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.
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