Analytics (GxP)

Preclinical and clinical trials of biopharmaceuticals require additional tests beyond the standard chemistry and immunology programs. Many of these analyses involve the development of specialized assays that are not routinely provided by most Central Lab Services.

Celonic provides GLP and GMP compliant development and validation packages tailored specifically to the individual needs of our pharmaceutical and biotechnology clients. We are happy to support you in pharmacokinetics, pharmacodynamics or toxicology.

Our Juelich Facility is certified for Good Laboratory Practice (GLP) in the category 8 "analytical and clinical chemistry testing" as well as for GMP as a pharmaceutical laboratory. We are intensively trained to measure clinical samples according to ICH-GCP. Of course we are open to handle the complete logistics during preclinical or clinical studies for our customers as well. Design of sample kits or strategy of shipment - we are happy to satisfy you of our competences.

Our assays:

• drug detection in serum
• detection/quantification of neutralising or agonistic antibodies
• detection of numerous markers (single-/multiplex)
• cell-based assays (ADCC, CDC, proliferation, apoptosis etc.)

Our methods:

• analytical and immunological assays (ELISA, electrochemiluminescence)
• protein concentration analysis (BCA)
• additional analytical methods (on enquiry)

Next to the methods we have established already, we are open to implement and further develop our customers’ assays quickly and reliably and to validate them for GxP analytics. Celonic is both performing stand-alone studies and is also acting as a contractual partner in multi-site-studies.

Next to preclinical und clinical development, we are ready to support you in other phases of drug development, for example during selection of the most efficient drug candidates. Furthermore, we can be your reliable partner in drug release analytics, testing biological efficacy. Is your lead product an antibody? Then we are able to measure for example antibody dependent cellular cytotoxicity (ADCC) as well as complement dependent cellular cytotoxicity (CDC).