Oct 25, 2021Rupa Pike, PhD
Rupa Pike, PhD, is the director of enterprise science and innovation partnerships at Thermo Fisher Scientific.
The COVID-19 pandemic undoubtedly changed the manufacturing of biotherapeutics, including cell and gene therapies (CGTs). Severe shortages of raw materials, a decline in research and development, staffing restrictions at good manufacturing practice (GMP) facilities, and reduced capacity at manufacturing sites exacerbated an already complex and challenging process to bring these therapies through development to commercialization.
Plasmids, media, and other ancillary materials crucial for gene therapy development are also essential for vaccine manufacturing and were funneled to the global fight against COVID-19. With resources and personnel understandably reallocated to COVID-19 related activities, many CGT research efforts were deprioritized and completely shut down, ultimately slowing new discoveries.
"Remote process monitoring and optimization are becoming increasingly common in biopharmaceuticals and could easily be translated into CGT development."
In GMP facilities where operators work in pairs, in addition to social distancing, measures were taken to ensure further protection with plexiglass barriers and extra personal protective equipment (PPE). Although this ensured manufacturing continuity, it reduced the efficiency and productivity of facilities already operating at limited capacity.
While the pandemic slowed CGT development, it accelerated potential regulatory pathways for new therapies. To get critically needed vaccines to market, regulatory agencies demonstrated a willingness and ability to approve innovative vaccines at an unprecedented pace. The steps taken by regulatory agencies could pave a new path for accelerated approval of experimental therapies that may be the only recourse for certain diseases. It is important to note that, in order to take advantage of regulatory fast-tracking, current bioprocessing and GMP manufacturing techniques need to evolve.
Automation is more commonplace in manufacturing of biologics and monoclonal antibodies, allowing for standardization that leads to consistent and reproducible results. Automation also contributes to safety and efficacy of the final product by reducing hands-on time and minimizing human error. Due to the manufacturing complexities, CGT workflows will require innovative approaches to automation. The solutions implemented during the COVID-19 pandemic have better positioned the industry to take advantage of automation and digital connectivity. Additionally, remote process monitoring and optimization are becoming increasingly common in biopharmaceuticals and could easily be translated into CGT development.
CGTs have the potential to transform how we deliver care for patients with limited treatment options. Though the COVID-19 pandemic may have highlighted the pitfalls of current practices, it has also demonstrated how quickly the industry can adapt and develop best practices for manufacturing of CGTs.