Life Science Leader Magazine Supplements

CMO Leadership Awards 2013

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Pharma Manufacturing MANUFACTURING MODEL CONTINUOUS BATCH Make To Order (MTO) Make To Forecast (MTF) Make To Spec (MTSpec) Make To Stock (MTS) PRODUCT PORTFOLIO Biologics Branded Therapeutics Vaccines & Diagnostics Generics BATCH SIZE Low Volume, High Mix Variable Volume, Variable Mix Variable Volume, Low Mix High Volume, Low Mix LEAD TIME Short Medium Medium Long FINISHED GOODS No Yes Yes Yes ORDER FULFILLMENT SUPPLY CHAIN CONSIDERATION RESPONSIVENESS terns by SKUs and then defining the order fulfillment process for the finished goods. Further, upstream processes, such as raw material (RM) supply chain, procurement, and warehousing, can be decoupled and refined across the spectrum of push to pull to achieve an optimal supply chain model. This can be achieved by conducting a detailed mapping of the fulfillment process from formulation to quality control to packaging and distribution, with a focus on lead time at every node, minimum safety-stock requirements, impact of major events on inventory levels such as approval of drugs, total landed cost, and manufacturing constraints for each product portfolio. Further, the supply chain model can be optimized for resource, transportation, supplier contracts, cross-border delivery, and other criteria. ALIGNING MANUFACTURING WITH THE SUPPLY CHAIN PORTFOLIO TodayÕs pharmaceutical manufacturing functions largely as a disconnected business with little alignment with fulfillment models. The right supply chain model for a product or a portfolio of products depends on how well the supply meets the demand. With increased yield and efficiencies, lower capital and operating expenditure, less waste, and greater product recovery and economies of scale, continuous manufacturing is well suited for generics-based MTS or MTspec therapeutic agents. Continuous manufacturing offers an advantage in that capac56 The CMO Leadership Awards 2013 EFFICIENCY ity can be adjusted to market demand. Local manufacturing plants can be configured to reduce transportation and stocking to meet local demands. Various manufacturing sites disp ersed globally can be brought to the same level of quality standards. Product demand for generics can come from various sources, including online. Therefore, it is imperative that manufacturing be cost-efficient such that order fulfillment is always ready to meet any demand with a cost-effective push model. Biologics with an MTO fulfillment model are well-suited for batch processes where sales forecasts are unstable, the customer population is small, and product and manufacturing complexities are high. Batch processing enables careful considerations of product modifications, such as accurate posttranslational modifications, safety, quality, and downstream processing. For metabolite-based therapeutic agents, the batch process may be preferable due to strain degradation and stability issues that are often associated with continuous manufacturing technology. Recombinant DNA-based biologics are better produced using batch processes where optimal culture conditions are achieved for improved yields. Further, a fed-based culture system Ñ a hybrid system between continuous and batch processing Ñ can be adopted where quality, cost, order-to-delivery time, cycle time, and other factors can be easily controlled to align with a selected supply chain model. Evaluating manufacturing processes and aligning with the

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