Identifying Cell and Gene Therapy Risk Factors
As the still-emerging field of cell and gene therapy continues to develop, it is helpful to sort risk factors by challenges and concerns.
Cell and Gene Therapy: Selecting the Right Vector
Selecting the right vector to achieve efficient and safe gene transfer is a crucial part of cell and gene therapy design.
Understanding the FDA’s Guidance on the IND Process for CGTs
The FDA’s Center for Biologics Evaluation and Research, or “CBER”, oversees the preclinical process for all cell and gene therapies.
How Does Gene Editing Work?
Gene editing works by using genetic engineering technologies to replace or inactivate genes, or introduce new or modified genes to treat disease.
Cell and Gene Therapy: Ex Vivo versus In Vivo
There are two primary approaches to unlocking the promise of cell and gene therapy: ex vivo and in vivo.
What are CQAs?: Understanding the FDA’s Critical Quality Attributes
Critical quality attributes, or CQAs, include safety, identity, sterility, purity and potency. Here’s what you should know.
Cell and Gene Therapy Balances Promise and Risk
Cell and gene therapy (also known as “CGT”) is an emerging field that offers new opportunities for treating a wide range of diseases, including cancer, genetic disorders, and autoimmune diseases.
Genetic CAR-T Therapy Holds Great Promise
CAR-T (chimeric antigen receptor T-cell) therapy is a type of immunotherapy used to treat certain types of cancer.
Cell and Gene Therapy Research Challenges
Cell and gene therapy research and development represents the vanguard of where science is going next, but it's fraught with many challenges.