NUVISAN Pharma Services

Transcription

1 NUVISAN Pharma Services CESI MS Now available! 1st CRO in Europe! At the highest levels of quality. LABORATORY SERVICES Equipment update

2 STATE OF THE ART AT NUVISAN CESI MS Now available! 1st CRO in Europe! In order to keep up with the latest developments in the field of cgmp regulated biopharmaceutical analytics, NUVISAN has added several Mass Spectrometry (MS) techniques to its repertoire. We will be the first CRO in Europe to provide the coupled method of CESI-MS (Capillary Electrophoresis + Electrospray Ionization + Mass Spectrometry) which will enable us to identify and analyze proteines in a way that all existing approaches could not provide for State-of-the-art and complementary platforms for GMP-testing of Chemical Entities and Biopharmaceuticals A team of experts dedicated to your projects High flexibility High throughput capabilities Staff turn over less than 2% Center of excellence for GMP testing of Biopharmaceuticals Biopharmaceuticals. Director Pharmaceutical Analytics Phone: Fax: [email protected] Senior Manager Business Development Mobile: Fax: [email protected]

3 GMP C T O M P L I A N Capillary Electrophoresis (CE) is an ideal separation technique for highly charged and polar molecules, which can be challenging for liquid (LC) or gas chromatography (GC). In addition, CE offers advantages of minimal sample volumes (nl pl), high separation efficiency, and fast injection-to-injection times. As an automated system it provides reproducible and quantitative results, time after time. Quality control of therapeutical proteins Molecular weight estimation pi determination and charge heterogeneity Carbohydrate analysis of glycoproteins Formula weight and counter ion replacement analysis Single enantiomer drug purity assays Advanced capillary isoelectric focusing (cief) PA 800 plus Pharmaceutical Analysis System Ultra performance liquid chromatography (UPLC) in combination with high resolution mass spectrometry is a traditionally founded and well established analysis methodology for the qualification, quantification and identification of diverse compounds. Quantitative peptide mapping Analysis of intact and reduced therapeutic monoclonal antibodies (mab) Simultaneous quantitative and qualitative analysis of proteolytic digests of therapeutic monoclonal antibodies Quaternary UPLCs in combination with the AB SCIEX Q-TOF 5600 mass spectrometer allows high speed, maximum sensitivity and high resolution power to deliver comprehensive qualitative exploration, rapid profiling and quantitation in a single run. SWATH Acquisition provides comprehensive quantitative MS/MS data on every component in one sample. 5

4 CESI MASS SPECTROMETRY CESI MS Now available! 1st CRO in Europe! 3 6 Capillary electrophoresis with an integrated electrospray ionization source (CESI) combines high efficiency and ultra-low flow (5 30 nl/min) with reduced ion suppression. Coupled with high resolution mass spectrometery (HRMS) results in greatly improved sensitivity. Intact antibody characterization Peptide mapping CESI 8000 High performance separation-esi module in combination with the AB SCIEX Q-TOF 5600 Systems

5 56 Enzyme immunoassay (EIA)/enzyme-linked immunosorbent assay (ELISA) is a fully automated antibody based detection assay with an enzyme as the reporter label for routine validation of multitudes of compounds. Quantitation of residual protein A Quantitation of residual CHO host cell proteins Tecan Freedom EVO 200 and Infinite 200 PRO NanoQuant

6 Our resources become yours. Fully integrated Contract Research Organisation with over 30 years of serving the pharmaceutical industry. ADDRESS Im Wirrigen Waltrop, Germany Phone: Fax: CONTACT Director Pharmaceutical Analytics Phone: Fax: [email protected]