May 6-11, 2018
Therapeutic proteins, vaccines and – further away – cell and gene therapies are considered essential to find efficacious interventions and preventive measures to a rather long list of prioritized needs in healthcare. The challenge is developing into a ‘tsunami’ of sorts as the global demographic transition causes populations to age, dramatically accelerating the growth of non-communicable disease (NCD) in all parts of the world. India and China are the markets with the largest patient population for almost any NCD, or they are going to be in that position soon. Competition in this field is ramping up with an intensity that was previously unknown. Not only are there typically five to ten molecules from western originator companies for the same medical indication, but now there is finally also a huge wave of biosimilars entering the global markets. Asia is a hotspot in three ways: as the largest future market, as a location for manufacturing, and as an area with growing significance for the development of biologics. These developments all focus management teams onto financial performance of their businesses, namely via pricing of drugs and vaccines and cost of operations, not the least manufacturing cost. Different approaches to think about setting up manufacturing technologies such as continuous processing and incorporation of single-use equipment into routine large scale production are all part of this economic improvement discussion. Individualized therapies at the extreme for just one patient are an exciting medical route but process scientists and regulatory affairs must have nightmares over cost and approval challenges. Healthcare payers are already alarmed looking at annual treatment costs between $10’s to 100’s of thousands per patient with current therapies produced with the best of todays’ manufacturing tools. Regulators find proteins complex enough, cells must look like ‘mission impossible’ to them with today’s approaches. The discussion about future strategies and technical approaches goes far beyond the science and the engineering of bioprocesses. This presentation aims to describe the future scenario with its challenges, extract what was truly successful in the past, but then also de-mystify some of the hype topics in technology often considered as the holy grail of future manufacturing. Finally, there will be more questions than answers and these shall be the framework for this conference the ones to come.
Günter Jagschies, "Cell Culture Bioprocess Learnings: Past successes and future challenges" in "Cell Culture Engineering XVI", A. Robinson, PhD, Tulane University R. Venkat, PhD, MedImmune E. Schaefer, ScD, J&J Janssen Eds, ECI Symposium Series, (2018). http://dc.engconfintl.org/ccexvi/237