This issue introduces an adjustment to our themes of coverage, which for much of BPI’s history have rotated from production to processing to manufacturing, with the introduction a few years ago of the “bioexecutive” focus in December. My somewhat pedantic nature always was slightly offended by the idea of separating “manufacturing” from two other themes that were also elements of manufacturing themselves, even though it was mostly just a matter of semantics. And our new product-development theme encompasses much of what that older one did, but in a more logical way. Think of “upstream production” and “downstream processing” as relating to the drug-substance aspects of biopharmaceutical development/manufacturing, and you see not only what the product-development theme covers by contrast (drug-product aspects), but also why it is necessary.
More than that, upstream and downstream are process-focused themes. And we must never lose sight of the product itself — and perhaps more important, its role in healthcare. We frequently have discussed product characterization here in the pages of BPI, but more often than not it has been in relation to process development. That is, we were concerned with what the results of such testing could tell us about whether your process was robust, repeatable, and in control (and thus producing high-quality biologics). And that is important, especially, to the growing biosimilar segment of our industry.
However, product testing also is — and some might say, more essentially so — about patients. It is meant to prove safety and efficacy as well as quality. Regulations aren’t the only reason we care about such things; they just codify accepted means of achieving those goals. From discovery (which in our world is less about defining targets than defining protein function) through scale-up to formulation, fill–finish, and clinical trials, biopharmaceutical candidates face a gauntlet of analytical and bioanalytical testing. And despite our presenting an ELIspot manuscript in our very first year — Lathey JL, et al. Validation of Pretrial ELIspot Measurements for Predicting Assay Performance During a Clinical Trial. BPI 1(9) 2003: 34–41 — BPI’s coverage of the safety and efficacy angles has been admittedly light.
As this month’s articles by Advant et al. and Parameswaran et al. exemplify, we are open and committed to presenting such information as part of our product-development theme. Occasional articles such as Bruno Speder’s “Bacteriophages, an Alternative to Antibiotics “ (BPI 14(6) 2016: 18–21, 27) have focused on product classes, too, as have supplements on biosimilars, regenerative medicine, and antibody–drug conjugates (though their coverage often has been process-centric) . And I’ve tried to complement those approaches somewhat with my ongoing Spotlight series on “niche diseases.”
This evolution of the old manufacturing theme remains the place for our drug-product focus as well: discussions of formulation, delivery, filling and finishing, and so on. But we want to make clear this added emphasis on testing: We may be BioProcess International, but that name always has been meant to cover the “whole development process” for biologics, not just little-p bioprocessing. Ultimately, the theme is more about patients than not — as much as our other themes can be said to be more about cells and their output.
Some BPI readers are engineers, some are biologists, some are marketers, some are managers . . . all day jobs that require problem-solving in many forms. But ultimately, we are all patients. Quality may be important to your company’s bottom line, but safety and efficacy are matters of life and death — for everyone.