[Whitepaper] The Right Partner Can Improve Flexibility and Mitigate Risks from Forecast Inaccuracy in Biomanufacturing
ORC International’s report “Implications of Inaccurate Forecasting on Biologics Drug Substance Manufacturing” explores the causes, consequences, and potential solutions to forecasting challenges specifically related to biopharmaceutical drug substance manufacturing.
Given the risks (and opportunities) inherent in drug development, choosing the right forecasting and manufacturing strategy to sufficiently mitigate risks while remaining flexible enough to take full advantage of opportunities, such as expanded clinical indications, when they arise presents a major and significant challenge to companies developing and commercializing biopharmaceutical products. Overall, the ORC report and BPTC acknowledge that demand for biopharmaceutical products will continue to grow over the next several years, and biomanufacturing capacity will likely become constrained as this demand continues to increase. To ensure product companies have access to the right capacity and to ensure CDMOs can offer the right capacity, all parties must work closely together to improve forecasting accuracy over the next several years. In light of the rapid growth of development of biopharmaceutical products, regulatory changes, and tightening capacity access, choosing partners who can offer greater flexibility to respond to inevitable changes in demand is among the best strategies to mitigate risk.