Scientific Program

The 2026 CMC Strategy Forum 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 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". We look forward to an informative Forum and hope to see you there. Be ready to network, collaborate, and expand your knowledge.

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.