- Metabolic Stability
- CYP Interaction
- Permeability & Transporters
- Physicochemical Properties
- Protein Binding
Discovery PK and Toxicology
Gene Therapy is a rapidly growing frontier for biological and clinical research. For products to qualify for IND (Investigational New Drug) filing, BLA (Biologics License Application) or PMA (Pre-market approval application) filing, and clinical trials, analytical testing is required to ensure that all the presented parameters and descriptors are valid. Frontage Laboratories has expanded its Analytical Biologics Group to offer Cell and Gene Therapy Services to meet all kinds of testing needs of clients. For the past 5 years, Frontage has provided analytical development, methods qualification and validation, and sample testing for our clients to help push their products forward and to help our clients succeed.
Human cell therapy is a therapy in which viable cells are injected, grafted, or implanted into a patient in order to effectuate a medicinal effect, for example, by transplanting T-cells capable of fighting cancer cells via cell-mediated immunity during immunotherapy or grafting stem cells to regenerate diseased tissues. The cells used for cell therapy are usually stem cells, which include human embryonic stem cells, neural stem cells (NSCs), mesenchymal stem cells (MSCs), hematopoietic stem cells (HSC), etc. Some differentiated cells, such as tumor infiltrated Lymphocytes (TILs) and dendritic cells (DC) are also applied well and sound promising for cell therapy.
Human gene therapy seeks to modify or manipulate the expression of a gene or alter the biological properties of living cells for therapeutic use. Gene therapy is a technique that modifies a person’s genes to treat or cure diseases. There are a variety of types of gene therapy products, including Plasmid DNA, Viral vectors, Bacterial vectors, Human gene editing technology, and Patient-derived cellular gene therapy products. The most used viral vectors for gene therapy are AAV vectors and Lentiviral vectors.
The CMC Biologics Team at Frontage Laboratories is composed of extremely skilled scientists who focus on quality, collaboration, and service. Our team of expert scientists will work with you to develop and optimize analytical testing methods for cell and gene therapy methods, products, and other elements of this growing field. Frontage Laboratories can provide help with all your method development, verification, and validation needs for cell and gene therapy testing.