Manufacturing innovation and collaboration with technology developers will be vital to maintaining the supply of medicines in future public health emergencies, according to the organizations behind a new study. The research—called the Global Biopharma Resilience Index—was carried out by Cytiva and consulting firm Longitude. The aim was to rank biopharma capabilities and resilience in 20 countries, scoring each on five factors critical to meeting demand during a public health crisis.
The study also revealed some major shortcoming chains, says Cytiva chief innovation officer, Dirk Voelkel, PhD.
“We identified challenges in supply chain, talent, research and development, manufacturing, and government policy and regulation that require attention and focus to solve,” he explains.
To develop greater manufacturing “agility” biopharmaceutical companies will need to invest in innovative technologies, notes Voelkel, citing product quality as an example.
“Automation is a key to improving the quality of drug products, increasing the speed to market as well as lowering manufacturing cost,” he continues.
Automation requires data. And, although many biopharmaceutical companies capture process data during each unit operations, they are not always good at using that data, says Voelkel.
“Today most biopharma manufacturing sites are operating in digital silos according to the Digital Plant Maturity model that was developed by the BioPhorum Operations group,” he points out. “The next maturity level is connected plants, so capturing process data and sharing it with control systems is essential to break out of the silos.”
The events of last year have led the biopharma industry to be more willing to innovate, according to Voelkel, who adds, “The rapid development of vaccines for COVID-19 use has demonstrated the innovation capability of this industry.”
Evolving needs
Collaboration with technology suppliers will be a vital part of this process, and Voelkel maintains that evolving biopharmaceutical industry needs will drive the development of next generation bioprocessing systems.
“We rely on tight collaboration with our customers on early-stage processes to understand needs and requirements and to enter joint developments. One example of such collaboration is the innovation challenge on processing solutions for exosomes, which are not yet established, but have great potential for diagnostics and drug delivery solutions,” he tells GEN.
“We closely observe pharma pipelines to anticipate needs for new technologies to support growing modalities and therapies. When the first CAR-T cell therapies were emerging, we created specific solutions for this growing segment and we are now a leading provider for solutions of these breakthrough therapies.”
At present, Cytiva has over 100 ongoing collaborations, from academics to start-up companies, Voelkel says, citing partnerships with MIT and—in Ireland—the National Institute for Bioprocessing Research and Training (NIBRT), as examples.
“We have joined the industrial liaison program of MIT (MIT/ILP) jointly with our sister company Pall Biotech to get fresh insights through access to the MIT faculty and the extensive start up community at MIT with over 2,000 startups,” he continues.
“Secondly, we just became a member of NIIMBL to advance the manufacturing of biologics, where biopharma companies, technologies providers, academics, as well as government organizations collaborate to jointly tackle the biggest challenges of our industry.”
