Analysis

Advanced biopharmaceutical manufacturing

An evolution underway

The global pharmaceutical portfolio of today reflects increased therapeutic competition, a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise of treatments for many orphan diseases. This need for high quality and readily available complex medicines is fueling innovation in biopharmaceutical manufacturing technologies, which in turn, is driving changes to the industry overall and providing potential benefits to society. The advances have motivated biopharma manufacturers to take strategic actions around manufacturing talent, collaborations, and location.

Biopharmaceutical manufacturing technology innovation

The changes in biopharmaceutical portfolios and the rise of advanced manufacturing technologies have impacts both inside and outside of biopharma companies. First, they are driving biopharma companies to seek increasingly specialized workers who possess needed experience and skills. As a result, organizations are helping to design training programs at university biomanufacturing centers devoted to teaching relevant skills to students and employees. Second, the changes are causing biopharma companies to work collaboratively on manufacturing innovation through partnerships with academic institutions, diagnostics developers, production equipment manufacturers, and medical device manufacturers. Third, the new portfolios and technologies required are giving biopharma companies more reasons to consider location and ecosystem advantages in their strategic decisions around manufacturing. Finally, the rise of biopharmaceutical advanced manufacturing technologies is positively impacting society by benefiting patients, the environment, and the nation’s standing as a leader in innovation — perhaps even enhancing overall U.S. competitiveness.

Potential impacts of biopharmaceutical manufacturing

Advanced biopharmaceutical manufacturing

The past decade has seen a significant shift in the nature of the products being manufactured and sold by the innovative biopharmaceutical (biopharma) industry. The global biopharmaceutical portfolio of today reflects increased therapeutic competition, a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise of treatments for many orphan diseases. These trends have given rise to biopharmaceutical products with extremely limited production runs, highly specific manufacturing requirements, and genotype-specific products. This fundamental shift in the overall product mix and a focus on continuing to improve the efficiency and effectiveness of production is spurring an evolution in the technologies and processes needed to support advanced biopharmaceutical manufacturing.

Innovation in manufacturing technology is helping to drive improved economics, flexibility and quality while potentially benefiting patients both directly and indirectly. Biopharmaceutical manufacturers are generally making investments in the following areas:

  • Continuous manufacturing to improve scalability and facilitate time to market, while lowering capital and operating costs and enhancing quality
  • New process analytical tools to improve process robustness, accelerate scale-up to commercial production and drive more efficient use of resources
  • Single-use systems to increase flexibility and reduce production lead times, while lowering capital investment and energy requirements
  • Alternative downstream processing techniques to improve yields while lowering costs, green chemistry to reduce waste, and new vaccine and therapy production methods to increase capacity, scalability, and flexibility.

Additionally, new types of products are coming to market that help increase the effectiveness of medicines and support patient compliance, such as products that reflect improvements in drug delivery systems and drug-device combination products. These products require advanced manufacturing techniques on the part of the biopharmaceutical company and its supply network, as the manufacturing process itself is becoming more central to the effectiveness of medicine.

To learn more, read the Advanced Biopharmaceutical Manufacturing report.

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