INTERPHEX recently posed a series of questions to two of PDA’s noted subject matter experts on Pharma 4.0, data, digitization and more. Read the insightful perspectives of Toni Manzano, Co-founder and CSO, Aizon, and Martin Düblin, Managing Director, One One Eleven GmbH, about how new technology is driving the pharmaceutical industry forward.

INTERPHEX: What recent success stories have come out of the Pharma 4.0 industry?

Toni Manzano:  Pharma 4.0 is synonymous with digitization and each new process that is fully digitized, such as an upstream operation like bioreaction, downstream operations, and packaging, is a success story in itself. The Industrial Internet of things (IIoT) is becoming a standard for data acquisition, and cloud technologies are taking more space in the field of new software for managing lab and production.

Artificial Intelligence (AI) is demonstrating value in the field of analytics along the three PV stages, and there are several published initiatives where AI and Machine Learning bring value in deviation management, process understanding, and operation control for yield optimization. To succeed in this journey, most of the Pharma 4.0 elements are required to work together.

We are also seeing that regulation is progressing in this direction, with the Computer Software Assurance (CSA) proposal, which should replace the classic Computer System Validation (CSV) approach.

In sum, all the ingredients are ready to prepare the best recipe to maximize value to the patient.

Martin Düblin: The understanding is growing regarding what digitalization might and will bring. Compelling solutions are in place and are delivering convincing results. What’s most interesting about all of this is that the technologies are available and have been implemented for many years within other market segments. Therefore, Pharma and life science can follow and learn from other industries. For example: Consider the use of six axe robots who handle complex procedures. Independent of environmental conditions, time and day, and other factors, such robots act 24/7 with a precision of 1/100 and uninterrupted. In our industry, the core problem with a human’s particle emission in class A and B grade can easily be solved with robots. This and other such initiatives provide positive impacts for the end user.

INTERPHEX: What has the ROI looked like in terms of implementing new processes of the Pharma 4.0 model?

MD:  It can be stated with confidence that the ROI is highly significant. Improved quality, increased production capacity, higher utilization, less downtime, advanced speed, faster responsiveness, and promising simplification are boosted by Pharma 4.0. There is a pre-investment needed for the first steps, as is usual for new technologies. However, after they are adopted, and the company has experienced the learning and growing experiences, the pay back is huge.

TM: The ROI is highly dependent on the process where Pharma 4.0 is applied. Unfortunately, there are no biopharma companies where 4.0 is currently fully deployed. Some examples of ROI measured from my experience include: 17% annual energy savings, one $4 million batch savings by applying AI, a 61% reduction in the total number of runs, and a 53% boost in process effectiveness in ultrafiltration process just by connecting data silos and applying AI, and a 93% reduction in pooling time in downstream purification using IIoT and AI.

INTERPHEX: With a digitalization strategy in place, what should success look like?

TM: Data visibility and data aggregation capabilities (e.g., such as power reports, fast cross references), less cost in IT infrastructures and more specialized technological skills, fewer downtimes and more knowledge, faster GxP decisions for batch release (electronic batch release), faster insights for deviation management and risk assessment, and proactivity regarding impact mitigation are examples of the benefits of digitalization.

MD: There is also a benefit from the overall competitiveness for the company, increased motivation within the whole organization, improved efficiency, higher flexibility for diversity, and stronger sustainability, just to name a few criteria of success.

INTERPHEX: What are some key steps to implementing these strategies?

MD: The integrated approach is essential. Pairing this with an open-minded driver will reap the largest benefit. Create some distance between what and how something is done today and collect experiences from others as reflection to use to guide your decisions. But, most important, digitalization has to be “kicked on.” Let’s take a look: An initial phase for digitalization takes roughly one year. A second year follows for initial implementation, and a third one is needed to get digitalization into operation. Taken together, that’s three years from now, while the market still acts much faster. Waiting puts the company at constant risk of losing market position, disrupting business, and reducing the company’s ability to effectively serve patients.

TM: The most crucial step is to establish a top-down strategy. Working with pilots created by small units without clear support from the C-level is to condemn the initiative. Digitalization is a commitment, a set of new good practices, a value that everyone supports from his or her respective role, and an explicit agreement toward the evolution of old patterns to deliver safe, quality, and effective drugs to the right patients at the right time.

INTERPHEX: How can companies ensure they are using their data to operate in the most efficient way?

TM: There are digital mechanisms based on automatic audits that are used to identify data islands and data well shared. The cloud seems to be the ideal tool to accelerate good practices about using data in an efficient way. The ALCOA+ and FAIR principles are good guidances to ensure maintenance of the regulatory framework under this innovative way of working with data from a decentralized perspective. Therefore, companies that are data centric rather than user centric have a competitive advantage because data is at the service of final users requiring a specific set of skills that shift the digitization culture across the company.

MD: And, as with other technologies, with regard to data, Pharma may reflect what and how other industries are doing things, implementing adapted versions that suit our industry’s needs. However, an important factor comes to the forefront: business changes, and such changes necessitate other types of job profiles. The transition to better data management requires data scientists, data analysts, programmers, robot engineers, and system integrators to arrange these new streams so they are most valuable to the users.

INTERPHEX: What are the best pieces of advice you can offer in terms of quality management, energy management, and reporting?

MD: Consider that all needs may be delivered and solved in a digital way. But, in order to digitalize requests, the first step is the cleaning and standardization phase where the base is formed to allow for the next step in the process. Make sure to approach with an open mind – free yourself from existing understandings, learn from other disciplines, and get your initiative directed.

TM: Best practices are following the data centricity criteria described above. Energy management and reporting are being transformed by cloud technologies, presenting an added value by means of the software standardization across sites. On the other hand, quality management is evolving toward a dynamic perspective based on AI capabilities like deviation reduction by means of anomaly predictions and root cause analysis through supervised and unsupervised AI models.

INTERPHEX: With recent changes in the industry, how can companies go from being reactive to proactive, especially in the year of the COVID-19 pandemic?

TM: Good data and consistency in records are the main ingredients necessary to derive appropriate knowledge from the data at hand. Being proactive means being able to anticipate potential issues, and AI is the best analytical tool to provide these types of insights. AI, real time data acquisition, and shared information is the key to robotize human cognition in critical and repetitive processes.

MD: As reacting is one of the core problems in the industry, the digitalization is the major solution to turning business behavior in a proactive direction. As soon as data are in the hand and the user well informed regarding what information to take from that data, the reactive responsiveness is in place and can provide support to solve this challenge.