Understanding The Difference Between Small-Molecule Drugs And Biotherapeutics

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

• Enhance your comprehension of the fundamental differences between small-molecule drugs and biologics, including monoclonal antibodies (mAbs) and various novel drug modalities.
• Recognise the testing requirements, critical quality attributes (specifications), and regulatory expectations and challenges faced in the pharmaceutical and biopharmaceutical sectors.
• Learn how to apply and adapt any developmental experience with small-molecule drugs to biologics.
• Understand what does and does not translate from small-molecule drug development to biologics, and where thoughtful adaptations are critical.

Event Overview

Presentation #1: An Overview of Key Differences of Small-Molecule Drugs and Biotherapeutics: Perspectives and Quality Attributes

Understanding how foundational quality approaches for small-molecule drugs translate—or fail to translate—to biotherapeutics is essential for modern drug development. This session provides a comparative overview, starting with small molecules and their chemical properties, manufacturing, and testing practices. It then examines biotherapeutics, highlighting their biological complexity and bioprocessing techniques.

Key topics include differences and similarities in physicochemical and pharmacological properties, formulation strategies, analytical testing requirements, and critical quality attributes (CQAs). The discussion also explores how quality models developed for small molecules may inform biologics development and the impact on drug purity. Regulatory frameworks and market access considerations—generics versus biosimilars—will be addressed, with a case study illustrating practical implications.

Presentation #2: A Journey of a developmental scientist from mAbs to Small-molecule Drugs and Novel Drug Modalities

This session follows the evolution of a developmental scientist navigating between monoclonal antibodies (mAbs), small-molecule drugs, and emerging drug modalities. Special attention will be given to manufacturing and purification strategies, comparing chemical synthesis with fermentation and bioprocessing methods.
Discussions will explore how quality control principles shift across modalities, focusing on process design, PAT tools, and regulatory expectations. Business aspects such as translation strategies and the differences between generic and biosimilar pathways will also be considered. A comparative model will be introduced to guide quality assessment across platforms, drawing on real-world examples and regulatory insights.

What you need to know:

Dual-time broadcast, with starting times as follows:

Wednesday, 24 September, 2025

• Broadcast #1 (Europe / Asia): 10:00 h GMT (London) / 11:00 h CET (Paris/Berlin) / 14:30 h IST (New Delhi) / 17:00 h SGT (Singapore) / 18:00 h JST (Tokyo)
• Broadcast #2 (North America / Europe): 08:00 h PST (Los Angeles) / 11:00 h EST (New York) / 16:00 h GMT (London) / 17:00 h CET (Paris/Berlin)

Duration: Approximately 60 – 90 minutes, incl. Q&A.

• Registrants attending this online event’s live broadcast sessions will receive a ‘Certificate of Attendance’.
• Join the BioQC user community for ongoing discussions after the event.

Who should attend?

Biopharma professionals and laboratory scientists seeking to enhance their knowledge of optimal practices in quality and regulatory processes, including:

• Experts from the industry engaged in the development and validation of analytical procedures.
• Stakeholders participating in the management of the method lifecycle and ensuring regulatory compliance.
• Personnel in quality control and quality assurance.
• Professionals in regulatory affairs.
• Academics keen on understanding method development and the regulatory standards in the pharmaceutical and biopharmaceutical sectors.
• Sales and marketing teams for analytical and processing equipment.