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 ...

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 ...