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.
Advanced Production Platform: Viralgen uses its Pro10™ technology, based on HEK293 cells, for high-purity AAV manufacturing.
Impact of Digitalization:
Optimization of efficiency and quality through tools such as SAP (ERP) and LIMS (Laboratory Information Management System).
Real-time monitoring of key parameters in bioreactors.
Implementation of an Electronic Lab Notebook (ELN) in the development phase.
Security and Traceability:
Use of CRM, DMS, and QMS systems for quality and customer relationship management.
Implementation of cybersecurity measures with an Information Security Management System (ISMS), progressing toward ISO 27001 certification.
The Value of Data:
Development of interactive dashboards for analysis and decision-making.
Use of mathematical models and digital twins to predict product manufacturability.
Creation of a Customer Portal to enhance client experience by providing access to key project information.
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.