The antibiotic cefazolin is an essential drug according to the World Health Organization (WHO). It is usually produced via batch manufacturing, but this multistep process is time-consuming, wasteful ...
Aim: To demonstrate the potential of in-line nanoparticle size measurements using the NanoFlowSizer (NFS) as a PAT method. To achieve real-time process control by establishing automated regulation of ...
Although continuous flow chemistry—wherein molecules are made in a continuous process rather than in batches—has gained ground in academic labs, its adoption by industry and contract manufacturing ...
People have recognized the promise of continuous manufacturing processes ever since Henry Ford’s auto assembly line kicked into action. Even so, pharmaceuticals are still made in batches. Proponents ...
Pharma and advanced therapy manufacturing will only grow more complex in science, regulation, and global scale. But the ...
Continuous manufacturing and a quality-by-design development approach are a natural fit. FDA, as well as other regulatory agencies around the world, have for many years been encouraging drug makers to ...
The size and size distribution of nanomedicines in various (bio)pharmaceutical products, including liposomes, lipid nanoparticles, recombinant proteins, and antibodies, plays a significant role in ...
Most facilities that fail in lean implementations have weak quality systems. More specifically, they have failed to create stable process flow. If you have some or even one of these issues, you will ...