GMP Analytics / Quality Control

Recombinant proteins and monoclonal antibodies as Active Pharmaceutical Ingredients demand a very specific knowledge of the analytics and the possible regulatory traps. This knowledge is offered by Celonic with our GMP conform development and validation packages which are tailor made to the demands of our customers from Pharma and Biotech industry. We will be happy to support you regarding selection of suitable analytical methods, the design of the needed assay, the set-up of the process development associated analytics also related to (scientific oriented) regulatory questions as well as qualification and validation of analytical methods for clinical projects in different status / phases.
Our production facility in Basel is certified for GMP analytics in combination with our GMP manufacturing for performing the analytical service offerings. We constandly develop further to broaden our service offerings. 

Our analytical method and assay offering:

• Standard methods according to European Pharmacopoeia (EP) and United States Pharmacopoeia (USP) for API, process intermediates, analytics of liquid Drug Substance as well as aseptically filled biological Drug Product in liquid and lyophilized form (e.g. appearance, pH, osmolality, conductivity, visible and non-visible particles)
• Active ingredient specific methods (content analysis, impurities) with HPLC (SEC, IEX, Protein A, RP and specific affinity), SDS-PAGE, Western Blot, IEF, immuno assays based on ELISA technology a.o.
• Highly specific, cell based activity / potency assays according to the demand of the single proteins or monoclonal antibodies in relation to its pharmacologic activity mechanism and/or according to their clinical relevant activity parameters (e.g. ADCC, CDC, proliferation, apoptosis) as well as a specific HCP assay or glycoanalysis using HPAEC-PAD
• Futher analysis on request

Services:

• Methode and test development
• Methode and test qualification and validiation
• Stability studies for reference standards, Drug Substance and Drug Product

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

All services are offered including necessary quality documentation.

Next to pre-clinical and process development analytics for optimization of product yield and quality in the early development phase, we support our partners also in their clinical development studies, e.g. with development of highly sensitive ELISA for analysis of drug candidates and anti-drug antibodies in human blood, blood plasma and serum. Our facility in Jülich is specialized on this and will serve you with GLP/GCP Service throughout your clinical studies.

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

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