CMC: A Developmental Approach to Ensure Drug Quality – from Small-Molecule Drugs to Biotherapeutics

Join our experts, and by attending this forum, you will:

• Enhance your understanding of the role of CMC (Chemistry, Manufacturing and Control) in drug development and quality assurance.
• Gain further insights into how to leverage developmental experience in small-molecule drugs for biopharmaceuticals and biosimilars.
• Deepen your understanding of process chemistry, formulation strategies, and analytical development and QC processes.
• Understand more the key differences between quality attributes and testing methods of small-molecule drugs versus biotherapeutics (mAb).

Event Overview

Presentation #1: An Overview of Key Differences of the CMC Processes in Small-Molecule Drugs and Biotherapeutics

A solid understanding of Chemistry, Manufacturing, and Control (CMC) processes is essential when transitioning from small-molecule drug development to biotherapeutics. This session offers a comparative overview of CMC best practices, highlighting how foundational quality approaches in small-molecule development do—and do not—translate to biologics.
The presentation will cover core elements such as process chemistry, formulation development, analytical methods, and quality control (QC). Emphasis will be placed on manufacturing and purification strategies, including contrasts between chemical synthesis and fermentation-based bioprocessing. Differences in quality attributes, testing methods, and regulatory expectations (generics vs. biosimilars) will be discussed.

Presentation #2: Translating small-molecule development to complex generics and biosimilars

Translating experience from small-molecule development into the more complex domains of generics and biosimilars presents scientific, regulatory, and operational challenges. This session examines how established practices can inform new approaches, particularly in the development of biologics. Speakers will explore key differences in physicochemical and pharmacological properties, testing requirements, and critical quality attributes (CQAs). The CMC workflows for small molecules and biologics will be compared in detail, with attention to analytical development, PAT implementation, and quality control under biological complexity. Regulatory and business perspectives—including generics vs. biosimilars—will be addressed through practical examples.

Who should attend?

Biopharma professionals and laboratory scientists who want to enhance their understanding of best practices in quality and regulatory processes.

• Industry experts engaged in analytical procedure development and validation.
• Stakeholders involved in method lifecycle management and regulatory compliance.
• Quality control and quality assurance personnel.
• Regulatory affairs professionals.
• Academics eager to learn about method development and the regulatory requirements in the pharmaceutical and biopharmaceutical industries.
• Sales and marketing staff for analytical and processing equipment.