Cell & Gene Therapy Supply Chain: Early Preparation Is Key

By Matthew Farabaugh, Chief Financial Officer, The Center for Breakthrough Medicines

The promise of cell and gene therapy is no longer conceptual. The FDA has already approved biologics like Kymriah, Yescarta, Zolgensma and Luxturna. The fundamental pathway has been laid out by pioneers of these new advanced therapies. Consequently, there are many new biotechs and pharma companies in the space resulting in increased demand for cell and gene therapy supplies.

The complexity of cell and gene therapy development and manufacturing is unique compared to small molecule production. Consequently, supply chain management for these therapies requires precise demand planning and forecasting, especially with regards to long lead times. Further adding to this complexity is an “inch worm” effect where suppliers must catch-up with demand and increase their own manufacturing capacity for the raw materials required in complex cell and gene therapy global manufacturing facilities.