ON DEMAND WEBINAR: Integrated CMC Development of Gene Therapies
Therapeutics that manipulate gene expression are a rapidly growing segment of biopharmaceuticals that address unmet medical needs. However, gene therapies usually include both nucleic acid and protein components, exponentially increasing the complexity of the development tasks needed to meet the Chemistry, Manufacturing, and Control (CMC) requirements of the FDA.
Topics covered in this webinar:
- Strategies to accelerate analytical and formulation development of gene therapy drugs
- Characterization approaches for drugs containing both protein and nucleic acids
- Methods needed for process and analytical control of gene therapy drugs
Who should attend:
- Analytical Development Scientists
- Formulation Scientists
- Gene Therapy Researchers
- Vaccine Development Scientists