Category: Advances in Bioanalytics and Biomarkers
We would like to share how we’ve transformed the workflow in the AbbVie regulated large molecule bioanalysis department from an almost hundred percent manual workflow to a completely automated process. All steps from sample receiving and storage over sample dilution and analysis have been automated and made scalable with the increasing number of biologics in the pipeline. A trend that most pharmaceutical companies have experienced over the last couple of years. For the implementation of the new process several automation vendors were evaluated, new labware had to be introduced at the clinical sites Central laboratories had to learn how to work with 2D barcodes to make full use of automated sample handling systems. The complete organization in the department was operationalized to support the higher throughput. As routine bioanalysis is heavily regulated close interactions were required with QA and the external vendors to implement a compliant workflow that would not be slowed down by e.g. overwhelming documentation practices. Since the introduction of the new processes in 2014, only one year after the new processes were first discussed, several new pieces of equipment were added, the workflow was improved continuously and the throughput increased dramatically. Without increasing the headcount, the number of samples analyzed per year went from 75,000 in 2013 to roughly 130,000 by the end of 2017. To the best of our knowledge the setup in our laboratories is a first-of-its-kind and has not been implemented by other companies. Using our experience and the many lessons learned along the way with some expected and other not so expected pitfalls we want to help others getting the most out of laboratory automation and making it an easier way from the classical wet lab to a modern laboratory. After all, using state of the art automation should help increasing throughput, improving the quality but most importantly also freeing up time to design better experiments and next generation solutions.
Mario Richter– Prinicipal Scientist DMPK-BA, AbbVie Inc., Ludwigshafen, Rheinland-Pfalz, Germany
Prinicipal Scientist DMPK-BA
Ludwigshafen, Rheinland-Pfalz, Germany
Mario studied biochemistry at the university of Frankfurt completing his master thesis on tumor suppressors. He moved on to the institute of molecular pathology (IMP) in Vienna to do his PhD in epigenetics working on the discovery of novel chromatin modifying enzymes. In 2009 he joined a small biotech company (t2cure) working on adult progenitor cells for the treatment of patients after an acute myocardial infarct. In 2010 he moved on to Abbott, now AbbVie, to set up a biochemistry lab in the large molecule bioanalysis department supplying reagents to the assay labs. He saw the need to introduce lab automation to the department to run the routine analysis more efficiently and become scalable with the increasing number of biologics in the pipeline. Since 2012 he helped to transform the standard wet lab processes to fully automated processes encompassing the complete workflow from sample receipt, to storage, dilution and analysis.