The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.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

Building mechanical constraints into design decisions ensures smooth transition from prototype to production without ...

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 ...

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 ...

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 ...

The Fast Company Executive Board is a private, fee-based network of influential leaders, experts, executives, and entrepreneurs who share their insights with our audience. BY Sviat Dulianinov The AI ...

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 ...