05.20.24 -- Addressing Challenges In Serialization For Complex Therapeutics

Implementing NGS technology for adventitious virus testing in viral vector vaccine development and manufacturing is crucial for ensuring safety. Gain insights for an optimized sequencing method.

The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning CGT research.

Learn how the use of human PSCs as starting materials for cell therapies is shifting and the potential PSCs hold to reduce cell variability and costs associated with cell line development.

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

Explore how the FDA's Project FrontRunner expedites cancer drug approval for early advanced metastatic cancer, emphasizing efficacy and safety in earlier clinical settings.

Addressing physical instability and high-viscosity issues early when developing ultra-high protein concentration formulations can reduce costs and improve patient outcomes.

Venkata Indurthi, Ph.D., discusses key considerations for RNA synthesis processes and methods, their impact on downstream production, and why different projects' needs may vary.

Standardized methods, materials, and analytics are critical for overcoming hurdles in the gene therapy space. Consider how a platform approach to fast-track AAVs can enhance quality and efficiency.