Course Description:
Solid-phase synthesis is predominantly used today for the manufacture of oligonucleotide therapeutics. Impurities in the oligonucleotide API need to be tightly controlled and major impurities need to be characterized depending on the clinical stage of the program. This presentation discusses major classes of impurities and where they originate from such as raw materials, like phosphoramidites and the solid support, ancillary reagents, the synthesis process, and degradation.
Who should participate:
- QA Manager
- QA Staff
- QC Chemist
- QC Manager
- R&D
- Regulatory
- Student
The live version of this recording took place on during the USP Workshop on Therapeutic Peptides and Oligonucleotides:
Regulations and Quality Standards on March 4, 2022
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speaker:
Hagen Cramer
Chief Production Officer
QurAlis Corporation