NOVEMBER 2024LIFE SCIENCES REVIEW 19drive quantifiable improvements. Incorporating digital solutions needs to be customizable for the diverse landscape of automation needs. Addressing the manpower and skillset disparities across smaller biotech firms and larger pharmaceutical companies is also needed. As digital capability and usage matures, companies will need expertise in areas that they may not be able to provide in-house. Talent recruiting and retention is a real challenge, and smaller firms can benefit from contract partners and the technical expertise of their suppliers.Prioritizing areas for transformation include manufacturing execution systems (MES) or simpler electronic Batch Records (eBR), operational technology (OT) for analytics and predictive models and Process Analytical Technology (PAT). By implementing real-time monitoring of critical process parameters (CPP) and performance attributes (CQA), to analyse and control manufacturing processes, PAT drives improvement of the quality and consistency of pharmaceutical products while enhancing efficiency and reducing production costs.We see the digital transformation of biomanufacturing for fast, flexible and reliable operations, happening in four areas:In Silico Process Development: leveraging software modelling tools and services for rapid and robust Process Development (PD). The goal should be to accelerate, standardize and de-risk PD as well as ease transfer from emerging biotech companies to CMOs. Ambitious goals shall be set on quality (ppk >>1), speed (PD cycle in months) and cost (reduced by a factor of four). Prescriptive Batch: digitally enhancing consumables and process data to feed advanced process control models and drive predictable outcomes for the drug batch. Cell culture media, resins lots, bags etc. come with eCOA (Certificate of Analysis) and genealogy, in an electronic format. This combined with process information can enable fast, high-confidence release of on-spec products. Ambitious goal shall be to reduce batch loss from 12% in average to low single digits, and release in one day. Effective Equipment (OEE): making equipment "smart" for Overall Equipment Effectiveness (maximum uptime and throughput). Connectivity platforms and MR tools enable for fast equipment set-up, reconfiguration and revalidation as well as predictive maintenance. Ambitious goal shall be to increase asset utilization in biopharma from 70% to >90%. Flexible Plant: the idea here is to drive fast scale out, tech transfer and plant reconfiguration for flexible manufacturing. This can be enabled through automation, workflow execution support (with eSOPs, enabled by MR), operator onboarding (enabled by VR training) and recipe management ("digital tech transfer"). Ambitious goal shall be to reduce product change-over and transfer time/cost by 10.The industry's future success hinges on its openness to digital solutions, fostering collaboration across the value chain to realize the full potential of automation and digital transformation in delivering therapeutics efficiently and cost-effectively. The COVID-19 pandemic prompted a shift towards digital possibilities out of necessity, with companies connecting equipment to networks for remote monitoring
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