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Celonic launches stand-alone GMP analytics portfolio

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GLP/GCP Analytics

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. Due to several years of experience in analytics for (pre-) clinical studies as well as cell line development and protein production for biopharmaceutical development Celonic has developed to a reliable and competent partner for cell based and protein specific analytics.

Our Juelich Facility is certified for Good Laboratory Practice (GLP) in the category 8 "analytical and clinical chemistry testing" as well as for GMP analytics as a pharmaceutical laboratory. In addition we are trained to measure clinical samples according to ICH-GCP. Of course we are open to handle the complete logistics during preclinical studies or clinical trials for our customers as well.

Celonic provides GLP and GMP compliant development, validation, release and study packages tailored specifically to the individual needs of our pharmaceutical and biotechnology clients.

Our assays:

  • Drug detection in serum, blood plasma etc. (pharmacokinetics)
  • Detection/quantification of anti-drug antibodies (immunogenicity)
    • ADA-Screening/Confirmation
    • ADA characterisation (IgG, IgM etc.)
    • Neutralising antibody
    • Antibody titre determination
  • Biomarker analytic (pharmacodynamic) single/multiplex
    • Cytokine/Chemokine (e.g. Pro-Inflammatory, TH1/TH2, MMP)
    • Heart marker (e.g. Troponin T, CKMB)
    • Bone marker (e.g. Osteocalcin, Osteonectin)
    • Cell signalling pathways (e.g. MAP Kinase, Apoptosis, Insulin Signalling)
    • Metabolic factors (e.g. GLP1, Insulin, Glucagon)
    • Toxicological factors (e.g. Liver Injury, Muscle Injury, Cardiac Injury, Kidney Injury)
    • Vascular and growth factors (e.g. VEGF, Cadherin, sVCAM-1)
    • Fertility marker (e.g. LH, FSH, Progesterone)
    • Alzheimer (e.g. Tau, sAPPalpha)
  • Cell-based assays (ADCC, CDC, proliferation, apoptosis etc.)
    • ADCC
    • CDC
    • Activity / Potency (Apoptosis, Proliferation etc.)
    • Reportergene assay
  • Analysis of bioprocess contaminations
    • Host cell protein (HCP)
    • Protein-A
    • Methotrexate (MTX)
Our methods:
  • Immunological assays
  • Cell based assays (detection by spectroscopy and fluorescence spectroscopy)
  • Reportergene assay (detection by luminiscence)
  • Cell separation (PBMC, NK cells, monocytes etc.)
  • additional analytical methods (on enquiry)
Our services:
  • Method and test development
  • Method and test validation according to ICH
  • GLP/GCP conform study analytics (protein and antibody specific analysis embedded into (pre-)clinical studies)
  • Sample-Kit-Design and sample logistics for (pre-)clinical studies

Beside 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 GLP (GCP) or GMP analytics. Celonic is both performing stand-alone studies and is also acting as a contractual partner in multi-site-studies.

Check with us! We will find a solution for you.

ELISA, highly sensitive ELISA, ECL-ELISA, Electrochemiluminiscence-ELISA, optimized ELISA, cell based asssays, potency assays, ADCC, CDC, proliferation assay, apoptosis assay, specific Host Cell Protein assay, HCP, generic assays, GMP, cGMP, GLP, GCP, GLP certificate, GLP certification, Quality Management, cytokine multiplex assay, cell signalling pathway multiplex assay, validation, development, routine testing, pre-clinical, clinical studies, sample-kit-design, protein based analytics, ICH conform, determination of active ingredient, API, anti-drug antibodies, BCA, cytotoxicity, analytic savings, cell signalling analytics, ECL measuring, signal blockage, buffer, sensitivity, anionic cationic chromatography, HPLC, IEX, IE-HPLC, SEC-HPLC, HP-SEC, residual Protein A analysis, sub-typisation, cell characterisation, viral DNA, host cell DNA, RNA, analytic certificate, certification, CoA, 96-well, USP, United States Pharmacopoia, EP, Pharm. Eur., European Pharmakopoia, cells