March 2020: From the Editor

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My first business trip each year usually is to Washington, DC, in January. There, the CMC Strategy Forum and WCBP symposium (sponsored by CASSS have an excellent track record of setting the stage for topics that will play out through the rest the year. The combined event draws significant US Food and Drug Administration participation. So we also look forward to their help in focusing our attention on key regulatory issues and updates.

With continuing focus on well-characterized biologics, WCBP centers on assessments of comparability and stability, with emphasis on regulatory expectations. Products discussed this year included proteins, antibodies, vaccines, bi- and multispecifics, and cell/gene therapies. Analytical discussions highlighted ways to reduce time and costs of development, highlighting promising new technologies and reinforcing the benefits of collaborations of all types.

Regulatory sessions at WCBP have included more speakers each year from countries still developing their overall pathways and compliance regimens (e.g., Argentina, Brazil, Canada, Germany, Ghana, Jordan, Paraguay, and Peru this year). Some agencies are “preaccession” members of the International Council on Harmonisation (ICH), just beginning to develop their procedures and looking forward to full membership in that international body. Presentations described regulatory harmonization and convergence in West Africa, efforts to shorten market-authorization timelines in Brazil, the impact of ICH Q12 on regulatory activities in Canada, and a set of priorities being developed for submissions and approvals in a post-Brexit world.

Stability/comparability concerns are expanding across a broader range of product modes and process approaches than in past years. Lessons learned from “traditional” bioprocesses are enabling developers to leverage existing platforms (for example) for bi- and multispecific design and optimization. Speakers offered insights into conducting degradation studies, and one reported on an accelerated chemistry, manufacturing, and controls approach for an Ebola vaccine. This year’s “hot topic” workshop (based on attendee suggestions from last year) focused on reducing comparability exercises for managing older master cell banks. A lively discussion highlighted the need to focus on true risks, negotiate terminology confusion, determine the types of stability studies needed (and under which circumstances), and compare protocols for demonstrating control of product quality. Comparability issues specific to updating legacy vaccines were raised in a separate workshop.

There was much more, of course. For example, talks about manufacturing 4.0 and digitalization pointed to the importance of managing “real-world data N” and maintaining record accuracy across a product life cycle. Some speakers suggested different approaches to analytical testing (e.g., profile-based rather than attribute-based assays/methods). An Amgen presentation highlighted ongoing work from the Multi-Attribute Method (MAM) Consortium. I can’t offer a comprehensive “meeting report”
on this page, but I hope to bring you many of these topics in article form over the coming months.

Peruse this year’s program at https://www.casss.org/general/custom.asp?page=WCBP2000 and let me know what you would like to see more of in BPI.