September From the Editor September 2016

Some issues of BPI more than others emphasize to me the interdisciplinary nature of our audience. One example: I am happy to bring you the latest consensus paper from the CMC Forum series. In its discussion of host-cell protein control strategies, the authors write of their goal to “bring industry, academics, and regulators together for generating integrated perspectives on HCPs and their control.” Those three groups — industry, academics, and regulators (government) — constitute three major categories of our readership statement. So to meet their professional needs, we know that BPI’s subject matter has to span a range of topics from regulatory to business to science and technology.

From the start, BPI has separated its content into two primary categories — nontechnical (“Focus on . . .”) and technical articles — with a third smaller category to highlight presentations of supplier data. I think it is because we try generally to balance the number of pages devoted to technical and nontechnical articles that some people see BPI as a nontechnical publication. At least, that is what a few people have said to me. And it takes me aback because we editors consider this to be a technical publication overall (especially after spending a full morning editing a large complex figure or table). We are not an academic-style journal, of course, so that is probably what those commenters meant to say. And our industry “niche” is not huge, but it is larger and broader in subject matter than the specialty audiences of highly technical journals.

But readers who step out of life-science research and begin to navigate the landscape of commercial manufacturing face increasing pressures to adapt to new technologies and accelerated timelines. We want to help them stay abreast of regulations and quality issues that affect their work — the essential framing elements of compliance and quality activities affecting the future of a biopharmaceutical product from its earliest stages.

There is sometimes a fine line between what is technical and what is not, and we editors admit that some of our decisions might seem a bit arbitrary. For example, a high-level discussion of quality themes often would appear as a “Focus on Quality,” but this month’s CMC Forum paper feels more technical than some other papers in that ongoing series. And both “Focus on” articles this month are chock full of data and technical/mathematical language even though they are discussing business and compliance topics. Our heavy focus on compliance/quality issues this month highlights a complex web of intersecting process steps, regulatory strategies, analytical evaluations, statistical expertise in risk-analysis, and process-control strategies.

A maturing industry has more at stake and can be resistant to change. That is understandable when the stakes get higher and the timelines are accelerated. But the greater the confidence generated through increased exposure to analytical methods, and the greater understanding overall about overlapping/parallel needs among different development groups, the more smoothly those changes may proceed. BPI can be your partner in training, in decision-making, and in professional development.