E15-28: Drug Quality Fundamentals Part 2

Part 2: Quality Control of Small Molecule Drugs and Recombinant Biologics

Half-Day Course

Dr. Michael W. Dong, MWD Consulting, Foster City, CA

This course provides an overview of drug quality concepts, standards, regulations, and practices in clinical development and manufacturing in pharmaceutical and biotechnology industries.  You will learn the roles of quality assurance (QA), quality control (QC), and the chemistry, manufacturing, and control (CMC) drug development process in ensuring safety, efficacy and quality of drug products. It covers industry-standard processes such as qualification/validation, release testing, specifications, certificates of analysis (COA), stability and regulatory filing. Critical quality attributes (CQA) of large-molecule recombinant biologics are described and contrasted with those of small molecule drugs. The course discusses the challenges of maintaining drug quality in a global supply chain and the role of HPLC in these processes.  This course can be combined with “Drug Development Part 1” as a one-day course (E15-26); a discount will be offered over separately registering for the two half-day courses

This course will benefit scientists and non-scientists currently working in various disciplines of the pharmaceutical industry who want to improve their understanding of CMC, quality systems, analytical chemistry and quality control processes in the industry. This course is also useful for non-pharma scientists who seek a technical overview of challenges and opportunities for drug development and quality management (QA, QC, regulatory, supply chain management) in pharma related industries (pharmaceutical, biotechnology, generics, over-the-counter and nutraceutical industries). It is recommended that you have some fundamental understanding of biology, chemistry or biochemistry.

1.  Introduction to Drug Quality and CMC Quality Assurance Process
     * Quality attributes
     * Recent quality breaches
     * GLP, GMP, GCP, ICH guidelines
     * IND, NDA, CTA, QC / QA unit specifications
     * Quality by Design (QbD)
2.  QC of Small Molecule Drug Substance and Drug Product
     * Specifications
     * Release testing
     * COA
     * Impurities 
     * Stability
3.  Critical Quality Attributes for Recombinant Biological Products
     * Approaches to manufacturing and bioprocessing of monoclonal antibodies
     * Analysis of intact proteins, fragments, variants, glycans and other biological testing

Dr. Michael W. Dong
is a principal in MWD Consulting focusing on consulting and training services on HPLC/UHPLC, pharmaceutical analysis and drug quality.  He was formerly Senior Scientist in Analytical Chemistry and Quality Control of Small Molecule Pharm. Sci. at Genentech, Research Director at Synomics Pharma, Research Fellow at Purdue Pharma, and Senior Staff Scientist at Applied Biosystems / Perkin-Elmer.  He holds a Ph.D. in Analytical Chemistry from City University of New York, and a certificate in Biotechnology at U. California. Santa Cruz. He has 100+ publications and three books including a bestseller in HPLC (Modern HPLC for Practicing Scientists). He is an editorial advisory board member of LCGC magazine and American Pharmaceutical Review.

Recommended Text:
R. G. Hill and H.P. Rang (eds.), Drug Discovery and Development: Technology in transition,  2nd edition, Churchill Livingston, 2012. ISBN 978-0-7020-4299-7.