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 ...

In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using two-level factorial design. In the ...

Only gather the data you need, not the data you can, says a bioprocessing expert. Data is the foundation of biopharmaceutical manufacturing. The only way to understand if a production process is ...

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 ...

As the industry is moving towards applying Quality by Design (QbD) to process development, the question must be asked: Is this also the way forward to revolutionise, improve and standardise our ...

As part of the Food and Drug Administration’s current good manufacturing practice (cGMP), pharmaceutical companies must ensure the quality of drugs right down to the safety of the raw materials. That ...