chimera biotec GmbH

Ultra sensitive PK bioanalytical sample testing | Pharmacokinetic Assays

PK assay study support by Chimera 

Chimera biotec provides ultra sensitive bioanalytical support for modern biotherapeutics (e.g. therapeutic antibodies and proteins) throughout all phases of drug development. Our immunoassay validation is compliant with GLP/GCP regulations and follows international regulatory standards (EMA, FDA, ICH) to ensure that your bioanalytical method is qualified, fully validated, and documented.

Chimera’s large molecule pharmacokinetic testing services include:

• Exploratory, preclinical and clinical support (PK / PD / ADME)
• Full assay development
• Assay transfer
• Assay optimization (Sensitivity / Specificity)
• Sample testing support (exploratory, GLP, GCP, GCLP)

Applications Services

Biomarker

Our high-precision biomarker assays offer you reliable and fast results that make a decisive contribution to optimizing your research and clinical studies. Rely on our expertise and state-of-the-art technology to take your projects to the next level.

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.

Benefit from more than 20 years of experience in PK assay development

• Sensitivity meets assay range: One of Chimera’s expertise is ultra sensitive PK study support. Combining broad quantitative range with excellent sensitivities, we offer unmatched biologics PK support using a single assay format. From high dosing in TOX through extreme low dosing in dose escalation in the later clinical stage, chimera biotec provides regulated PK sample testing using validated methods, based on the same assay format adapted to the intended range of application. This eliminates the need to run several assays to pair sensitivity and dynamic assay range.

• PK Profile: Chimera’s capability to measure low concentrations of a given drug, we are able to provide a complete PK profile even for initial doses and thus shorten Phase I trials. Our high-quality data meet your regulatory requirements and can be decisive to evaluate ongoing dose escalation.

Ask a PK PD Assay Development Specialist contact@chimera-biotec.com

PK PA assay testing in rare matrices

Chimera’s long-running experience in diverse and rare matrices helps to understand the pharmacokinetic profile of your drug compound in virtually any matrix:

• Serum/ plasma 
• Cerebrospinal fluid (CSF)
• Cell culture medium
• Bronchoalveolar lavage fluid (BALF)
• Tissue extracts and lysates
• Mouse tail vein
• Tears
• Saliva
• Synovial fluid
• And many more

PK PD assay services Case studies

LBA Bioanalytical PK support for Biologics: The Need for Sensitivity combined with broad assay Range:

Request the poster including three case studies, that show ultra sensitive therapeutic antibody quantification in biological matrix.

ADAs might bind to therapeutic proteins and affect their efficiency and clearance. They could also cross-react to endogenous proteins and induce downstream effects that range from mild side effects, allergic reactions, altered pharmacokinetics up to severe effects on patient health.