An Overview of Key Differences of the CMC Processes in Small-Molecule Drugs and Biotherapeutics
Key Learning Outcomes
- Understand what CMC means in pharmaceutical drug development, including the Chemistry, Manufacturing, and Control framework that ensures drug products are consistently produced to quality standards. Also, learn how the CMC organisation, processes, and regulatory responsibilities are structured within a typical pharmaceutical company.
- Discover how the CMC processes for small molecule drugs, covering API process chemistry, formulation, analytical development, and QC, compares to the equivalent workflow for biologics, which includes cell line development, bioreactor fermentation, bioprocessing, purification, and formulation.
- Examine the roles of analytical development and quality control within the CMC function, such as method development and validation, stability programmes, release testing, generation of certificates of analysis, and their contribution to regulatory submissions.
- Investigate how quality attributes and QC testing methods compare between small molecule drugs and monoclonal antibodies, highlighting shared approaches, differences, and additional characterisation needed due to the greater structural complexity of biologics.
Event Overview
This session by Dr Michael Dong offers a clear, practically grounded overview of CMC processes in pharmaceutical drug development, contrasting small molecule drugs with monoclonal antibodies to highlight both the universal principles of drug quality assurance and the notable differences in how these principles are implemented across different modalities.
The presentation begins by defining CMC (Chemistry, Manufacturing, and Control) and explaining its importance: ensuring that clinical trial materials and commercial drug products are safe, effective, and consistently produced to specifications. The typical CMC organisation is outlined, showing how process chemistry, formulation, and analytical development sit alongside QC, regulatory affairs, project management, and manufacturing within a multidisciplinary project team structure.
The session then explains the CMC process for small molecule drugs, from API synthesis and purification through formulation development to analytical method development, validation, and QC release testing, before making a systematic comparison with the monoclonal antibody development pathway. For biologics, the process from antigen identification through hybridoma development, CHO cell line selection, bioreactor fermentation, affinity and ion exchange chromatography purification, and sterile filtration is described in clear terms, using the Genentech bioprocessing workflow as a concrete reference.
Quality attributes and testing methods are then compared side by side across both modalities. Shared approaches including identity, potency, purity, and impurity testing are identified alongside the significant differences: dissolution testing and solid-state characterisation for small molecules; size exclusion chromatography, ion exchange, peptide mapping, host cell protein, endotoxin, and structural integrity testing for biologics. The session concludes by emphasising the practical message that small molecule CMC experience translates meaningfully into biologics but only when the fundamental differences in production, stability, and characterisation requirements are fully understood and respected.
Who Should Attend?
Scientists, quality professionals, and regulatory specialists seeking a structured, comparative understanding of CMC processes in small molecule and biologic drug development.
- Analytical Scientists and Chemists moving from small molecules to biologics CMC
- Quality Control and Quality Assurance Professionals in pharmaceutical and biopharmaceutical settings
- Regulatory Affairs and CMC Submission Specialists
- Formulation and Process Development Scientists
- Early-career Scientists and Graduates entering pharmaceutical development
- Project Managers and CMC Subteam Members coordinating cross-functional development activities
- Technical Managers overseeing CMC functions across modalities
Unlock Additional Educational Resources
Register today for Michael’s presentation and gain access to exclusive bonus content, such as the insightful panel discussion on “CMC: A Developmental Approach to Ensure Drug Quality – from Small-Molecule Drugs to Biotherapeutics”.
Dr. Michael DongPrincipal ConsultantMWD Consulting (USA)Dr. Michael W. Dong is a principal consultant at MWD Consulting, focusing on consulting and training services on HPLC, pharmaceutical analysis, and drug quality. He was formerly a Senior Scientist in Analytical Chemistry and Quality Control at Genentech, a Research Fellow at Purdue Pharma, a Senior Staff Scientist at Applied Biosystems/Perkin-Elmer, and a section head at Celanese Research Company. He holds a Ph.D. in Analytical Chemistry from the City University of New York. He has 130+ publications and five books, including a bestselling book on chromatography (HPLC and UHPLC for Practicing Scientists, 2nd Ed., Wiley, 2019). He is an advisory board member of LCGC magazine.
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