April 2023: From the Editor

S Anne Montgomery

April 20, 2023

5 Min Read

New-Anne-2-228x300.jpgThe biopharmaceutical industry is continually reinventing itself. It evolved from a science-driven entrepreneurial approach and has worked over five decades to weave its network of business, regulatory, and process-development modes somewhat after the fact. The origin of so many bioprocesses in academic research laboratories prompted some of us in the editorial world to propose article series on “biobusiness 101 for scientists” back even in the early 1990s. Much of the industry’s progress toward its current form depended on adapting processes from the classical pharmaceutical and other sectors. Borrowing approaches from other long-established industries — e.g., chemical, semiconductor, automotive, and food — is an excellent way to prevent reinventing various wheels. But those wheels still have to be adapted for the needs of new vehicles and can end up doing a lot of spinning before they gain traction.

A number of the issues with which the current industry is struggling are mentioned and alluded to in this issue. Others have been repeated often enough that we start thinking of them as industry mantras: “Better, faster, cheaper.” “Begin with the end in mind.” “The process is the product.” BPI seeks out authors who convey progress, whether that is incremental or potentially disruptive. We also welcome many new readers each year who are new to the industry, so we still publish basic articles that introduce broader issues — always trying to focus less on history than on where we are headed and what progress has been made.

To that end, I am happy to introduce you to our new July–August issue concept, “Industry 360,” and suggest some topics that you might like to contribute some insights to. Working from the model of our 20th-anniversary issue in 2022, but with our sights set only on the past year or so, we are soliciting contributor insights into the industry’s coming year: What have you accomplished, and what do you want to see happen by the middle of 2024?

Offered in no particular order, the topics below are some that BPI authors refer to frequently as needing further discernment and adaptation to the biopharmaceutical sector. We invite authors from academic, consultant, and biomanufacturing organizations to submit ~1,500-word manuscripts similar to our usual “Focus On” offerings. Tell us what you expect and how you think the industry could gain those key moments of traction. Our submission deadline is 15 May 2023.

Process Analytical Technology (PAT): PAT tools can aid in (near-)real-time bioprocess monitoring and control. But amid all the hype, it is easy to miss the point that BPI’s managing editor makes in introducing his March 2023 eBook: “The biopharmaceutical industry agrees that PATs and automation will improve process consistency, enhance biologic quality, reduce production costs, and accelerate workflows. However, technologies for on- and in-line bioprocess monitoring generally remain in process development laboratories rather than being used on the manufacturing floor. Some difficulties stem from limitations with current sensing methods and technologies. Other problems relate to implementation and integration of existing information-technology (IT) solutions. And still other concerns arise when company leaders need to make a business case for investing in PAT infrastructure.” Do you agree? What examples might you offer, and what suggestions might you have for more fruitful lines of inquiry?

Training and Talent Needs: Academic and industrial training programs are proliferating, with a number of well-recognized organizations now promoting implementation of training approaches based on learning theory — beyond “step and repeat” to train, test, and certify operators of key equipment. At a glance, this seems like great progress, but some authors decry the lack of available talent nevertheless. Why is the industry still hurting for talent? Consider the second part of a 2021 interview (also conducted by BPI’s managing editor, https://bioprocessintl.com/manufacturing/cell-therapies/raw-materials-for-cell-therapy-production-when-the-process-is-the-product-ingredients-are-key) in which consultants Scott Burger and Bill Janssen emphasize the need for trained laboratory technicians in addition to graduate-level scientists. What progress are you seeing?

Communication: One huge lesson from the past three years has been a need for the biopharmaceutical industry to improve its communication to the public. Not only does the industry have to attract new talent and technologies from other industries, but it has to foster communication that cuts through all the misinformation that continues to get bandied around the Internet. How can you convince people that a biopharmaceutical career is an attractive proposition when too many members of your audience distrust both science and the pharmaceutical industry in the first place? Can you offer examples of approaches in your areas that might be good models?

Continuous Processing: The concept of continuous biomanufacturing is another complex issue. From an (overly?)optimistic goal of totally continuous processes, we moved to some continuous unit operations and process intensification. Full implementation goes back to the need for batch definitions, large-scale PAT systems, and comparability concerns. By now, what do you think about the future of continuous processing in the biopharmaceutical industry? Is it reasonable to expect it to work in processes that have to account for biological variability?

Automation, Artificial Intelligence — and Costs: The umbrella is potentially huge. To automate an entire biomanufacturing process involves, well, everything. From science to technology to statistics and math to training, the key connection becomes a need to monitor safety and quality while controlling final-product cost. Automation should help that happen. But to what extent will that be the case? Recent approvals show the costs of cell therapies rising, not lowering. What can the industry do?

Those are general topics suggested by the articles in this issue alone. We welcome your contributions to our Industry 360 issue by 15 May 2023. If you’d like to take advantage of this invitation, please let me know directly by email to [email protected]. And thank you all for your continuing commitment to the industry’s present and future.


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