May 2023: From the Editor

While editing and proofreading an issue, we often see statements that suggest other intriguing angles to explore. But deadlines loom, and our notes to follow up on those ideas can get lost in the shuffle. And because we pursue a good portion of our manuscripts (cue image of editor chasing after conference speakers in crowded hallways), those notes have value. Seemingly casual statements in talks and manuscripts can help us focus our acquisition efforts.

Working through those mental “loops,” adding incremental bits of insight in hopes of an aha moment can be frustrating. “But what’s new?” Debates continue over single-use, stainless-steel, and hybrid systems; continuous and batch processing; and artificial intelligence (AI), digitalization, and iterations of “4.0.” Questions arise about risk mitigation, product variation, and process platforms; the industry’s resistance to change and regulators’ comfort with new technologies; differences in available resources and capabilities between small and large companies; and inevitably, the cost–quality–speed balancing act.

I often mention that I want to hear from our readers and that our readers are our authors. Note that we do try to suggest topics and “prime the pump,” so to speak, when we talk with you. Pullquotes in some articles often highlight questions or point to problem resolutions. With technical papers, we try to pull out key milestones. Those might be specific to a company’s work, and other groups could have similar areas of exploration and perhaps different approaches to the same concerns.

When you see a forward-looking or even problematic statement, consider sharing your thoughts with us. That’s what we hope to see in manuscript proposals. Do you have a contrary opinion? Maybe your colleagues would like to contribute as well.

Reading the past couple of issues and featured reports brought the following questions to my mind, for example:

• How can process analytical technology (PAT) move into manufacturing-scale operations?
• In planning for site audits, what AI advances could facilitate a transition to automated, continuous monitoring as part of “virtual” product-quality assurance?
• Does focusing on upfront pricing preclude collaboration, shared risk, and simultaneous implementation? How do you balance these key elements for success?
• Digitalization might reduce repetitive tasks and free technicians’ time for more creative endeavors — but how do you make it palatable to those who fear that they could lose their jobs to automation? How are companies addressing this potential disruption through training and upskilling?

We’d love to see and share your concrete examples from experience in solving such problems. Drop me a note at [email protected].