Introducing Laboratory Automation into a Regulated Environment: From Proof-Of-Principle to High-End Solutions

Clinical chemistry and centralized laboratories introduced automation decades ago to drive efficiency and lower costs. In contrast, contract laboratories have been reluctant to introduce robotics, mostly due to the unique aspects of the work. CRO laboratories must manage complex, evolving needs such as method adjustment and small batch runs, which make programming automation more challenging.

Until recently, the required financial investment made lab automation more futuristic than realistic. Now, however, increasing throughput, traceability and reproducibility demands create a case for automation in GxP-regulated laboratories.

This webinar shares the advantages and challenges experienced firsthand while transforming Celerion’s laboratories into a highly automated facility. The content includes the unique approach required by a CRO vs biopharma based labs in regards to user requirements and system validation. Highlights will include the application of the “paperless” laboratory via electronic laboratory notebooks (ELN) and laboratory information management systems (LIMS). The intersection of the ELN, LIMS and the laboratory equipment automation is presented via data flow illustrations that span method testing and release, the methodology of error reporting and scheduling. Equipment automation highlights include the integration of robotic systems for advanced applications, such as fully automated solid-phase extraction and a robot dedicated to the preparation of calibrators and quality control samples.

Speakers

Dr. Michael Gröschl, Associate Director, Bioanalytical Laboratory, Celerion Switzerland

Dr. Michael Gröschl joined Celerion in 2012 to support laboratory operations under GxP, with special consideration of laboratory automation. Prior to joining Celerion, Gröschl was a Laboratory Manager of the Laboratory for Vaccine Research & Development, Hospital for Children and Adolescents, at Friedrich-Alexander-University in Erlangen, Germany. Gröschl holds a PhD in pediatric endocrinology from the University of Erlangen-Nuremberg. He has been published in more than 60 scientific publications on various topics in bio-analytics.

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Rebeca Schibli, Team Leader, Automation and ELN, Celerion Switzerland

Rebeca Schibli leads the automation and ELN team and is responsible for developing and implementing solutions to automate Celerion’s diverse bioanalytical assays. Schibli joined Celerion in 2010 utilizing her skills in extrapolating and combining information from different sources which led to an increase in user acceptance and active use of Celerion’s electronic laboratory notebook. Further education and greater experience in various robotic systems allowed her to take an active role in the development and implementation of automated processes. Schibli holds a master’s degree in sciences from the University of Zürich and is skilled in building and implementing efficient and simplified processes.

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