Expertise | GCP & GLP regulated bioanalysis services

Accurate, precise

and comprehensive

 

GLP PK ADA Assay service support

High-quality scientific and regulatory support

Ultra-sensitive support meets your regulatory requirements

As a service provider, we have developed technical capabilities on several ultra-sensitive platforms, starting with high sensitivity ELISA, over the Simoa® technology from Quanterix, MSD™ (Mesoscale Discovery) as well as our own Immuno-PCR (IPCR) platform technology, Imperacer®. We deliver immunoassays to fulfill even your most challenging study requirements.

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Premium immunoassay services tailored to your regulatory needs

GLP-certified laboratories offering GLP, GCP, and non-GxP services with FDA and EMA compliance

Our laboratories and our are GLP and GCPcertified and offers immunoassay services under the regulation of your choice:

♦ GLP
♦ GCP
♦ Non-GxP/exploratory

with compliance to FDA and EMA.

GLP GCP Lab services
Expertise

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MSD immuno Assay development 96 Well

From internal decision making to GLP/GCP regulated studies

We make sure to deliver immunoassay sensitivity under the regulatory regime you need

The development of biotherapeutic drugs is a complex process which presents many challenges that may change over the curse of the study. Assay specific requirements which may change over the different phases of a compound’s pharmaceutical developmentare, e.g.,

♦ Requirements for sensitivity
♦ Sample volume availability
♦ Overall assay performance
♦ Quantification range

Relying on our cumulative expert knowledge and laboratory capabilities, we first validate the assays based on the current regulations and later deliver top-quality bioanalysis on time.

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a-photo-of-a-laboratory-GLP GCP Setting

At chimera biotec, we understand that each study is unique and requires a tailored approach. Our team of experts is dedicated to providing personalized solutions that meet your specific needs. We offer:

  • Customized assay development: Tailoring assays to fit the unique requirements of your study.
  • Advanced technology: Utilizing state-of-the-art equipment to ensure the highest level of accuracy and reliability.
  • Regulatory epertise: Navigating complex regulatory landscapes to ensure compliance and smooth progression through each phase of development.

Collaborative partnership: Working closely with you to understand your goals and challenges, ensuring that we deliver results that exceed your expectations.

Locations of the laboratories

Location advantages

Bremen

Our laboratory location in Bremen offers ideal logistical conditions for efficient sample delivery. Thanks to the excellent transport connections, your samples will reach us quickly and reliably. We use our strategically located site to map our fast and smooth logistics processes.

Dortmund

Our laboratory location in Dortmund benefits from the dynamic innovative power of the city, which is known as an important center for technology and research. Together with our laboratory in Bremen, we offer you a high level of redundancy and additional security for your projects thanks to two locations. Take advantage of our first-class infrastructure and secure reliable and continuous support for your biotechnological requirements!

 

Chimera Dortmund Chimera Bremen
Bioanalyse GLP GCP service support your study

Bioanalysis

Comprehensive bioanalytical services with precision andcare

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
♦ GLP / GCP regulated bioanalytical support or exploratory sample testing
♦ Sample logistics and data reconciliation services supporting multi-center clinical trials
♦ Sample storage in 24/7 monitored environment

Advanced bioanalytical solutions for your research needs

Partner with us to leverage our expertise and cutting-edge technology for your bioanalytical needs. Our state-of-the-art ligand-binding assays ensure the highest sensitivity and specificity, providing you with reliable and accurate results for your critical research. Whether you need regulated bioanalytical support for clinical trials or exploratory testing for early-stage research, our team adheres to GLP and GCP standards to guarantee compliance and quality. We offer comprehensive logistics and data reconciliation services, ensuring seamless coordination and integrity of your samples across multiple trial sites. Your samples are stored in our secure, continuously monitored facilities, always ensuring their stability and integrity.

We are committed to delivering precise, timely, and high-quality results to support your scientific endeavors.

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Lab GLP GCP Bremen

Comprehensive bioanalytical support

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Bioanalytical support for biotherapeutics throughout all phases of drug development

From high to extreme low dosing, we provide regulated sample testing using validated methods, based on the same assay. Our immunoassay validation is carried out as described by the Federal Drug Association (FDA) and European Medicines Agency (EMA) guidelines for bioanalytical method validation. We validate your assay for the following study types:

♦ Exploratory
♦ TOX
♦ Dose escalation
♦ Pre-clinical
♦ Clinical

Model GCP GLP regulated study supply

 

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Expertise | Ultra Sensitive Ligand-Binding Assay Capabilities

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