By Chris Demers, Ph.D., Global Head, Plant Data and Analytics, Catalent Biologics
Moving from silos of automated or semi-automated manufacturing processes (Industry 3.0) to a full digitally integrated enterprise (Industry 4.0) is a journey that many manufacturers are only beginning. Biopharma 4.0, a sector-specific subset of Industry 4.0, encompasses several key innovations, including the widespread automation of business processes within a company, comprehensive data integration, and data interoperability between manufacturing and operations.
For Contract Development and Manufacturing Organizations (CDMOs), transitioning to Biopharma 4.0 is crucial – the data and expertise amassed by these manufacturers represent an integral asset for their customers working to innovate in an increasingly competitive and fast-paced market. By collectively pursuing the central tenets of Biopharma 4.0, the biopharma industry can realize gains that may increase speed to market, agility (especially should we experience future pandemics), and support the sector’s continued growth.
Digital Transformation Challenges
Digitally transforming an organization in a highly regulated industry such as biopharmaceutical manufacturing requires overcoming additional hurdles that may not be found in other industry verticals. Like all transformative initiatives, the evolution starts by recognizing that the way plants are currently operated could be optimized. Whether it is paper batch records, multiple layers of transcription, an over-reliance on spreadsheets, or any of the other pockets of highly manual or analog processes, all contribute to inefficiencies and should be addressed throughout the digital transformation process.
As digital transformation projects move to execution, there is often an inherent resistance to change. For a regulated industry, some resistance is for a good reason, as the products are destined to be injected or otherwise consumed by humans. However, some of this resistance is based on a preconceived notion that there may be regulatory implications attached to the newly digitized data. As a result, the FDA released a guidance document, in August 2003, to address concerns over the Code of Federal Regulations Title 21 Chapter 11 (21 CFR Part 11), in which they stated that the intention was not to “discourage innovation and technological advances…” [ Part 11, Electronic Records; Electronic Signatures - Scope and Application].
All of this underpins one of the most important considerations unique to biopharma digital transformation: the support of the quality and regulatory organization. This guidance also extends to validation teams who play a key role in ensuring that any new digital system will meet 21 CFR Part 11 requirements. These key stakeholders need to be champions of change, also be well versed in the most up-to-date recommendations on electronic systems from the FDA, EMA, and other regulatory bodies.
Ultimately, the pursuit of quality is a central focus of digital transformation. There is a compelling link between automation, digitization, and quality. In the Biopharma industry, moving to electronic batch records, for example, instantly eliminates the potential for calculation or transcription errors. Moreover, investing in Process Analytical Technologies (PAT) shifts quality control from the laboratories to the facility floor, often with a real-time view of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), or both.
Beyond the cultural shift required for digital transformation, there is also a need for a solid digital strategy. All stakeholders within an organization must understand this strategy, from the CEO to the associates on the plant floor. A cohesive digital strategy ensures that every project is treated as a small part of a much larger picture. Gone are the days of simply piping all the data into a process historian or any other data endpoint, such as a laboratory information management system (LIMS) or some bespoke tool only used by the R&D organization. Instead, interoperability underpins every project – ensuring that all data flows to a central location for all stakeholders to access.
Standardizing Digitalization for Industry Success
For a CDMO, the push for Biopharma 4.0, and more specifically for data interoperability, extends beyond the organization to the entire industry. CDMOs are often faced with the challenge of exchanging data with customers in real or near real time, the challenge being that each customer has their own unique solution(s) to retrieving data. It is simply not possible to support every solution, for both technical and financial reasons. Fortunately, groups such as BioPhorum’s Digital Integration of Sponsor and Contract Organizations (DISCO) workstream – a collaboration between leading biopharmaceutical manufacturers, contract organizations, and software vendors – was formed to better facilitate the data interactions for tech transfer, manufacturing, quality, and supply chains among industry players. The organization, comprised of various companies at different stages of digital transformation, is working to define the integration points and data structures necessary to facilitate large-scale digital integration across the pharmaceutical industry.
Catalent is an active member of the DISCO workstream and is using the learnings from this group to help refine its Biopharma 4.0 strategy. The company continues with its strategy to focus on making data accessible in real-time, to all stakeholders, including those outside its organization. By pursuing standardization and interoperability, CDMOs can ensure that they can meet their customers’ needs regarding digitalization, data sharing, and regulatory adherence.
