The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.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

Quality by design is critical for cell and gene therapy manufacturing where process controls directly influence product ...

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 ...

Modular dies significantly reduce initial capital costs by lowering material and machining expenses. Quick-change inserts enable rapid changeovers, decreasing downtime and increasing overall equipment ...

Posts from this topic will be added to your daily email digest and your homepage feed. Tesla is close to implementing a new die-cast process that could significantly reduce costs and simplify vehicle ...