Protein-based therapeutics have transformed treatments for numerous diseases, yet their production remains highly complex and cost-intensive [1][2],[3][4]. Downstream processing (DSP), including ...

Biotherapeutics continue to revolutionize how clinicians treat many human diseases. Protein therapies using molecules like peptides and monoclonal antibodies have become well established in the clinic ...

Regulators question whether particles that they can't see hurt patients. Protein aggregates in biological drugs have the potential to trigger an immune response in the patient, which, at the very ...

Subvisible particulate testing is critical to assess the safety of medical devices, and particulate contamination should be minimized to avoid possible negative health consequences to the patient. A ...

Flow imaging microscopy can be used to identify particulates and their sources. Subvisible particles (SVP) are a concern for biologic-based drugs. Some technologies can detect but not identify ...

Subvisible particle analysis is a key predictor of protein drug stability and a key formulation, quality metric. However, current methods use large volumes of precious protein solutions and are labor- ...

Emerging biologics such as multispecific antibodies, mRNA vaccines, and viral vector–based gene therapies are more complex than established biologics such as monoclonal antibodies and recombinant ...

This educational session will focus on some of the new demands in counting particles in liquids, with a focus on the challenges of preparing and sampling protein-based materials. USP has recently ...

In order to quantify the count and size of subvisible particles in eye care products, the USP <789> test is carried out. This consists of utilizing a light obscuration particle counter and counting ...

Subvisible particulate testing is critical to assess the safety of medical devices, and particulate contamination should be minimized to avoid possible negative health consequences to the patient. A ...