Summary
This 3-day CMC formulation training is designed to keep you up to date on emerging strategies and practices relevant to the formulation for nucleic acid and peptide nucleic acid fields. You will learn how to develop best formulation practices for these important molecules which are relevant for intended uses and regulatory compliance to avoid costly project and market-approval delays.
Learning Objectives
- Understanding emerging trends in the field of DNA, RNA and PNA
- Various forms, manufacturing methods, modifications, uses, and storage
- The Regulatory frameworks and expectations relevant for formulation
- Differences in various stages – R&D, Process Development and Manufacturing
- Key starting materials, classifications, references, and standards
- Formulation risk management
- Quality by Design (QbD) and how to implement best practices for formulation
- Formulation CMC strategies and design for DNA, RNA, and PNA
- Study design and best practices across stages
- Analytics, testing, qualification, validation, and characterization
- Data across stages and leveraging towards Pharma 4.0
- Data and sample retention requirements
- Learn how to conduct a comparability study
- Avoid delays in clinical development and market approval
- How to deal with post-approval changes
Key Topics
- Non-GMP & materials, classifications & systems
- Regulatory compliance, drug classes & routes of administration
- Quality-by-Design & study planning
- DNA, RNA & PNA biophysical & chemical properties relevant to the formulation
- Formulation for DNA, RNA & PNA
- Analytical methods
- Change management: FMEA de-risking, tech transfer & CMC activities
- Analytics, storage, stability, comparability & retention
- Testing, qualification, validation & characterisation
- CMC assays & Control Strategy
- Comparability and post Manufacturing process changes
- Handling & Supply – Product considerations, logistics, storage, supply
Who should attend?
- Formulation Scientists
- Purification & Downstream teams
- R&D Scientists, Engineers & Managers
- Process Development Scientists & Engineers
- Manufacturing Scientists, Engineers & Managers
- Analytical & QC/QA Scientists, Engineers & Managers
- QPs & Trainee QPs
- Regulatory Affairs Managers
- CMC Professionals
- Product Stability Managers
- Senior Management & Executives
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Digital and LinkedIn certificates
Trainers
Len has over 30 years of experience in both industry and academia. He is a member of a regulatory advisory group for ATMPs. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. His regulatory and licensing experience covers the MHRA, EMA and FDA.
Formulation & CMC for Nucleic Acids
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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