In order to ensure American soldiers fighting in remote locations overseas can receive the biopharmaceuticals they need on time, Defense Advanced Research Projects Agency (DARPA) created a program called Biologically-derived Medicines on Demand (Bio-MOD). The goal of Bio-MOD is to build a system that has the ability to create an on-demand biopharmaceutical in less than 24 hours. I spoke with one of the teams working on this effort about how they intend to accomplish this and what it could mean to the future of the industry.
Clinical outsourcing is constantly changing as a drug companies seek new ways of working faster, leaner, and to higher standards. This is causing sponsors to reexamine different outsourcing models and challenge traditional approaches such as, traditional outsourcing, full-service models, or Functional Outsourcing (FSP) models.
Technological advances in genetic engineering particularly expression systems (the genetically modified cells that express desired proteins), process design, and equipment continue to be combined such that the same amount of drug product can be manufactured at a much smaller scale. According to the Biopharmaceutical Manufacturing Capacity and Production Survey revealed an overall increase in productivity and efficiency in biomanufacturing.
Where are CMOs investing in new technologies that will improve bioprocessing today and over the next five years?
The path from molecule to market isn't getting any easier. The costs of drug development continue to rise. A change needs to be made. While outsourcing is nothing new, there are new strategies for pharmaceutical companies to consider. CDMOs with the right skills and mindset now have the ability to streamline and accelerate development and manufacturing.
The complexity of today’s molecules and the growing majority of new molecule development are calling for a new method of drug production. Biopharma companies of all sizes are looking to vendors to manage development, manufacturing, and capacity needs. The question is: Are they keeping up?
In the dynamic contract development and manufacturing organization (CDMO) industry, client-focused businesses succeed in retaining and growing our client base by delivering on project objectives and satisfying a client’s expectations.