Stem cells and other regenerative medicine products offer considerable benefits to patients as well as potential financial rewards for companies. At the same time, cell-based therapies present challenges to regulators because, in many cases, they involve withdrawing cells from a patient’s bone marrow, blood or adipose tissue, growing cells in vitro with minimal to extensive manipulation, and then administering in some form the expanded (and possibly modified) cells population back into the patient.
The newly developed G1-3 fermentation process makes use of short, straightforward fermentation regimes for optimized space time yield.
This webinar will review regulatory expectations in assessing the comparability of biosimilars through protein chemistry techniques and cell based bioassays. Key considerations for developing robust bioassays for biosimilar comparison will be presented.
A recent survey conducted by the Economist Intelligence Unit highlights the new products that the biopharma industry identifies as most disruptive to their growth strategies in the next five years. The findings raise a challenge to biopharma to go beyond barriers to bringing new products to market by presenting ways to overcome these hurdles and make novel therapies a reality.
Recruiting patients and retaining their participation in a clinical trial remain the biggest challenges faced by pharmaceutical companies when developing new medicines. For a patient, participation in a clinical trial can be stressful and burdensome, resulting in one in four patients dropping out of a clinical trial prior to completion. With sponsors facing tight-timelines, increased regulatory scrutiny and spiralling budgets the desire to address these challenges has never been more prominent.