What is CMC Manufacturing?
Chemistry, Manufacturing and Controls. These activities are known as CMC. All stages of the drug development life cycle, after drug discovery involve CMC. During preclinical drug development, the proper analytical methods are validated to monitor the product.
Featured CMC Manufacturing Sessions at AsiaTIDES
February 26-28, 2019 in Tokyo, Japan
Process Development and GMP Manufacturing of DNA Adjuvants
Satoshi Inoue, Ph.D.
Scientist, Research & Development Division
GeneDesign, Inc., Japan
Antisense Oligonucleotide Purification Process: Successes and Challenges During Scale-up
Robert Gronke, Ph.D.
Senior Principal Scientist, Technical Development
Biogen, USA
NittoPhase® HL, High Loading Polymeric Solid Support for Efficient and Cost-Effective Oligonucleotide Synthesis
Mohammad Ahmadian, Ph.D.
Senior Director
Kinovate Life Sciences, A Nitto Company, USA
Utilizing NMR for Oligonucleotide Characterization
Thomas Brown
Senior Scientist – Oligonucleotides
Intertek Pharmaceutical Services, United Kingdom
Introducing Green and Sustainable Solvents in Liquid Phase Peptide Manufacturing Processes
El Djouhar Rekaï, Ph.D.
Head of Development & Manufacturing Process
PolyPeptide Group, Belgium
Peptide Quality Attributes and USP Standards
Ranjan Chakrabarti, Ph.D.
Vice President & Head
Global Biologics Lab and Standards, United States Pharmacopeia, India
Cost Efficient Peptide Purification via ZEOsphere DRP Mixed-Mode Chromatography
Jurgen Machielse
Business Development Director
Zeochem AG, Switzerland
Featured CMC Manufacturing Sessions at TIDES US
May 20-23, 2019 in San Diego, CA
CMC Development Concept for Synthetic Peptides
Tanja Huth, PhD
Group Leader QA/RA Project Management
Bachem AG
Supply Chain and CMC Considerations during Development of Lumicell’s Cleavable PEGylated Peptide-dye Conjugate for Fluorescence Guided Surgery
Daniel Harris, PhD
Director of Drug Manufacturing
Lumicell
Spinraza Regulatory CMC Experiences
Mia Kiistala
Associate Director Regulatory Affairs
Biogen