June 13-15, 20233 Day Online Training Course
11:00AM-1:30 EST
Below is What Will Be Covered:
The course will be 2.5 each day
European Attendees: 3:00pm-5:30pm Greenwich Mean Time GMT/ 4:00-6:30pm CET
US attendees: 10:00am-12:30pm EST / 7:00am-9:30am PST
Each day there will be a break as well as time for Q&A and group discussion. Timed agenda will be made available closer to the course date.
Introduction to Therapeutic oligonucleotides
- Different types of oligos and their function in medicine
- Manufacturing process
- Chemical and physical properties
- Sources and types of impurities
How to develop an initial Quality Target Product Profile
- Working from the dosage form to the Critical Quality Attributes of the drug substance
- Specifications and purity targets for oligonucleotides including specific controls, control of impurities for non-clinical and early clinical batches
Analytical Methods
- Purity and impurities
- Assay
- Identity including sequence confirmation
- Other methods
Quality by Design and Control Strategy
- Critical Quality Attributes (CQA’s) and the identification and control of Critical Process Parameters (CPP’s) through risk assessment and experimentation
- Application of principles to the phases of oligonucleotide manufacture
Updating the QTPP and specifications for late phase supplies, registration batches and process validation
- Challenges related to oligonucleotides
- Challenges in working with CMO’s
- Challenges in scaling up, batch size
- Challenges in drug product specifications and methods
Regulatory considerations
- Impurity reporting and qualification levels
- Expectations for other impurities (e.g. potential genotoxic impurities)
- Dealing with limited batch history