforms like Simoa®, MSD™ and highly sensitive ELISA are available as well.
 
Our team of dedicated scientists is committed to deliver immunoassay performances, which exceede your highest expectations.

Our Services (20)


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IND-Enabling Studies

Price on request
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Ultra-Sensitive Simoa Assays

Price on request

The Simoa Analyzer combines single molecule analysis with digital ELISA readout. Analytes are captured in solution by antibody loaded beads instead of target-antibody interaction on an antibody immobilized solid surface. Beads -loaded with target or not- are trapped in femtoliter sized microcavities and return digital signal (on/off) for analysis.


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Biomarker Assay Development

Price on request

Chimera Biotec is highly experienced at providing ultra sensitive biomarker sample testing for all phases of drug development - from discovery to preclinical and clinical studies. We have a long track record of supporting trials targetting a wide range of disease areas including oncology and neurology (CNS), as well as inflammatory, infectious and metabolic diseases. Virtually any matrix can be explored.


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Bioanalytical Assays

Price on request

Chimera Biotec is well aware of the critical role ultra sensitive bioanalysis plays in modern drug development of biologics, biosimilars and biobetters. It is our goal to ensure your success in all phases of drug development providing highly sensitive, accurate and reliable bioanalysis data on-time.

Your study samples will be stored, handled, analyzed, reported and archived with greatest care and swift turn around:

  • Ultra sensitive ligand-binding assay sample testing e.g. based on Chimera Biotec’s proprietary Imperacer® platform
  • Sample storage in monitored environment
  • Spirit of GLP or method transfer for bioanalytical sample testing support under full GLP regime according to validated SOPs
  • Sample logistics and data reconciliation services to support multi center clinical trials


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Immunoassay Development

Price on request

Consult Chimera Biotec´s technology evaluation services for customized immunoassay solutions.
At Chimera, we have the scientific experience and technical capabilities to define the optimal platform technology based on your pharmacological requirements. Study specific requirements may lead to bioanalytical challenges beyond the capanilities of standard large molecule sample testing. We will find and work on the perfect solution together with you.

Our highly experienced project management and scientific team will ensure that your needs for ultra sensitive immunoassay sample testing support and regulatory guidance will make the perfect match.

Aiming for non-regulated discovery phase support, spirit-of-GLP clinical phase support or IND-enabling TOX under full GLP-regime, we will make sure that the bioanalytical method validation is custom designed towards your expectations on bioanalytical support.


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Assay Development

Price on request

Chimera Biotec is the worlds leading provider of Immuno-PCR (IPCR) based assay development services for novel biologics and biosimilars and biomarkers; basically any kind of macromolecule analyte. Further technologies like Simoa, MSD and ELISA can be offered.

Immunoassay development at Chimera Biotec begins with in-depth consultation with your dedicated project manager, to develop the optimal workplan for your project:

  1. Reagent Qualification: Provide us your proprietary critical reagents or support our search of suitable commercial material with your guidance
  • Antibody-DNA conjugation (if required): We make sure that the coupling of marker DNA to the detection reagent supports it´s functionality and binding epitopes
  • Assay setup and optimization: We aim for highest sensitivity, suitable sample consumption and adaptation to your intended study matrix. Direct communication between you and our dedicated project managers will support us to develop the method according to your expectations.
  • Assay parameter characterization and pre-validation: Fine-tune the method for upcoming studies in preclinics and clinics. Our dedicated project managers develp a validation protocol together with you according to your study requirements and regulatory guidelines.


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Biomarkers

Price on request

Make use of our bioanalytical sample testing support and have a look at our Biomarker Menue:
http://www.chimera-biotec.com/applications/biomarker-menu/


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Pharmacology & Toxicology

Price on request

Combining broad quantitative range with excellent sensitivities, Chimera Biotec is able to support biologics PK using single assay formats. From high dosing TOX through extreme low dosing in dose-escalation to later clinical stage, we provide regulated PK sample testing using validated methods, based on the same assay.
Eliminate the need to run several assays to pair sensitivity and range.


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Bioanalysis

Price on request

Chimera Biotec offers state-of-the-art bioanalysis for the development of safe and effective biotherapeutics.
At Chimera, your study samples will be stored, handeled, analyzed, reported and archived with greatest care and swift turn around.
We offer ultra sensitive ligand-binding assay sample testing, exploratory sample testing or GLP/GCP regulated bioanalytical support. We support sample logistics and data reconciliation services in multi-center clinical trials and offer sample storage in a 24-7 monitored environment.


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Project Management

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Pharmacology

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Pharmacology Services


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Drug Discovery & Development

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Drug Discovery & Development Services


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Biomarker Analysis

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ELISA

Enzyme-linked immunosorbent assay
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Protein Quantification

Price on request

Protein Quantification Services


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Protein Purification

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Protein Purification and Quantification Services


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Protein Services

Price on request

Protein Services


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Biochemistry & Molecular Biology

Price on request

Biochemistry & Molecular Biology Services


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Biology

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Biology Services


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Immunoassays

Price on request

Immunoassays Services


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Mark Spengler

Director Project Management

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