Beyond The Printed Page | May 9, 2018

What Transformative Technologies Are Biopharma Manufacturing Leaders Watching?

Source: Life Science Leader
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By Rob Wright, Chief Editor, Life Science Leader
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Coming Soon – Life Science Leader Exclusive – 2018 Biopharmaceutical Industry Manufacturing E-Book

When putting together the manufacturing outlook article for our December 2017 issue, we encountered a good problem to have — more content than could possibly be squeezed into the printed pages of Life Science Leader magazine. Such challenges can occur when you are fortunate enough to have 10 biopharmaceutical manufacturing executives willing to share their industry insights. Handling such a predicament is one of the reasons we created our exclusive Beyond The Printed Page online section of the magazine. We hope you enjoy this latest installment that asks five biopharmaceutical manufacturing executives to share their thoughts on what disruptive technologies could transform biopharma manufacturing. If you like what you read, please consider becoming a subscriber today at our current special rate of $49 (enter coupon code ED49). For while Beyond The Printed Page remains free, accessing all the great content Life Science Leader magazine has to offer requires a subscription.

What Disruptive Technologies Will Transform Biopharmaceutical Industry Manufacturing In The Next 3 To 5 Years?

Roger Connor, president global manufacturing & supply, GSK: Perhaps the single biggest technology transformation in the next 3 to 5 years will be digitalization and the accessibility of data. If we can access better information on how patients experience products, it’s going to open up new possibilities for research, treatment compliance and the way we make products available. Our industry has invested heavily in foundational IT platforms like enterprise resource planning (ERP), but this is just the start. As access and visualization improve, we will see far greater benefits in business planning, cost effectiveness and supply chain agility. This is essential, as e-commerce in many other industries has created a new level of expectation among buyers, and our products and their delivery will need to meet or exceed those.

Within manufacturing we are starting to see the potential for more real-time data analysis, and the use of artificial intelligence (AI) for problem solving and in-line testing for real time release. This in turn will lead to a higher level of automation, less human intervention, and more built-in data capture. This should free employees from much of the burden of manual data capture and make compliant record-keeping easier. We can also exploit digital technologies developed in other spaces (e.g., virtual reality gaming) to make procedural compliance and training in complex and sensitive operations more accessible and user-friendly.

Philippe Luscan, EVP global industrial affairs, Sanofi: Manufacturing is undergoing a revolution in new technologies. The use of disposables is not yet commonplace in routine manufacturing, but we can expect to see more of this in our industry over the next few years, and the effects of this technology is potentially transformative. For example, single-use technologies (SUT) promise to offer more flexible and efficient biomanufacturing methods, which allow us quick and more cost effective manufacturing. However, the industry is still very much on a learning curve with SUT. Standards and components for these technologies are not yet harmonized and innovation is ongoing, which creates challenges for integration into operations. As an industry we must work to optimize the benefits offered by SUT while also managing new risks they generate. As such, I find membership in organizations such as BioPhorum Operations Group (BPOG) and Bio-Process Systems Alliance (BPSA) to be valuable in keeping up-to-date with SUT best practices.

Esteban Santos, EVP operations, Amgen: There are challenges we’ve faced for decades in our industry such as the significant upfront investment required for design and construction of biomanufacturing plants, the long lead time to bring capacity online, and the associated high fixed costs. All of these create a context for high risk investments and limited operational flexibility, but there are technologies with the potential to make dramatic improvements, for example:

  • Miniaturization - Next-Generation Biomanufacturing is a revolutionary approach combining higher-yield processes with many new technologies including single-use bioreactors, disposable plastic containers and continuous purification processing. When you don’t need large stainless steel tanks and miles of pipes to produce biological products, it opens up a lot of possibilities. Our newest drug substance plant is 75 percent smaller than conventional facilities with similar output, and it can be brought online in half the time of a traditional biologics factory, reducing the upfront investment significantly, while minimizing the impact on the environment. We’re working on a similar revolution in drug product manufacturing.
  • Industrialization - In some aspects, biologics manufacturing processes remain fragile. The more we can apply science and engineering principles to our processes, for example with more robust and real-time in-process controls, the more resilient our factories become. This will lead to improvements in quality and reliability of supply.
  • Predictive analytics - Our processes are data-rich but we aren’t fully benefitting from that information until we can analyze in a way to provide actionable insights. My team and I recently had a chance to visit Brown University to see what they are doing with data visualization and there is tremendous potential for our industry. By leveraging the lower cost of computing technology, we will be able to apply Big Data, artificial intelligence (AI), machine learning and other emerging technologies to improve product quality, reliability of supply, and operational efficiencies.

Michael Thien, Ph.D., SVP and head biologics and sterile operating unit, Merck: While CHO-based [mAb] production processes will continue, cellular engineering with the goal of increased volumetric productivity and reduced cost of goods sold (COGS) will likely see advances. Advances in single use, modular processes with chemically defined media, using proteins engineered for manufacturability, will expand rapidly. The diversification of modality ranges from monoclonals to fragments, antibody conjugates, bispecifics and co-formulations will require the construction of flexible, multi-product manufacturing plants, and these will accommodate variations in processes and analytics. Finally, as we move from online monitoring to real-time release, we will see increased regulatory engagement. Automation in manufacturing plants and integration of all data systems will be foundational to supporting real-time process decisions, as well as real-time release approaches.

Chun Zhang, Ph.D., head of process development and manufacturing, Evelo Biosciences: The recent product approval [i.e., Novartis’ CAR-T treatment Kymriah (tisagenlecleucel), a first-ever cell therapy for a rare form of acute lymphoblastic leukemia] has generated a lot of excitement in the CAR-T segment. However, the current manufacturing process and analytical characterization in this segment remains quite primitive, and mainly conducted via integrating together several existing unit operations. This presents a great opportunity for product innovators, suppliers and academic institutes to collaboratively re-design (from the ground up) the process technology toward streamlining the manufacturing steps. The ideal process will be fully enclosed, modular and miniaturized. In addition, real-time product monitoring and characterization will be another major opportunity that will enhance product understanding and enable better process control and fast product release. Ultimately, advancements in these two areas will enable a fully automated and modular manufacturing operation, which allows a decentralized manufacturing supply chain, or ideally, bedside on-demand manufacturing. This will greatly expand the number of treatment centers and ease of patient treatment logistics. In addition, many smaller companies or academic institutes are more likely to be able to access the technology through CDMOs or academic core facilities, thereby reducing barriers to entry and leading to more clinical development.