The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.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

Design for manufacturing (DFM) is the process of designing your product with the goal of making it easy to manufacture. It is a critical manufacturing tooling design and process development step ...

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance. The quality-by-design (QbD) initiative, which focuses on building ...

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 ...

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 ...

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 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 ...

The Department of Engineering Design and Manufacturing is involved in a variety of research and training activities. The following is an overview of the areas that research teams work in, with some ...

For decades there have been five basic types of manufacturing processes. They are distinct. Great design engineers understand the nuances of these processes and tailor their designs accordingly. There ...

Virtual technology has existed for more than 50 years. However, augmented reality (AR) and virtual reality (VR) have only ...