Article | April 28, 2022

End-To-End Cell & Gene Therapy – From Development To Commercialization – Buy Or Build?

By Aldo Romano, VP of Commercial Development, and Emily Moran, Senior Director, Viral Vector Manufacturing

Pipette clean room laboratory cell and gene GettyImages-530817998

The exponential growth of the cell and gene therapy (CGT) market has been driven by the convergence of several economic and scientific developments. The rapid growth in computing power combined with the use of artificial intelligence has resulted in a greater understanding of the human genome and its role in the origin of disease. Scientists have now identified more than 6,000 life-threatening diseases that are the result of a single genetic defect.

The convergence of these technologies and computing power amplifies the transformative promise cell and gene therapies can offer to millions of patients. If manufacturing obstacles and capacity constraints can be resolved, the growth potential for these innovative and life-saving treatments can be achieved. The industry desperately requires development and manufacturing capacity to meet the growing demand.

In addition to the advances in innovation, other factors are driving the demand for manufacturing capacity, including both the macroeconomic and geopolitical environment. Venture capital, IPOs, and M&A volume in the life sciences are at all-time highs. Supply chain constraints experienced before and during the pandemic have led to the on-shoring of manufacturing supply. The pandemic has resulted in vaccine development that has led to extreme demand for manufacturing capacity.

The lack of process development and manufacturing capabilities within many of the companies developing these therapies represents another major challenge. Accelerated timelines put pressure on academic institutions, biotech start-ups, and pharma companies to decide early in the clinical process the best path forward to manufacture, and ultimately commercialize, their CGT product candidates. This decision is often referred to as the choice to “buy” – partnering with a Contract Development and Manufacturing Organization (CDMO) or to “build” – building the development and manufacturing capacity in-house. The latter can present significant financial and resource burdens.

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