In October, a McKinsey survey1 suggested that biopharma firms had accelerated their adoption of innovative bioprocessing technologies since the pandemic began last December. The researchers said development of SARS-CoV-2 vaccines and COVID-19 drugs combined with the need to quickly respond to market changes and disruption are the major drivers.
This take is shared by Kathy Brunner, CEO of digital consulting firm Acumen Analytics, who says R&D and manufacturing innovation are key to combatting the pandemic.
“Industry 4.0, Biopharma 4.0, Life Sciences 4.0, Lab 4.0, all are contributing to ramp capacity to identify, produce, and ultimately distribute vaccines necessary to flatten the curve and turn the course of the COVID-19 virus.”
Brunner cites advances in synthetic biology, gene synthesis platform technologies, and the use of advanced, in-line analysis systems as examples.
“Advanced analytics and data visualization of expected human response to potential vaccines allows researchers to conduct tests at scale even before vaccine candidates are administered to patients,” she tells GEN.
Industry interest in digital manufacturing was growing even before the pandemic, according to Brunner, who points to the emergence of new buzz words as evidence.
“Factory of the Future, Digitized Manufacturing, etc. There are many terms to describe the direction companies are heading as they move to be more efficient, more optimized, more competitive and ultimately delivering better patient outcomes,” she says.
Process development with real time analytics, process monitoring and understanding, and optimization are areas where AI, robotics, and automation have shown promise continues Brunner, who also cites regulatory support as a factor.
“Progress in understanding and support of these technologies by the FDA and other regulatory bodies has enabled the successful implementation and continued support of these solutions,” she explains.
The challenge industry faces now is keeping pace with the rapid evolution of digital systems.
“There are many components of Industry 4.0, some of which are not yet fully defined, or fully understood. Other components may emerge as technology is continually emerging. These new tools will certainly amplify future manufacturing solutions,” notes Brunner. “If Biopharma is to achieve 4.0 technical changes are necessary. More equipment needs to be digitally, or cloud enabled. Think Edge Computing, Smart Manufacturing.”
Data management is a case in point. “Industry needs to find ways of de-centralizing the large data centers and servers to miniaturized computing devices, leveraging wireless bandwidths with things such as IoT sensors throughout the supply chain,” she says.
According to Brunner, investment in IT systems is needed to enable the transfer and processing of large amount of data. Likewise, more staff education is required to enable the use and implementation of these systems.
And the investment will be worth it, points out Brunner, citing the greater efficiency and reliability that digital systems provide as a worthwhile goal.
“Biopharma product delays can cost between $1–13million in lost revenue for just one day,” she says. Patients are the consumers of biopharma products. Data and innovative technology are key to continue to provide better, safer solutions to the patients that need them.”