The digital transformation of biopharmaceutical manufacturing is continuing at a rapid pace as companies attempt to mine the sources of data available. Innovations include predictive analytics, big data analytics, and creating the digital plant. Digital transformation offers a mechanism to revise its business model, to improve production processes, to design new drugs faster by using artificial intelligence to screen compounds and to increase responsiveness to customers. Furthermore, the volume of data processed by pharmaceutical firms shows no sign of slowing down. This means pharmaceutical companies must act quickly in terms of building core internal digital capabilities and moving beyond their traditional IT functions to all areas of the business.
It is not only pharmaceutical companies who are driving digital technologies, but there is also an expression of interest from regulators as well. Perhaps the most important is the U.S. FDA’s Pilot Program under the Drug Supply Chain Security Act (DSCSA), which requires the Agency to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. The DSCSA initiative is intended to enhance the security of the pharmaceutical distribution supply chain, and consider any pilot projects conducted prior to the enactment of the law.
These potential new technologies include blockchain. Blockchain is software that provides a digital ledger system for records and log transactions, by grouping them into chronologically-ordered blocks. This makes it ideal for tracking supplies, and ensuring that required storage conditions have been achieved and that goods have not been tampered with. Blockchain is quickly increasing in interest for pharmaceutical companies, based on success stories relating to other sectors of the economy like financial services and energy suppliers. Furthermore, the blockchain for pharmaceuticals project is important, given that by 2023, members of the U.S. supply chain will need the processes and systems in place to meet the DSCSA requirement for an interoperable, electronic tracing of pharmaceutical products at the packaging level.
To facilitate blockchain, competing solutions are emerging which seek to integrate directly into a healthcare company’s existing global infrastructure. This integration will allow for the secure exchange of critical and confidential information with authorized partners in an open, interoperable format. Such a program will be a step towards helping companies meet the final 2023 DSCSA deadline requiring full unit-level traceability across the supply chain.
Outside of regulatory drivers, a number of pharmaceutical companies have been exploring innovative technologies. Some examples are examined below.
Digital analytics for process improvement
GE Healthcare has built a digital data exchange collaboration program with another manufacturer, Amgen. The aim is to use data analytics to better understand the relationship between raw material variability and process performance during manufacturing. What can be leveraged from such analysis are better ways to ensure consistent and predictable biomanufacturing performance. The collaboration rests on the efficiency of the data exchange capabilities between the two companies, as well as their willingness to share data.
Creating a digital company
The “digital plant” and technologies that go along with digital transformation, such as robotics, data analytics, artificial intelligence, and the industrial Internet of things (IIoT) can deliver greater efficiency. For these reasons, Eli Lilly and Company is advancing the implementation of these technologies to its pharmaceutical manufacturing organization.
The digital plant can accelerate improvements. For example, technology can reduce ergonomic risks through robotics lifting boxes and ensure quality through real-time analytics rather than after-the-fact testing. These technologies can also drive cost efficiencies. Of the different digital transformation tools, robotics and advanced analytics are seemingly the most mature and thus the ones that will be easier to implement in the shorter-term.
In further news, Teva Pharmaceuticals Industries is to work with Insilico Biotechnology where Insilico’s technology for predictive biomanufacturing will be applied to Teva’s manufacturing processes. This will allow for more efficient production processes.
The technology will assist with assessing the vast quantities of data generated from bioprocessing. By being able to satisfactorily review this data presents new opportunities for solutions to improve manufacturing operations based on predictive biomanufacturing. The focus is on optimizing biologics production processes through the use of computational simulations.
A new Tandem 4.0 platform has been designed to assist with pharmaceutical operations by using augmented reality. The technology can be deployed in the laboratory, on a manufacturing line, and or within cleanroom environments. Through this system, users can connect globally and engage in problem-solving in real-time. The aim is to assist organizations with avoiding process deviations and to help to prevent manufacturing delays.
Whereas virtual reality immerses the user in a fully artificial computer-generated environment, augmented reality overlays virtual three-dimensional graphics on the real-world environment. The aim is to ‘augment’ the way users view everyday life (or work tasks) and, in doing so, reveal more information. The platform also allows for customized user menus, plus there is the facility for voice commands. The use of voice can be switched on to guide users through each processes step. The platform also permits single- or multi-user drawing annotations to be made on any captured image.
Image capture also allows for remote and live support. Here experts can help to bring attention to a specific aspect of a machine that is showing a process or performance machinery. This works by remote experts dropping three-dimensional augmented reality arrows into the real-world environment back in the pharmaceutical facility. As well as using the platform directly, users can stream sessions from smartphones or tablets.
Tandem 4.0 is an example of the adoption of augmented reality in areas of complex manufacturing, like pharmaceuticals. One report revealed that 30 percent of Global 2000 companies have reported they are set to try out both virtual and augmented reality as part of their digital transformation strategies.
In pharmaceuticals, this includes applications like visualizing physiological processes, or “handling” models of chemical compounds and molecules, as well as the assistance with helping review machine operations, as with the Tandem concept.
Augmented reality also paves the way for digital twins. These are virtual representations of physical systems. Acting as a virtual replica of the physical environment, a digital twin can be used in advanced ways to automate, optimize and connect systems, and the adoption of digital twins technology is set to become big. Digital twins can be applied to design and to assist with operations, such as providing real-time data about the condition of a process or an item of equipment; or extending to an entire system, building or town.
While the technology can examples cited are interesting, have disruptive potential, and signal the future., many biopharmaceutical companies will find it challenging to determine which technologies to adopt and which what initiatives to scale up and how quickly. The vision of digital success will take time to realize, and there will be misses and well as success. Important lessons from other industries include developing a digital transformation agenda; ensuring the projects are shared across the organization and not just retained within the IT department, and that digital embracing culture is developed from within, beginning at the top in the C-Suite.