The State
of Bioprocessing

Brian Gazaille

Managing Editor

Increasing complexity in antibody design has been highly consequential. As antibody products become more diverse in structure and more targeted in their effects and indications, development and manufacturing processes are changing to follow suit. Flexible, intensified manufacturing has become key to operations — and often at more modest scales than were used during the days of blockbuster biologics.

Chris Spivey

Industry Relations & Strategic Partnerships Director

Three forces stand out: miraculous science — gene editing, CAR-T, and self-amplifying mRNA; China's production emergence alongside a shift in US outsourcing patterns; and the regulatory uncertainty that follows from both — partly scientific, partly political.

Brian Gazaille

Managing Editor

In the realm of CHO-expressed proteins, folks should keep tabs on intensified and continuous biomanufacturing. Multicolumn chromatography methods and other continuous downstream processes are gaining traction in commercial operations. Because of such advances, end-to-end continuous processing seems to be within reach. At the same time, several critical topics remain conceptual underdogs — industry continues to optimize removal of process- and product-related impurities from drug substances and products, partly because of growing understanding of coeluting impurities. And industry is starting to think carefully about polysorbate degradation in formulated drug substances and products.

Chris Spivey

Industry Relations & Strategic Partnerships Director

Self-amplifying mRNA — Arcturus's KOSTAIVE® was the first sa-mRNA COVID vaccine approved anywhere, and Replicate Bioscience has an sa-mRNA rabies vaccine in the works. Pandemic-scale manufacturing more broadly: the plasmid DNA backbone underpinning vaccines, treatments, and diagnostics still requires two to three months (often longer) to produce GMP-grade material — that mismatch is a design flaw the Bundibugyo outbreak has made painfully clear. Universal vaccines — Jonathan Heeney's DIOSynVax super-antigen work, Versatope's flu program, Stanford's "integrated immunity," Moderna's mRNA-1083 arc, and Centivax's Centi-Flu 01 all deserve close reading. Platform consolidation, where automation drives clear winners in ATMPs. And organoids — non-animal-modeling mandates and NASA's Artemis II organ-on-chip work are pulling them out of ADME into front-line phase-zero and phase-one alternates.

Brian Gazaille

Managing Editor

Accessibility and affordability will present both significant challenges and opportunities. Those might not be technical bioprocessing concerns, but they merit careful consideration. Industry needs to bring down production costs in ways that enable more patients to afford treatment — that is true for conventional mAbs and advanced therapies alike. And industry needs to do more regarding health equity, working with and within low- and middle-income countries (LMICs) to support regional infrastructure for biologic and vaccine manufacturing.

Chris Spivey

Industry Relations & Strategic Partnerships Director

Improving patient accessibility through cost-of-goods discipline — driven by automation, standardization, and the digitalization of both production and supply-chain delivery.

Brian Gazaille

Managing Editor

Upstream, culture media have come back into the limelight. Historically, media have taken a back seat to cell-line engineering, but companies are beginning to think about culture media as key optimization points and cost levers. Downstream, continuous chromatography is garnering a lot of discussion — though we've also had a surge of interest in filtration's impact on downstream recovery. More broadly, contributors are keenly interested in how to implement AI in their workflows, especially given the need for GxP compliance.

Brian Gazaille

Managing Editor

I started reporting on biopharmaceuticals just before the COVID-19 pandemic, which fundamentally changed how drug makers operate. Before the pandemic, industry conversations seemed to emphasize volume and speed — upstream discussions focused on maximizing bioreactor size, power, yield, and processing speed. The pandemic reinforced the need for speed, but companies now seem ready to "work smarter, not harder," operating at more modest volumes and with increased attention to optimizing time, work, and resources. Some of that mindset is reflected in growing interest around in silico modeling and small-scale, high-throughput screening.

Chris Spivey

Industry Relations & Strategic Partnerships Director

Time to market has become much more vital, and COVID accelerated it dramatically. I've called it the "Amazoning of life sciences" — an ugly term, I know, but it captures the expectation shift.

Brian Gazaille

Managing Editor

I already mentioned healthcare equity, but I'll say it again — with a twist. Several drug developers and manufacturing partners are advocating for "one health" approaches, acknowledging the interconnectivity of human, nonhuman animal, and environmental health. I encourage readers to think about how they can work within that paradigm, whether that means reinforcing sustainability commitments or supporting programs that prioritize vaccine equity. Some companies are making great headway on equity and sustainability, yet there is need for much more movement on those fronts.

Brian Gazaille

Managing Editor

Our readers most appreciate articles and presentations that have practical bearing on their work. It's fun to learn about a new analytical instrument or reagent, but folks inevitably ask: how can I integrate this into my group's work, and what benefits and limitations are we likely to find when we do? I don't think suppliers underestimate the need for practicality — but readers really appreciate studies with detailed protocols and frank discussions about what a technology can and cannot do.

Chris Spivey

Industry Relations & Strategic Partnerships Director

Context for materials-transfer agreements — which need to reflect the increasing complexity and sophistication of the underlying science. More is done at the cutting edge than in any era previously, and disaster lurks more encroachingly for it.

Brian Gazaille

Managing Editor

Readers appreciate detail and candor. Writers naturally want to show off the most promising results, but readers want to know the good and the bad to evaluate whether a new technology or processing method will work in their organizations. During peer review of our technical articles, we ask writers to provide as much data as possible so readers can see the true utility of the work.

Chris Spivey

Industry Relations & Strategic Partnerships Director

Real overall costs.