Here, process mining technologies provide valuable support, for example by collecting and analysing existing business processes using the available log data. In this context, compliance and IT managers should use two approaches in particular: Firstly, an indicator-based business performance management system that helps decision-makers to identify critical developments in the company at an early stage and to take appropriate countermeasures. All of these areas strictly focus on processes and their continuous improvement. This includes various areas (see figure 1) that need to be analysed and evaluated. RPA in particular proved to be an effective digital assistant that was able to take over some of the workflows completely and also increase process quality - for example, by using a corresponding RPA tool to automatically enter feedback from the authorities into the document and workflow systems.Ĭompanies in the life science sector are familiar with the general challenge this example is based on: How can business processes be transformed so that the trade-offs between several challenges are successfully addressed? For example, when it comes to generating competitive advantages such as reducing the “time to market” of products or services while at the same time maintaining global regulatory compliance?īusiness process excellence as a success factorīusiness Process Excellence (BPE) provides adequate answers and solutions. In order to shorten the workflow associated with this process, as well as the associated data processing, one can evaluate the potential benefits of new technologies such as Process Mining, Robotic Process Automation (RPA) and Text Mining. The modified LVs characterized here have an overall lower risk for insertional mutagenesis than regular LVs and can thus improve the safety of gene and cellular therapy.Back to newsroom Achieving Business Process Excellenceīest practice: Using process mining and RPA in a regulated environmentĪ key metric from the Regulatory Affairs department illustrates the enormous effort involved when coordinating between pharmaceutical companies and regulatory bodies: Approximately every fifteen minutes, the Regulatory Affairs department submits a document for review to authorities such as the FDA or EMA somewhere in the world. Targeting of this highly repetitive region for integration was not associated with detectable DNA deletions or negative impacts on cell health in transduced primary human T cells. In addition to the primary sequence recognized by the endonuclease, integration was also enriched in chromatin domains topologically associated with nucleoli, which contain the targeted ribosome RNA genes. LVs carrying modified I-PpoI-derived homing endonuclease proteins were characterized in detail, and we found that at least 21% of all integration sites localized to ribosomal DNA when LV transduction was coupled to target DNA cleavage. We modified the integration machinery of LVs and harnessed the cellular DNA double-strand break repair machinery to integrate transgenes into ribosomal DNA, a promising genomic safe-harbor site for transgenes. Lentivirus vectors (LVs) are efficient tools for gene transfer, but the non-specific nature of transgene integration by the viral integration machinery carries an inherent risk for genotoxicity.
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