Process Capability and Production Scenarios

This chapter provides an overview of typical scenarios for product-development phases, market needs for biopharmaceuticals and some features of available technologies relevant to process capabilities. Any production scenario depends on the capability of the process to deliver product of the required quality in the quantity needed for the purpose at each moment in the life cycle of the product. A typical statement of a production manager might be: ‘Process capability refers to the ability to produce the required quantity of the product. In more routine production with repeatedly large numbers of batches per product and long campaigns, additional development time can be afforded. Some of the advantages of flexibility and disposable operation disappear and are being replaced by—in those situations—lower cost fixed installations and re-use concepts. Process development needs to select methods that are feasible for these scenarios and should avoid forcing a change of concept between development phases, e.g. the use of a technology or product only available in disposable format while still in early-stage development. Cleaning and sanitization methodology needs to be developed. Biotherapeutic manufacturing processes with high annual production requirements generally require thorough optimization of all aspects that impact process economy. Monoclonal antibody and insulin production are the main examples for in today's biopharmaceuticals market.