Aceto has been servicing the life science industry for more than 50 years. We supply a wide range of GMP grade excipients, intermediates and process solutions to gene & cell therapy manufacturers around the world. Our GMP raw materials are used in a variety of novel gene therapy products by some of the world’s leading biopharmaceutical companies.
We also provide GMP custom development of niche and novel excipients, GMP custom manufacturing, and GMP packaging & repacking of liquid and powder raw materials. At Aceto, we offer tailor-made GMP solutions for excipients and raw materials, from early-stage formulation development to late-stage commercial scale supply.
View our biopharma product portfolio HERE.
Gene therapy is a novel type of medicine where genetic material is introduced into cells to correct abnormal genes. Genes can be inserted in living human cells via various vehicles, also known as vectors, such as viral vectors, bacterial vectors or plasmid DNA. Functional genes are delivered to target cells in the human body to restore normal functioning of abnormal genes.
Cell therapy involves using modified cells to elicit therapeutic effect upon administration. Cells are modified to produce cytokines, chemokines or hormones to obtain desired medicinal effect in human bodies.
With significant number of candidates in development phase, it is imperative for cell and gene therapy manufacturers to use pharma grade material to ensure reproducibility of manufacturing processes and safety and efficacy of the end products.
How is Gene and Cell Therapy manufactured?
Gene and Cell therapy manufacturing can be broadly divided into three phases: upstream processing, in which vectors, therapeutic genes and therapeutic cells are produced; downstream processing, through which vectors, therapeutic genes and therapeutic cells are purified; and formulation processing, where vectors containing therapeutic genes and modified cells are formulated into a final injectable gene and cell therapy products.
Raw materials and excipients manufactured under full GMP compliance are essential to avoid carryover of impurities into the finished therapeutic goods and to ensure the materials won’t pose any risk to the safety and efficacy of the final gene and cell therapy products.