BioPharm International - February 2020

BioPharm-Outsourcing eBook

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12 BioPharm International eBook February 2020 Using the "Cubic Effect" to Drive Cell and Gene Therapy Commercialization Contract partners must help innovator biotechs consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost. T he cell and gene therapy industry is at a major inflection point, as therapies move out of clin- ical trials and into the commercial market. As more therapies are commercialized and become established, demand for cell and gene therapies will grow, leading to vast changes in patient care. Currently, dozens of products are already in Phase III, including second-generation cell and gene therapies such as CAR-T (chimeric antigen receptor T cells). Over the next 5–10 years, more than 70 cell and gene thera- pies are expected to be commercialized and available to patients. SMALL BIOTECHS LEAD THE WAY Small and virtual biotechs are driving innovation in this sector, and make up over 85% of cell and gene therapy developers. Without the infrastructure of larger pharma and biotech companies, these smaller inno- vators face unique challenges in manufacturing these advanced therapies and ultimately bringing them to the market (1). The question for the industry and the sciencephoto - ALBERTO SANTAGOSTINO is senior vice-president and head of cell and gene technologies at Lonza Pharma and Biotech ALBERTO SANTAGOSTINO Partnerships for Outsourcing Manufacturing

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