The past decade has seen unparalleled growth in the field of cell therapy, which uses cells as therapeutic agents to treat and cure disease. Although the first transplants of blood stem cells date ...

Bioprocessing emerged from a history of extensive testing for quality assurance, but some of that is changing. Instead of an industry built on quality by testing (QbT), bioprocessing would benefit ...

In the past 10 years, the pharmaceutical industry has been moving towards a design space approach to development and manufacture – an approach that has been defined by ICHQ8, Q9 and Q10, and the ...

The biotechnology and pharmaceutical industries must adapt to new advancements to develop new therapies for patients with unmet needs. In this exciting time, there are a range of advanced modalities ...

Luxury or necessity for developing the best biologicals? “There is the perception in biopharm companies that it is too expensive and takes too much time to implement full QbD (Quality by Design) for ...

Continuous manufacturing and a quality-by-design development approach are a natural fit. FDA, as well as other regulatory agencies around the world, have for many years been encouraging drug makers to ...

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can ...

The S&P SmallCap 600 underperformed the Russell 2000 by 9% YTD, putting it on track to record its worst year of relative performance since its launch in October 1994. The S&P SmallCap 600’s relative ...

QbD is an industry initiative supported by regulators. However, it is also a systematic method of process development which delivers consistency, robustness and increased process knowledge. This ...