Protein biopharmaceutical products are being developed in large numbers for a wide variety of indications. Even with the inevitable attrition through the development and regulatory process, many new products will eventually receive marketing authorisation and require manufacturing capacity to come to market. Earlier in the history of protein biopharmaceuticals, there were relatively few products, each had a significant market size, and their novelty sustained high prices. Now, many products are being developed that have relatively smaller markets and cannot sustain the current unit price levels.To accommodate this evolution in the protein biopharmaceutical industry, manufacturing facilities, processes, and regulatory compliance need to shift to allow lower annual product volumes, multi-product facilities, and high manufacturing efficiencies. As the biopharmaceutical market matures, price pressure will increase from both competition in the biosimilars market and from the unwillingness of purchasing organisations to sustain current high product prices.Traditional cost cutting measures - such as workforce and maintenance reductions - have uniformly led to severe reprimand and are simply not acceptable in today's regulatory environment.Through the use of advanced manufacturing technologies, it is possible to significantly reduce production costs, maintain high regulatory standards, and provide multiple low-volume, lower cost, products from a single manufacturing facility.
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