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. The novelty of these gene therapy drugs require the design of new analytical methods to satisfy the intended purpose outlined by the CMC strategy.
Discriminating analytical methods are needed for the protein and nucleic acid components as well as for the fully assembled biotherapeutic. These methods are leveraged to characterize the drug and efficiently conduct formulation and process development. Done correctly, the early development activities will aid identification of the critical quality attributes that are needed to demonstrate drug product quality.
In this webinar from Wolfe Laboratories, learn about:
- 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