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 ...

Continuous pharmaceutical manufacturing represents a significant shift from traditional batch processing, integrating continuous flow methods, advanced process analytical technology (PAT) and ...

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 ...

Continuous manufacturing offers advantages in both biotherapeutic and API manufacturing but still poses challenges. The forward movement of the bio/pharmaceutical industry is driven by fast-paced ...

Imagine a future where rare diseases and devastating cancers can be swiftly treated with therapies produced directly in the clinic and tailored to a patient’s unique genetic profile. Common conditions ...

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 biopharmaceutical industry has seen substantial growth in recent years, generating novel biotherapeutics and biosimilars at an unprecedented rate. One of the biggest challenges in the industry is ...

Technological innovations throughout the past several decades have transformed the pharmaceutical manufacturing process from traditional batch production to ...

In recent years, fed-batch biomanufacturing has begun giving way to continuous manufacturing processes, as developers face pressure to balance affordability with high manufacturing quality. Although ...