Biopharma will “go digital” as more firms recognize the benefits of innovative, data-driven manufacturing, according to Novartis, which announced plans to digitize its business last year. The company said the project would begin with the technical operations group that manages the manufacture of innovative medicines and generics drugs sold by Sandoz.
“The aim is to build an enterprise-wide data and analytics platform to transform the way medicines are manufactured and delivered,” according to company spokesperson Carsten Seum. “Digitization has significant potential, in particular to accelerate production throughput times and drive overall productivity. We are focusing on creating end-to-end transparency along the value chain and recently started to add predictive capabilities driving forward-looking improvements in daily process execution for individual sites. In Supply Chain Management we are scaling up a digital optimization approach for determining the economic order quantities to drive productivity between NTO and affiliates. We are exploring digital solutions to empower our workforce to work increasingly remote.”
Digitized manufacturing is a “must win” for the drug industry, adds Seum, who says implementation is not without challenges. “Most IT/OT-systems need to be GMP-validated and doing so requires that a firm establish standard, core digital systems across all manufacturing sites to effectively scale digital solutions on top of it.”
This type of manufacturing requires a workforce with an evolving set of technical skills. The best approach to achieving such competencies, in Seum’s view, is to encourage the sharing of ideas and to create a space where different departments can interact.
“A key success factor for a successful implementation of digital approaches also is a culture characterized by curiosity, inspiration, and teamwork,” he explains. Empowered teams are a key enabler for digital transformation.
The idea of controlling manufacturing operations through a centralized system is an established concept. The aviation and automotive sectors began digitizing a decade ago. For the drug industry, however, this approach is still a novelty. And the lack of experience—particularly at the regulatory level—is a hurdle, according to Seum, “Regulatory acceptance is a key element. New technologies like Blockchain require an industry-wide approach and regulatory support,” he says, citing the FDA’s recent pilot study on the subject as a positive move.
Despite the challenges, Seum is confident others will follow Novartis’ lead and embrace innovative digital manufacturing.
“Adoption of new ways of working will help accelerate the transition,” he points out. “In addition, demonstrating continuously improved value provided by digital processes will accelerate digital products’ adoption.”