When putting together the manufacturing outlook article for our December 2017 issue, we encountered a small challenge — more content than could possibly be shoehorned into the printed pages of Life Science Leader magazine. Such problems can happen when you have 10 biopharmaceutical manufacturing executives willing to extensively share their thought leadership. Tackling such a quandary is just one of the reasons behind the creation of Life Science Leader’s exclusive Beyond The Printed Page online section of the magazine. We hope you enjoy this latest installment where six biopharmaceutical industry key opinion leaders reveal what manufacturing trends they find most exciting and why. If you like what you read, please consider subscribing 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 still requires a subscription. Oh, in case missed it, here’s a link to some additional biopharmaceutical industry manufacturing insight — What Transformative Technologies Are Biopharma Manufacturing Leaders Watching?
What Biopharmaceutical Industry Manufacturing Trends Do You Find Most Exciting?
Wolfram Carius, Ph.D., head of pharmaceuticals product supply, Bayer: With the change in modalities for pipeline realization and launch, the capabilities, capacities and organizational setup for technical development and manufacturing will change: new biologic entities (i.e., gene therapy, cells as product, viral vectors, etc.), highly potent low-volume new chemical entities, and IT-supported drug device combinations, to name just a few, will lead to:
Some of the countermeasures to tackle local entrance hurdles due to increasing requests for local value creation, fixed costs, and the strong need for a significantly lower cost of goods specifically for more personalized products include modular, small-sized prefabricated factories, risk-sharing agreements, standardized equipment, and material (e.g. single-use technologies for biologics). Continuous manufacturing might play an important role here in the near future, but an advanced regulatory environment will be needed to support these developments.
Philippe Luscan, EVP global industrial affairs, Sanofi: The “Factory of the Future” or smart factory concept is and something that we are already implementing aspects of at our manufacturing sites. For example, we are already taking steps to digitally enable our operations. But we are also applying some of the “Factory of the Future” concepts to address challenges of how to make our plants usable for clinical and commercial production, as well as for multiple products. These sites predominantly use single-use technologies (SUT), which allows them to be repurposed many times more quickly than the conventional sites relying on stainless steel vessels and piping. SUT factories can also involve connecting machines to create systems that interact intelligently with one another, and we can gather and exploit the data produced to increase efficiencies across manufacturing sites. Again, the big advantage with these new ways of manufacturing is the sheer flexibility and scalability it offers.
Esteban Santos, EVP operations, Amgen: The suite of technologies in our Next-Generation Biomanufacturing drug substance plant includes disposable components and high-yielding processes leading to the miniaturization of our factories. The facility is modular and reconfigurable, which makes it easier to expand capacity and introduce new products. I’m excited by what we've seen in going from concept to reality, and it is informing our future decisions. The success we’ve had gives us confidence and energizes me to continue to invest in these disruptive technologies in other areas of our network, like drug product manufacturing. At Amgen, we view our manufacturing capabilities as a competitive advantage for the company and we intend to continue to innovate to maintain that advantage.
Michael Thien, Ph.D., SVP and head biologics and sterile operating unit, Merck: The cost pressures on biopharmaceuticals will continue to drive innovations in high-productivity processes, making small footprints for manufacturing plants feasible. Portable/modular facilities and continuous processing operations will lead to designs that may not require large capital investments. And as personalized immunotherapies and cell therapies become more advanced, the need for economical, small-scale, single-patient batches will increase, leading to paradigm shifts in supply chain, logistics and quality management. With the likelihood of interchangeable biosimilars coming to the U.S. market soon, significant price competition is to be expected, and companies will have to be innovative to stay ahead.
Janet Woodcock, M.D., Center for Drug Evaluation and Research (CDER) at the FDA: It is exciting to think that more localized manufacturing facilities may bring the potential to reduce the complexity of drug supply chains. Flexible and agile manufacturing platforms also have the potential to enable production of a diverse portfolio of products to target small populations of patients, for individualized or precision medicines, or rapid response to market demand. From a regulatory standpoint, we’re certainly excited about the potential for technologies to allow increased quality assurance which could lead to performance-based regulation and more flexible regulatory oversight. There are challenges associated with realizing this potential. A new workforce and a change of culture will need to develop in industry and the FDA to adopt and evaluate new technologies. We will need to develop new regulatory standards and policies to address disruptive technologies and remove some perceived regulatory uncertainty. On the industry side, we acknowledge the difficulties of committing to a potentially large initial investment when adopting a new manufacturing technology.
Chun Zhang, Ph.D., head of process development and manufacturing, Evelo Biosciences: Several recent successful modular manufacturing facility deployments highlighted its advantage of fast construction, expansion flexibility and reduced up-front capital cost. “Modular facility” greatly levels the playing field for product innovators of various sizes and geographical locations. With increased product demand from Asia, Latin America and Africa, there is a significant need of being able to manufacture locally. However, the local expertise in design, construction and operation are quite low. “Modular facility” bridges this knowledge gap nicely. Leveraging recent advancements in process intensification and possible continuous manufacturing in the near future, the modular facility can achieve quite high production capacity with a much smaller footprint. Replicate modules can be easily added to existing ones or deployed in new locations. Facility commission is more predictable through a “cloning” approach, and companies can expand the capacity quickly if product sale exceeds expectation.