Computer modeling techniques that accelerated the production of COVID-19 vaccines could benefit the wider vaccine sector if international regulators can develop harmonized guidelines. Bringing a vaccine to market using traditional methods takes a long time. Candidates typically go through years of preclinical testing, followed by extensive safety and efficacy assessment in clinical trials that can take a decade or more.
Even after preclinical testing and clinical development is complete, there is more to do. Scaling up laboratory-based production processes so that they can support commercial supply can take a significant amount of time. Indeed, a new study in Current Opinion in Chemical Engineering suggests that using traditional methods, vaccine process development can account for up to 30% of the time needed to bring a new vaccine to market.
But process development does not need to take so long, according to the authors, who write that, “The three COVID-19 vaccine approvals within a year of the pandemic’s start highlight technology’s accelerating role.” In particular, they point to computer modeling as an approach that could significantly accelerate vaccine process development.
“Model-based approaches offer significant opportunities for enhancing vaccine production. Current advances in modeling biopharmaceutical processes can address the multiscale and multidisciplinary nature of the underlying mechanisms,” they write. “They provide powerful tools that can significantly reduce the cost and time in the development stage and facilitate scaling-up and transfer of bioprocesses to other manufacturing sites.”
Tackling scientific bottlenecks
In addition to the rapid development of COVID-19 vaccines, the authors cite the Inno4Vac project—a public-private partnership that aims to tackle scientific bottlenecks in vaccine development—as illustrative of the potential benefits of model-based process development.
“While focusing on model development and integration for upstream and downstream processes, the project emphasizes stakeholder engagement and proactive regulatory dialog as essential elements in facilitating the implementation of model-based approaches.”
The extent to which vaccine makers can benefit from model-based approaches will depend on regulators according to the authors, who suggest alignment on how such technologies should be used is required.
“To ensure regulatory acceptance, novel guidelines, and internationally harmonized protocols are necessary as digitalization of manufacturing advances,” they note. “Models have far-reaching implications beyond process development, particularly in the manufacturing stage. They are the key elements of digital twin and real-time model-based control strategies and can significantly improve the efficiency of manufacturing processes when integrated with real-time data.
“However, currently, there are limitations in applying models for online monitoring and control of biopharmaceuticals as they become subject to FDA and EMA software regulations due to their direct impact on CPPs [critical process parameters].”
