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 thus creating more life saving products and addressing more health care needs.

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.

In short The “digital plant” and the use of various modern manufacturing technologies that go along with digital transformation promise greater efficiency and quality thus greater added value.

Ongoing changes in the life-sciences industry are putting ever greater pressure on pharma and biotech manufacturers to make continuous changes to the way they operate. Expanding price controls industry-wide have created a strong need to optimize operating budgets and prioritize investment in the development of new products. To drive continuous innovation and profitability requires better use of the data they already have and the building of more efficient manufacturing processes. 

Another driver for digital transformation is the shift from batch to continuous production. Continuous production allows for equivalent production volume with a much smaller capital investment and facility footprint. Manufacturing capital investment can be delayed until later in clinical trials when manufacturers have a clearer picture of a new therapy’s success. Higher capacity with a smaller footprint, all delivered with lower risk, makes a compelling argument for the transition to continuous manufacturing. Successful operation of these smaller, faster, and more flexible continuous manufacturing lines requires scalable digital transformation solutions.

A third key driver for digital transformation is ensuring supply chain reliability and efficiency. As organizations take advantage of modular and scalable solutions for development in labs, clinical production, and commercial production, these organizations are finding that their systems are easier to integrate, operate, and audit. This translates directly into savings, with many organizations achieving 5–10% improvement in asset availability, as well as similar or even higher gains in production, safety, and quality. These gains can provide a competitive advantage and ensure that patient supply and safety requirements are realized

Therapies produced for our unique genetic makeup are both tremendously exciting and uniquely complex for life-sciences organizations. Recent regulatory approval of the first CAR-T cell therapy product delivers incredible benefits to the public. For the first time in human history, patients can receive individualized treatments that change lives. As these targeted therapies become more and more prevalent, manufacturers will need to adapt to the new challenges created by new processes. 

Because personalized medicine requires complete traceability to ensure that the right manufactured therapy gets to the right patient, extensive chain of identity management is becoming central to CAR-T success. To maintain the timeliness, pace, and traceability necessary to deliver life-saving personalized therapies to patients, manufacturers are leveraging electronic scheduling systems with material collection/tracking software and manufacturing execution systems to ensure the patient therapy is properly planned, manufactured, and delivered back to the patient in the required timeline. 

In the small/flexible facilities delivering more traditional therapies, digital technologies such as digital twin modeling, [Industrial Internet of Things] IIoT integrated measurements, and augmented reality are driving improvements in quality and regulatory compliance. Additional focus will be put on alignment between maintenance, operations, quality, and planning so that data such as equipment maintenance records, batch manufacturing records, and out-of-spec quality results can be correlated across processes with context. This data integration/use leads to real-time release, optimized inventory management, and overall efficiency improvements

Regulatory interest

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. 

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.

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.

On the same note and to cope with the global trend , Paris-based  Sanofi announced it has inaugurated the opening of its first new digital manufacturing facility for biologics production in Framingham, Massachusetts. The digital-enabled aspect of the manufacturing plant is designed to leverage better use of data to optimize manufacturing processes and increase efficiencies and its considered a world class manufacturing facility with ongoing paperless production.

The company indicates that the factory will speed up the company’s recent transformation of its Industrial Affairs organization, focusing on biologics. The facility will be paperless and is expected to decrease the time it takes for products to transfer from development laboratories to the manufacturing plant and then to the marketplace

Sanofi indicates that it has several pilot programs across its network of facilities, but Framingham is “the first ‘digitally born’ facility.” Similar digital changes have been made in legacy plants. The company indicates it plans to move forward with digital transformation initiatives in Toronto, Canada; Suzano, Brazil; Waterford, Ireland; Sisteron, France; and Geel, Belgium.