12 BioPharm International eBook February 2020 www.biopharminternational.com
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
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Stock.adobe.com
ALBERTO SANTAGOSTINO is senior vice-president and head of cell and gene
technologies at Lonza Pharma and Biotech
ALBERTO SANTAGOSTINO
Partnerships for Outsourcing Manufacturing