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

Life Sciences, Clinical Trials, Laboratory Technology,
  • Wednesday, November 04, 2020

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

http://Michael%20Groschl,%20Celerion

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.

Message Presenter
http://Rebeca%20Schibli,%20Celerion

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.

Message Presenter

Who Should Attend?

  • Lab managers with the intention to introduce automation
  • Lab automation vendor representatives
  • Clients (outsourcers and scientists), who want to learn about possibilities to conduct upcoming studies using fully automated bioanalytical methods

What You Will Learn

In this webinar, participants will learn:

  • System requirements and validation
  • Routine checks for the systems, connection to the ELN
  • Bioanalytical method development, testing and release using lab automation
  • Celerion lab automation capabilities

Xtalks Partner

Celerion

Celerion, a global leader in early clinical research services offers a unique combination of medical expertise, clinical operations experience and scientific excellence that gives our clients the confidence to make fast, accurate decisions about their drug development path. For fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic and pharmacodynamics studies in highly controlled clinic environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion studies as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. Celerion offers feasibility, data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world. For more information, please visit www.celerion.com. 

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