Company Profile

Back- ground

We are a team of internationally recognized experts for biomarker analyses and data interpretation. With a track record of more than 50 industry-sponsored trials and 40,000 samples we aquired an excellent international reputation.

We have many years of experience in the preparation and implementation of biomarker analyses for (pre-)clinical studies, both industry-sponsored and investigator-initiated.

Services

CheckImmune offers consultancy and laboratory services to support clinical development from preclinical studies to clinical trials. The service includes the development, validation and application of immunological biomarkers for de-risking new drug developments and stratification of patient groups.

Further services comprise:

  • drug candidate selection/validation
  • therapy monitoring (safety, efficacy)
  • mode-of-action studies
  • surrogate markers
  • data interpretation (including medical advice)

Innovation:

  • Development of new tests in collaboration with diagnostics industry
  • Pipeline: new tests and technologies like epigenetics analyses, organ(s)-on-chip technology, new functional assays, new tests for liquid and tissues biopsies

Network:

  • Close collaboration with partner clinics to validate the tests on biosamples from targeted patient populations
  • Being embedded in the academic environment of Charité – Universitätsmedizin Berlin (Charité university clinic) allows us access to several state-of-the-art technologies
  • Close collaboration with Charité Research Organisation GmbH (well experienced CRO for complex early clinical trials)

The laboratory has an accreditation according to DIN EN ISO 15189 and DIN EN ISO/IEC 17025, is EMA/FDA compatible and passed several  audits successfully.

structure

To guarantee the high regulatory standards of an accredited laboratory for biosamples analysis whilst keeping the necessary flexibility in the development of new tests and explorative clinical studies, we created two subunits:

The Immunological Study Lab (ISL) is a DAKKS-accredited laboratory that is compatible with EMA/FDA standards. The laboratory carries out immunological tests to analyze patient samples from clinical trials, performs validation studies for immunological test systems, and offers advice on selecting appropriate immunological biomarkers for monitoring clinical trials.

Because of the lab’s close link to the scientific environment of the research groups at both the Institute for Medical Immunology and the BCRT, newly discovered biomarkers can be quickly transferred to validated test systems. Our proximity to and long-standing close collaboration with the Charité Research Organization (CRO) means that delicate blood samples from clinical studies can be evaluated with sensitive pre-analytics, and abnormal, clinically relevant findings can be communicated in a direct and speedy manner. ISL was and still is involved in contract research collaborations with numerous pharmaceutical and biotechnology companies, including, among others, Baxter, Bayer, Novo Nordisk, Boehringer Ingelheim, Sanofi, Novartis, Biogen, Pluristem and Apceth.

The scientists of the Biomarker Development and Exploration Lab (DEL) advice, select and pre-test (in vitro and in vivo) potential biomarker candidates in advance of clinical trials to make them ready for transfer into ISL. We develop new tests and perform feasibility and validity testing in explorative clinical biomarker studies (PoC) and explore new test platforms for the application of biomarker analysis in clinical trials in terms of feasibility and validity. In addition, we analyze and explore any safety concerns that arise in the application of new therapeutics and develops possible solutions (e.g. cytokine release induction, immunotoxicity).

Copyright 2019 by CheckImmune GmbH
Imprint and Data Protection