June 2021: From the Editor

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We’ve reached midyear 2021 and our last regular issue until September. You will receive our annual Innovators issue in August. Along with it will be the (also yearly) featured report summarizing presentations from the BPI Theater at the Biotechnology Innovation Organization (BIO) International Convention.

BPI strives to maintain a balance of thought leadership from different groups in the industry ecosystem: end users, academic researchers, suppliers, contractors, regulators, and consultants. And we focus on specific bioprocesses for each product modality — with important areas of intersection and a number of notable differences. In our May issue, we stepped away from our usual phase-specific themes to examine how modern facility designs are adapting to the needs of new modalities and advancing technologies. Some of that discussion continues this month. Is it convergence or divergence (and how do we know)? Single-use technologies have moved from bench- to industrial-scale applications, developers of cell therapies are embracing large-scale production realities (costs, scale-up woes), and we’re all beginning to benefit from commercial application of mRNA vaccine technology.

With so many technologies and applications at a crossroads, this month’s issue and featured report both took on a more conversational tone than we normally offer. This issue’s focus on advanced therapies brings insights about a fast-moving segment for which best practices are still being invented. The featured report highlights a topic we’ve not considered quite this specifically before: cell banking. How are current technologies and the needs of new modalities affecting management of cell-bank quality and stability?

So our overall topic of discussion this month is the use of cells as raw/starting materials: sourcing, preserving, and transporting them and managing their variability. What manufacturing modes provide the needed flexibility, scalability, speed, and efficiency for different therapeutic types? How are companies developing characterization and analytical tools that track the real behavior of cells in culture and in the human body? What assays apply at what stages? Are current technologies adequate for meeting regulatory requirements?

We also seek to balance our levels of coverage — from “basic” to “advanced,” as our technical-article focus boxes say. Throughout this past year of virtual networking, I have found it much harder than usual to engage in the sorts of informal conversations that helped me keep track of our readership in the past. So I encourage you to participate this fall in our second annual BPI Readers’ Choice Awards. As in 2020, you will have a chance to vote for your favorite articles in several categories from a year of issues (September 2020 – June 2021). Your input certainly will reward those contributors whose work you’ve found most valuable and interesting. But it also provides the BPI editors with feedback on how well we are selecting topics that are relevant to your work, and it helps us guide potential authors toward addressing your concerns in the future.

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