If You Build It, Will They Come? The Promise and Perils of Investing in Biomanufacturing Capacity
With the increasing likelihood that health-care reform in the US will include a biosimilars regulatory pathway, there is increasing interest from a wide range of companies in the biosimilars market. Any new entrant into the biosimilars market will need to develop a biopharmaceutical manufacturing strategy to support their intended pipeline. The complexities of manufacturing biologic products make this requirement daunting for those with no experience in biopharma manufacturing. This presentation provides an overview of the industry-wide landscape for biomanufacturing capacity and the trends in this area, including rising productivity of biopharma processes leading to lower capacity utilization, and increasing use of disposable-format (or single use) technologies. The impact of these trends on biosimlars manufacturers is also reviewed.