Senior Manager, Regulatory Affairs
GMP Ancillary Materials for Cell and Gene Therapy Manufacturing
Ancillary materials (AMs), also called raw materials in Europe, are components, reagents, and materials used in the manufacturing of cell, gene, and tissue-engineered (CGT) therapies but are not intended to be present in the final product formulation.
A Successful Journey to Cell Therapy Manufacturing: From Research and Development to Lot-Release
Cell therapy is a transformative cancer treatment that utilizes genetically modified cells from a healthy donor or patient's own immune system to attack cancer cells, but manufacturing these cells represents a major challenge for the industry.