The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations. Individuals working in pharmaceutical sterile ...

In-silico design facilitates process optimization and evaluation of process control strategies. The pharmaceutical industry has recognized the value of implementing a systematic approach to drug ...

Turning 3-dimensional product models into manufacturing process designs is no easy task. Kevin Marseilles, senior process designer with Delphi Corp.’s Saginaw Steering Systems Division, used to spend ...

Ska Fabricating reports that food manufacturers are automating processes to boost efficiency, ensure safety, and meet rising ...

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 ...

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Design for manufacturing (DFM) is the process of designing ...

Once upon a time, integrated circuits (ICs) were built by the same companies that designed them. The design of an IC was tightly integrated with the manufacturing processes available within each ...

Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in the ...

The need for Design for Manufacture and Assembly (DFMA) began shortly after the dawn of the Industrial Revolution, but it took a hundred years for it to ultimately come into focus in the 1960s, and it ...