Rossana GarcÃa
Gradocell, Spain
Title: Production of advanced therapy products: Scale up to industry processes?
Biography
Biography: Rossana GarcÃa
Abstract
Development of advanced therapies medicinal products represent a major challenge for companies or institutions who choose to manufacture and promote this type of medicines. ATMPs production requires a deep understanding of GMP, as well as a strong technical qualification. Facilities and equipment are unusual compared to the manufacture of conventional drugs, which increases the manufacturing complexity. From the viewpoint of quality control, analysis techniques are not very robust and some of them very complex. However, these medicines have become in the last 10 years in a hopeful alternative for some incurable diseases. This has led to extensive development of medicinal products for Gene and Cell Therapy for many indications, having conducted numerous clinical trials with these therapies. Currently, most of these therapies are experimental, with good safety and promising signs of efficacy. Only four products are approved by regulatory agencies and marketing stage, although it is estimated that in the coming years to increase the number of registrations of new ATMPs.
