This article proposes a “design space” structure for using Quality by Design (QbD) to develop processes and control strategies for developing and manufacturing biopharmaceuticals…
Tag: <span>regulatory guidelines</span>
The cell therapy industry is positioned to make major changes in healthcare and disease treatment. The Alliance for Regenerative Medicine (ARM) recently reported on the robust state of the industry and identified that revenue from cell therapy products grew from $460 million in 2010 to $1.3 billion in 2013. There are currently more than 40 commercially available cell therapy products with indications ranging from cardiovascular to cancer and non-healing wounds. The pipeline for these therapies is also expanding. ARM reports nearly 270 trials underway (Phase 1 through Phase 3). Another 58 projects are in the research stage and 245 in pre-clinical. Adding to this total, there are 77 industry-sponsored cell-based immunotherapy trials. Cell therapy represents a very different approach to treatment when compared to small molecules or many biologics. As such, regulatory authorities are evolving and adapting their approach to help ensure patient safety and efficacy of these innovative and complex therapeutics. A recent decision by regulatory authorities in Japan allows for an accelerated pathway for approval. This presents a tremendous opportunity for the industry, but at the same time, exerts tremendous pressure on developers to rapidly and efficiently characterize their products and processes in order to take advantage of such accelerated pathways. This article provides an overview of current regulations for cell-based therapies in the United States (US), European Union (EU), and Japan, and considerations for working successfully within these frameworks. It also describes a structured approach to process development that can help achieve accelerated timelines…