The article, written by María Iglesias, Digital & IT Head at Viralgen, explores how digitalization has transformed the manufacturing processes of adeno-associated viral (AAV) vectors at the company. Viralgen specializes in producing these viruses for gene therapies, enabling the delivery of genetic material to specific cells.
Key Takeaways from the Article:
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Advanced Production Platform: Viralgen uses its Pro10™ technology, based on HEK293 cells, for high-purity AAV manufacturing.
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Impact of Digitalization:
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Optimization of efficiency and quality through tools such as SAP (ERP) and LIMS (Laboratory Information Management System).
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Real-time monitoring of key parameters in bioreactors.
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Implementation of an Electronic Lab Notebook (ELN) in the development phase.
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Security and Traceability:
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Use of CRM, DMS, and QMS systems for quality and customer relationship management.
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Implementation of cybersecurity measures with an Information Security Management System (ISMS), progressing toward ISO 27001 certification.
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The Value of Data:
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Development of interactive dashboards for analysis and decision-making.
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Use of mathematical models and digital twins to predict product manufacturability.
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Creation of a Customer Portal to enhance client experience by providing access to key project information.
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Viralgen has made digital transformation a strategic pillar, improving its competitiveness and enabling faster, more efficient gene therapy manufacturing. Its focus on data and technology not only optimizes processes but also facilitates patient access to life-changing treatments for rare diseases.
