Impurity Analysis and Analytical Testing to be Discussed at CPhI by SGS Experts

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Impurity Analysis and Analytical Testing to be Discussed at CPhI by SGS Experts

SGSSGS, a leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, has announced that Mr Gerald Dallmann, Division Manager, and Dr.Christian Textor, Project Manager Extractables & Leachables, will be hosting showcase lectures at the upcoming CPhI Worldwide Conference and Exhibition, to be held at the Fira de Barcelona Gran Via, Barcelona, Spain, on 4-6 October  2016.

Mr Dallmann’s presentation on Tuesday 4 October at 4.00 PM will take place at the ICSE Showcase Booth 2G70. Entitled “Identification of Surface Impurities and Particles by Means of Special Analysis Methods,” the session will discuss how the analysis of surface contamination, and of particles as foreign material, is important for product release, failure and damage analysis, also for product quality assurance. The presentation will highlight a number of analytical methods and will illustrate the benefits and applications of each in the context of customer case studies.

Dr Textor will also present at the ICSE Showcase Booth on Wednesday 5 October at 1.00 PM on the subject of “Considerations for Extractables and Leachables Testing.” This presentation will demonstrate strategies for the evaluation, identification, quantitation and specification setting of extractables and leachables from single-use materials within pharmaceutical manufacturing.

Practical guidance in study design to satisfy regulatory authorities such as the FDA and EMA will be given, as well as adhering to Product Quality Research Institute (PQRI), BioPhorum Operations Group (BPOG), Bio-Process Systems Alliance (BPSA), and ISO 10993 recommendations.

Mr Dallmann joined the SGS Institut Fresenius GmbH in Dresden, Germany, in 2009, and his primary responsibility is the analysis of materials, surfaces and particles for high-technology sectors such as the semiconductor, pharmaceutical and automotive industries.

Prior to joining SGS, he was Director for Technology Development at Qimonda (part of Siemens/Infineon), responsible for process integration, yield enhancement and technology development of semiconductor products. He holds an Engineer’s degree in Microelectronics Technology and Semiconductor Devices.

Dr Textor joined SGS Institut Fresenius GmbH in 2015, is based at its new facility in Wiesbaden, Germany, and is an expert in planning, running, reporting and the documentation of extractables studies. He previously held the position of Product Manager at Knauer GmbH, and obtained his Diploma and subsequent PhD in Medicinal Chemistry in Regensburg, Germany.

With 21 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms.

In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I-IV clinical trial management, and services encompassing data management and statistics, PK/PD modelling and simulation, pharmacovigilance and regulatory consultancy.