(144g) Quality be Design and Regulatory Science: An Academic Perspective

.           In advanced biomedical manufacturing, Quality System Regulation (QSR) has already been used by CDRH in medical device regulations and oversight since 1997 while Quality By Design (QbD) initiative by FDA has recently been adopted in pharmaceutical and biopharmaceutical sectors. FDA defines QbD as doing the science to design process performance characteristics, not merely empirically derived from the performance of traditional test batches. The specific challenge in QbD has been on how to obtain essential scientific understanding of intrinsic cause-effect relationships between process and products for improving process control and reducing products risk and eventually reaching the desired state of potential real time product release of any biomedical product with minimal final quality testing. The slow adoption of QbD can partly be traced to our current life science science and engineering research, education and training. Many academic research groups have been investigating unique and challenging biomedical products and technologies through advances in genomic and biomedical research. Often, the potential product candidates coming out from the lab are very complex in nature that are often ill defined and require custom-designed formulations, distribution and delivery that post challenging scale-up and other technical and regulatory issues. Unfortunately, there is nearly a complete absence of any focus on manufacturing science related efforts that emphasize design and quality controls, data reproducibility and information traceability. This is surprising, given that reliable and cost effective manufacturing of biomedical products and devices have been identified to be a major roadblock for many innovative biomedical solutions. We shall discuss these roadblocks and advocate some possible solutions to remedy this obvious deficiency.