Celonic launches stand-alone GMP analytics portfolio
Challenging positions in upstream processing
Analytical Methods for Quality Control
In parallel to the process development and quality control of the final product we apply a broad spectrum of protein analytical methods (1D-, 2D-PAGE, IEF, Western, BCA, OD280, RP-HPLC (Peptide mapping), HPAEC-PAD (glycoanalytics), HP-SEC, Protein A HPLC, ELISA, cell based assays like apoptosis, proliferation, ADCC, CDC,....). With the help of these methods, we are able to identify biopharmaceuticals and to test their purification, integrity and potency. It is our goal to optimize the process at an early stage regarding product recovery and quality.
Please, read also our offering for GMP Analytics as independent service!
Key words: 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