The choice of manufacturing strategy for cell-based therapeutics is one that is best made early in product development. Expense and delay may result from any additional bridging studies following changes to manufacturing process design late in development. The chosen strategy will be strongly influenced in turn by the preferred business model. Business models may favor either centralized or distributed manufacture. There are advantages and disadvantages to each and variants may be suitable in certain circumstances. An appropriate choice depends upon a combination of regulatory, economic and supply-chain factors. In this article the factors are examined and described in the context of hypothetical examples. In general the degree of decentralization will depend on a balance of manufacturing features. The investment risk of building a centralized facility at the projected capacity, the cost of managing quality and the cost or quality implications of long-distance cold supply chains must be considered. No single business model will suit all cases. For any innovation the decision must be based on an operational analysis at the projected capacity required.
Submitted for review: Dec 1 2015 Published: Mar 21 2016
DOI: 10.18609.cgti.2016.012; Citation: Cell Gene Therapy Insights 2016; 2(1), 95-109