04.11.26 -- Process Control, Vibe Coding, And Comparability In Biosimilars

This weekend’s editorial focus is on quality and process control, which was the topic of a recent “Better Biopharma” podcast episode with Richard Moroney, Ph.D., managing director at Stat Consulting, who had plenty of advice for organizations pursuing greater process control.

While process control is critical for any product, it’s become increasingly important for biosimilars. This was the focus of a recent Bioprocess Online Live event that featured Diana Colleluori, Ph.D., and Vince Narbut, Ph.D., of Biologics Consulting Group, as well as Cecilia Michel, Ph.D., of Alvotech.

In this industry, quality needs to be maintained across all products, tools, and systems. This guest column by Ricardo Torres-Rivera, CEO and president of Xevalics Consulting, warns about the dangers of “vibe coding” software (i.e., using generative AI tools to develop software through plain-language prompting). After all, software engineering is its own discipline for a reason. Torres-Rivera urges leaders to consider what’s at stake when quality is not built into software and to be wary of generative AI’s propensity to bypass institutional knowledge to deliver an output.

Before you enjoy the rest of your weekend, be sure to check out some selected content from our partners below!

Tyler Menichiello              
Chief Editor, Bioprocess Online

Cytiva offers guidance on minimizing hold-up volume and reducing dilution after PUPSIT for higher yields and less waste (More)

AST explores the pros and cons of barrel filling and tip filling syringes – and why barrel filling comes out on top (More)

An expert lineup from W.L. Gore & Associates demonstrate a cycling protocol that uses fast loading and non-loading residence times and rapid CIP out to 100 cycles (More)

Roche CustomBiotech’s blueprint for in vitro glycoengineering enables precision in protein glycosylation, and risk-managed integration after initial purification (More)

Bio-Rad Laboratories explains how ion exchange resins act as therapeutic carriers for advanced drug delivery in cancer and inflammatory diseases (More)

Samsung Biologics shares a white paper that addresses the industry’s downstream processing scale and efficiency challenges with complex biologics (More)

Ecolab explores how novel affinity Purolite resins prevent aggregation, and target alternative binding domains, in complex antibody purification (More)