Traditional manufacturing approaches and disruptive technologies compete for attention at BIO 2010
One common theme among many of the BIO main conference sessions was the continuing discontinuous technology shifts, such as the emergence of disposable processing technologies and the continued development of alternatives to the conventional microbial fermentation or mammalian cell culture methods used for producing today’s commercial biopharmaceutical products, which could transform our industry in the coming years. In a session chaired by BPTC President and Principal Consultant Howard Levine, such diverse technologies as cell-free protein synthesis and alternatives to traditional egg-base technologies for vaccine production were explored.
Of course most companies in our industry prefer a more conservative path so the prevalent approach to early stage CMC development continues to be the more traditional methods of production (CHO for antibodies, microbial fermentation for some smaller proteins, etc.). To access the entrenched industry knowledge and expertise or to accelerate the path to the clinic, many smaller companies turn to outsourcing for their development and manufacturing needs which enables them to secure clinical trial material within minimal capital investment and without hiring teams of development scientist and engineers. Accelerating drug development through outsourcing was addressed in a vidcast sponsored by BioPharm International, in which BPTC Vice President and Senior Consultant Susan Dana Jones provided advice on CMO selection and management. For successful tech transfer, “don’t throw the project over the fence and wait for results. It’s YOUR product and you need to manage the relationship with your CMO.” Susan also stressed that “it’s never too early to start thinking about your manufacturing strategy.” Howard Levine was also interviewed by Biopharm International editor Laura Bush in a vidcast on the state of the art of monoclonal antibody development. According to Howard, the cost of CMC development and manufacturing for an antibody prior to initiating Phase 1 clinical trials is in the range of $4 million and can take 12-18 months.