Cambridge Healthtech Institute:Inaugural Cell Therapy Bioproduction

The cell therapy industry is no longer a niche sector, but has grown into a significant and sustainable component of the global biopharmaceutical industry. Today, its prospects are strong with annual revenues over US$1 billion. As more and more cell therapy companies advance beyond phase 1 & 2 clinical trials, their focus begin to shift toward the challenges in the scale up and manufacture of these cell therapeutics.
The inherent nature of the cells makes manufacturing them a huge challenge. Not only are their MOAs not easily understood, the cells’ behavior in vitro are not indicative of their behavior in vivo. Coupled with the adherent nature of the cells and the difference between allogeneic and autologous cells which makes scaling up/out a big challenge, the industry is also faced with issues such as the lack of devices made especially for the cell therapy industry, resulting in companies having to adopt technologies made for biologics or the blood industry to be applied on cell therapies. Unclear regulatory guidelines and the lack of standardization as well as high COGS and subsequent reimbursement challenges further add to the hurdles for the industry.
CHI’s Cell Therapy Bioproduction conference offers a platform for you and your colleagues to come together to exchange ideas and solutions that will help resolve the challenges and bottlenecks in your development and manufacture of cell therapies, from cell culture, scale up, harvesting, to formulation, stability, delivery and cold chain management.