Strategies to Facilitate Digital Transformation
While collaborative and open innovation is key to furthering the central tenets of Industry 4.0, it can be a difficult sell for sectors as intensely competitive as the biopharmaceutical space. Maintaining control over projects, guarding proprietary information, and affording stakeholders peace of mind regarding their data are all integral considerations that must be addressed, in order to make Biopharma 4.0 a feasible and more widely adopted initiative within the segment. Part of standardizing digitalization and digital transformation for biopharma hinges on establishing strategies that allow for the autonomy of individual organizations, while enabling mutually beneficial data sharing and interoperability between organizations.
For a strategy to be successful, it must be adopted by the entire industry, and the pharmaceutical industry is unlikely to ever adopt a single vendor’s solution for data exchange. Instead, individual players may consider focusing on adopting technologies that can be easily incorporated into their existing architectures. For Biopharma 4.0, Industrial Internet of Things (IIoT) protocols such as MQTT or Advanced Message Queuing Protocol (AMQP) should be important focus of an organization's digital strategy. Catalent is currently working to leverage MQTT to connect all its existing assets and applications into a single place. These initiatives will ensure that the company can scale its digital transformation efforts quickly across its network of more than 50 sites, and that it is ready to connect to clients’ digital systems as well.
Most of the bio/pharma companies and CDMOs that make up the present-day biopharmaceutical industry are at a relatively early stage of their digital transformation journey. For smaller companies, the ability to partner with a CDMO that can provide them insight into their product’s journey through features such as a web portal or other accessible, connected platforms, can be a critical advantage. CDMOs that can curate and contextualize data for their customers will also be afforded a distinct advantage in the greater market, as sponsors and CDMOs work to leverage the data to improve manufacturing processes and shorten time to market.
Embracing Change for Better Outcomes
Creating closed-loop systems that link CDMOs to their clients and the greater supply chain will be essential to coping with the uncertainties of the future. One of the biggest hurdles that sponsors and CDMOs can face in connecting data is in making the leap from laboratory to manufacturing scale. Ensuring that data is linked in a way that allows manufacturers to leverage early data to inform later large-scale processes represents just one of many crucial but often overlooked facets of pharmaceutical production. Additionally, the pursuit of Biopharma 4.0 represents an important opportunity for companies to create efficiencies that would otherwise be solved by increasing headcount, a difficult ask since recruitment, training, and retention of personnel with the right skill sets can be a challenge.
The push for change in the pharmaceutical industry broadly, and at the manufacturing level with its need for continuous, sustained production, may often be seen as a barrier to large-scale shifts in processes or procedures. But such shifts are critical for an industry that is increasingly pioneering the innovation of complex, sensitive, yet transformative therapeutics. Although many companies, concerned with the rigors of validation and regulatory compliance, are reluctant to embrace new technologies until proven, a shift in mindset may afford the industry better data, processes, efficiency, and results.
Catalent’s Strategic Vision for Implementing Biopharma 4.0
At Catalent, we take a patient first mentality to all transformative projects. With this lens it becomes clear that digital transformation is no longer a “nice to have” but a “must have” as we work to speed time to market while maintaining the highest levels of quality. We also recognize that we are just a piece of the global supply chain, collaborating across the industry through organizations such as DISCO to develop innovative solutions to rethink pharmaceutical manufacturing. Together we can modernize our manufacturing processes to deliver lifesaving treatments to our patients faster and cheaper than ever.
Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.
Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 19,000 includes more than 3,000 scientists and technicians.
Headquartered in Somerset, New Jersey, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, visit www.catalent.com.
More products. Better treatments. Reliably supplied.™
About the Author
Chris Demers, Ph.D., Global Head, Plant Data and Analytics, Catalent Biologics
Chris Demers works at the intersection of process automation and digital transformation, where he serves as a thought leader on the biomanufacturing plant of the future. Since joining Catalent in 2020, his primary focus has been to help define and deliver Catalent's Biopharma 4.0 strategy. Prior to Catalent, Chris was at Lonza, where he was a subject matter expert on laboratory automation and process analytical technology (PAT). He holds a doctorate in Biomedical Engineering from the University of Maine, Orono, Maine.