Ultra sensitive PK bioanalytical sample testing
Benefit from more than 20 years of experience in PK assay development
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20 years of in-depth experience
Depending on your needs, Chimera offers kit-based or customized, highly sensitive assays to detect any biomarker within your sample.
Biomarker List
Extreme drug-tolerance in immunogenicity testing
ADA and NAb assays
We develop your assay tailored to your drug and disease and support your study before, during and after approval, since a routine monitoring can show drug efficiancy reduction after longer time periods.
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Ultra sensitive PK bioanalytical sample testing | Pharmacokinetic Assays
PK assay study support by Chimera
Chimera 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 guidelines as well as whitepapers and industry best patrice) to ensure that your bioanalytical method is qualified, fully validated, and documented.
Contact to PK/PD Specialist
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)
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Benefit from more than 20 years of experience in PK assay development
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Sensitivity meets assay range: One of Chimera’s major expertise is ultra-sensitive PK study support. Combining a broad quantitative range with an excellent sensitivity, we offer unmatched biologics PK support using a single assay format. From high dosing in TOX studies through extremly low dosing in dose escalation in the later clinical stage- Chimera 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 meets your regulatory requirements and can be decisive to evaluate drug distribution and clearance behaviors.
Ask a PK PD Assay Development Specialist
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 testing service – Step by step –
1. Click on the button below and tell our science team what your challenge is.
2. We will arrange a meeting with you under CDA conditions.
3. You will receive an offer from us that meets all your requirements.
We look forward to your challenge.
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Selection of PK studies supported by Chimera:
- Cooperation Between Systemic and Mucosal Antibodies Induced by Virosomal Vaccines Targeting HIV-1 Env: Protection of Indian Rhesus Macaques Against Low-Dose Intravaginal SHIV Challenges.
Access here
- Randomized phase I trials of the safety/tolerability of anti-LINGO-1 monoclonal antibody BIIB033
Access here
- Phase I trial of intravenous aviscumine (rViscumin) in patients with solid tumors: a study of the European Organization for Research and Treatment of Cancer New Drug Development Group
Access here
Unmatched sensitivity in PK PD Assay Service
PK PD assay services: Case studies
LBA bioanalytical PK support for biologics: The need for sensitivity combined with a broad assay range:
Request the poster including three case studies, that show ultra-sensitive therapeutic antibody quantification in biological matrix.
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Questions about our PK PD Assay Services ?
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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!
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Ultra sensitive PK PD bioanalytical sample testing | Pharmacokinetic Assays
Find out how Chimera Biotec can advance your research!
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