Welcome to the CMC Strategy Forum North America

The annual CMC Strategy Forum North America will bring together industry, regulatory, and academic professionals to discuss key emerging CMC issues that affect biotechnology. The one-day program features speaker presentations, panel discussions, workshops, and networking opportunities that allow you to engage with fellow attendees in meaningful discussions on the latest CMC updates and issues in biotechnology. The 2026 Forum features two concurrent full-day tracks on the following topics: "Making Creative Protein Therapies a Reality for Patients" and "Right Dose, Real Impact: Strategies to Ensure Consistent Dose for Every Patient".

The Forum will be offered in-person as well as live-streamed to a virtual audience. Extend your in-person stay and maximize your knowledge-sharing experience by attending the back-to-back WCBP Symposium on January 27-29, 2026.

View the scientific program below or click this link to open the scientific program in a new tab. View the full Forum abstract below.

Forum Abstract

The biotechnology industry has entered a new era, moving beyond creating simple 'humanized' proteins to designing sophisticated molecules with enhanced specificity and efficacy against disease. This exciting new frontier includes Bi-, Tri-, and higher-order multi-specifics, multi-conjugate ADCs, and AI-designed proteins. While these innovations promise more effective treatments, they introduce significant CMC challenges that must be addressed to ensure successful development and delivery.

Another opportunity for industry is ensuring drug product content and uniformity. Control of the final product is paramount for patient safety and efficacy. We will examine the balance between drug product design, manufacturing process control, and release testing to guarantee that patients receive the intended dose, whether it's delivered in a vial, a single-dose device, or a multi-dose system. The forum will highlight how an acceptable level of variability is maintained through a comprehensive control strategy, including in-process controls and release testing with adequate acceptance criteria, all while adhering to regulatory guidelines and compendial requirements.

Join us at CMC Strategy Forum North America Winter 2026 as we explore the practical considerations for creating these novel proteins and gain a deeper understanding of the control strategies needed to enable consistent dose across dosage forms and delivery systems.

Frequently Asked Questions

"It is a great way to gain context for regulatory and quality work outside of your given organization." 
—Marlies Hager, CMC Strategy Forum North America 2025 Attendee

"CMC Strategy Forum North America is an excellent forum to have in depth discussion on highly relevant topics. "
—Christof Finkler, CMC Strategy Forum North America 2025 Attendee

Program Partners