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Pharma Manufacturing THE SUPPLY CHAIN PORTFOLIO Biologics are characterized by low-volume, disease-defined small batch sizes, and shorter lead-time. The make-to-order (MTO) fulfillment model, along with demand-driven capacity planning, can be leveraged for manufacturing such therapeutic agents. Batch processes with single-use equipment can be adapted to biologics for niche markets where scalability is not a factor. Batch processing also makes it easy to switch production of one product to another, either for clinical trials or sustained manufacturing. Biologics are more amenable to a responsedriven fulfillment model that favors on-time delivery, personalized customer service, and flexible supplier contracts. Generic products, with their mix of high volume and low variety, can be fulfilled by leveraging make-to-stock (MTS) or make-toforecast (MTF), since batch sizes are large and products can be customized for a given market. Manufacturing follows smooth production with low-cost sourcing strategies. Demand forecast, product quality, asset utilization, and Lean manufacturing are key considerations to being more efficiencydriven than responsiveness-driven. On one end of the spectrum is the responsiveness-driven pull model; on the other end is the efficiency-driven push model. A product portfolio may not conform to one or the other supply chain model neatly, due to the nature of the products in a portfolio. For example, biologics will have subportfolios of products based on disease states, delivery mechanism, shelf life, and so forth. Although inventory reduction is ideal, the demand-based pull model is highly complex, and does not always lead to cost reduction in every situation. Degrees of agility, responsiveness, and efficiency trade-offs can be achieved further by applying supply chain strategies such as product postponement, vendor-managed inventory, and other supply chain network considerations where finished goods inventory (FGI) is not owned by the companies until they are shipped out to end customers. A small amount of safety stock is maintained at the regional distribution centers (RDCs) based on the replenishment lead time and variability of demand. Postponement strategies are specifically useful when local design and manufacturing are desired. Trade-offs between cost and responsiveness determine the best possible supply chain model. The keys to achieving excellence in pharmaceutical manufacturing and the supply chain are understanding the demand pat- The CMO Leadership Awards 2013 55