Challenges Faced by the End Users During the Qualification of Single Use System


14th January 2019 | 15:45 PM CET/ 9:45 AM EST | Ben Jeyaretnam (Ph. D., MBA), E&L Analytics Lead of Sanofi at Swiftwater and Dr Andreas Nixdorf, Team Manager / Business Development Manager R&D at SGS Group |BOOK FREE SEAT

The pharmaceutical industry has been increasingly using single-use systems (SUS) for bioprocessing and storage of intermediate and final bulk material in addition to primary packaging.  Before a SUS could be used in the manufacturing process, it needs to be qualified for use by a pre-determined process.  This presentation will discuss a variety of challenges, both internal and external to the industry that the end user faces during the qualification process.  The complexity of SUS, varying quality of vendor data, component change management, changing regulatory expectations, analytical data generation, logistical challenges during E&L study execution, analytical challenges, and the potential impact of unexpected E&L study results will be presented.

Presented by Ben Jeyaretnam (Ph. D., MBA), E&L Analytics Lead of Sanofi at Swiftwater

Ben Jeyaretnam (Ph. D., MBA) leads E&L analytics and a group of scientists involved in qualifying Single Use System (SUS) at Sanofi, Swiftwater, PA for the last four years.  My group manages the studies internally and at external laboratories to generate analytical data needed to qualify the use of SUS in the production.  Ben Jeyaretnam has spent 15+ years with Sanofi Pasteur in various roles:  Analytical team manager, Analytical lead on new vaccine projects, Assay transfer coordinator and developed and validated analytical methods.  He was also a reviewer and approver of CMC section of BLA and familiar with CTD format and is Knowledgeable in cGMP and GLP requirements.

 

Sponsored by SGS Life Sciences

SGS Life Sciences is a leading contract service organization providing analytical development, biologics characterization, biosafety and quality control testing. Operating a wholly-owned network of 18 laboratories in 11 countries, SGS delivers complete lifecycle solutions for pharmaceutical, biologics, and medical device manufacturers.  Our services include: analytical chemistry, microbiology, stability studies, bioanalysis, extractables/leachables, virology and protein analysis.

SGS is experienced in testing extractables and leachables from primary and secondary packaging for pharmaceuticals, process equipment including single use systems, and components parts from medical devices. SGS designs and performs extractable and leachable studies that will satisfy regulatory authorities such as the FDA and EMA as well as adhere to ASTM, ISPE, PQRI, BPOG, BPSA, and PDA recommendations.

 

Presented by Dr Andreas Nixdorf, Team Manager / Business Development Manager R&D at SGS Group

Dr. Nixdorf has been with the SGS Group in Germany since 2007, and is currently senior project manager in the Life Sciences division, with a primary focus in Extractable and Leachable projects. Dr. Nixdorf has a strong background in quality control testing of finished drug products and analytical method development and validation, residue analysis of different biological and polymer materials; and has been dealing with analytical challenges and questions for over 20 years. With a PhD in organic chemistry, majoring in mass spectrometry, Dr. Nixdorf worked for various contract laboratories and was head of a laboratory for about 8 years.

 

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