PK PD Pharmacokinetic bioanalytical immunogenicity ADA testing service.
20 years of experience. GLP/GCP & non GXP.
Anti-drug antibodies Neutralizing antibodies
We offer the following applications: Pharmacokinetics (PK)/pharmakodynamics (PD), biomarker, ADA/immunogenicity. Whether assay development, assay transfer, method validation or bioanalysis – we master your project challenges for you.
Get Support
Our standard procedure
Immunogenicity testing services
ADA and NAb assays
3-Tiered approach
Use our immunogenicity support
Highest quality for your project
Our laboratory is GLP-certified and offers immunoassay services under the regulation of your choice:
♦ GLP
♦ GCP
♦ non-GxP
in compliance with FDA and EMA guidelines, whitepapers and industry best practices.
GLP/GCP-regulated studies
We make sure to deliver immunoassay sensitivity under the regulatory regime you need. The development of biotherapeutic drugs is a very complex process which presents many challenges that may change over the curse of the study. Regulatory requirements which may change over the different phases of a compound’s pharmaceutical 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 detailed by the Federal Drug Association (FDA) and European Medicines Agency (EMA) guidelines for bioanalytical method validation.
♦ Exploratory
♦ TOX
♦ Dose escalation
♦ Pre-clinical
♦ Clinical
Location advantages
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.
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!
German Sports University Cologne and Chimera support each other’s research on gene-doping and molecular pathways to identify doping. This research field is also supported by the World Anti-Doping-Agency (WADA).
Discover the benefits of our first-class solutions! Press the contact button now to arrange a free meeting with one of our scientists. Take advantage of this unique opportunity to clarify your questions and receive individual advice for your projects. Let our expertise convince you and take your research to the next level!
Call us now
