LBG interviewed six executives at companies that are either sponsoring biosimilar candidates or are CDMOs that manufacture biosimilars to identify some challenges and understand how CDMOs are adapting to capture this portion of the biopharmaceutical market.
For a growing number of biopharmaceutical companies, the world is getting smaller. They are operating in smaller, more flexible facilities; servicing potentially smaller markets; and managing local products. Local manufacturers are looking for ways of doing standard processing less expensively without making changes that carry regulatory risk.
“Single Use Becoming an Established Tool: Vendors’ Attention to Users’ Requirements and Familiarity Are Driving Increased Implementation”, May 15, 2010 (Vol. 30, No. 10), GEN|Genetic Engineering & Biotechnology News
As single-use bioprocessing approaches its first decade, integration and standardization are on everyone’s short list of desirable features. Suppliers are responding with significant initiatives to streamline the specification, acquisition, assembly, and deployment of disposable equipment.
There are two major components in making new biologic medical countermeasures available for bio-defense and pandemic response: (1) the detection/discovery of effective countermeasures, and (2) their subsequent Process Development (PD) and manufacture. PD and manufacturing, however, are often the most costly and time-consuming parts of the process, potentially taking years and costing hundreds of millions to billions of dollars.
To address these long timelines, governments have historically stockpiled countermeasures for known biothreats. Unfortunately, this kind of stockpiling is very expensive, and does not provide protection against novel threats. Fortunately, there currently exist many new technologies that, when combined strategically, have the potential to significantly reduce the time and cost associated with the PD and manufacturing of biologic countermeasures.