Pharma 4.0: the accelerated digitization of the pharmaceutical industry.
The concept of pharma 4.0 it is taking hold in the pharmaceutical sector. The unique characteristics of this industry are driving investments in digitization. In fact, ABI Research foresees that total revenue from digital factories will exceed $ 4.5 billion by 2030, and pharmaceutical manufacturers’ spending on data analytics is expected to grow 27% and be worth $ 1.2 billion in 2030. Not surprisingly, these companies seek improvements in their productivity and optimization of operations, with special interest in tasks of tracing.
While regulators encourage, rather than stifle, innovation, the competitive dynamics of the industry require pharmaceutical companies to optimize production lines to maximize throughput for as long as a drug is subject to patent protection. Once they expire, generic manufacturers must create as many products as possible. The use of analysis of data will increase performance.
In this sense, the consulting firm indicates that going from making drugs and vaccines in batches to optimizing the process with continuous manufacturing will be essential to increase yields. “But active ingredients are immediately susceptible to change. The batch should be discarded if the formulation falls outside the accepted parameters. Suppliers will have to invest in testing to help develop digital twins of their operations so they can prepare their production lines for continuous manufacturing, “he says Michael Larner, an analyst at ABI Research.
Another digitization approach for pharmaceutical companies is eliminate paper from your operations. “Collecting and storing data through paper-based processes runs the risk of reducing productivity and increases the likelihood of production line errors due to clerical errors,” says Larner. FDA 21 CFR Part 11 is one way the FDA is promoting the adoption of digital technologies by publishing criteria for submission of electronic records to the organization and processing of electronic signatures.
The prevalence of paper illustrates the progress pharmaceutical companies still need to make in relation to digital transformation. In this sense, ABI Research proposes a five-stage digital maturity model that describes the progress made and the steps required by manufacturers to optimize their operations. Larner explains: “Currently, pharmaceutical companies are in stage 2 where they have a modern factory, but lack foresight and struggle to adjust production, or stage 3 where they have started to implement digital transformation, but lack experience in reconfiguration production lines. In the next decade, many companies will upgrade their existing facilities or build greenfield sites (new sites), and their operations will either digitally transform (Stage 4) or operate without humans (Stage 5). “
A notable example of advanced facilities is the digitally enabled, continuous manufacturing facility of Sanofi in Framingham, Massachusetts, where all processes are paperless and operators use digital collaboration tools, data analytics and augmented reality (AR) solutions so they can make decisions and adjustments in real time.
There are a myriad of suppliers that help the pharmaceutical industry to digitize and optimize processes. Appian, COPA-DATA, Metastorm and Metronik, and Neo PLM are some of the suppliers that help companies in the Pharma sector to move from the pre-digital stage (Stage 1) to connecting their plants (Stage 3). Emerson, Falkonry, Siemens and Seeq provide solutions that support drug production from stage 3, the connected plant, to being predictive (stage 4) and eventually adaptive (stage 5).