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 ...

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 ...

Subvisible particles have the potential to impact efficacy, safety, and regulatory compliance throughout the field of biotherapeutics. Conventional particle analysis methods only provide particle ...

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 ...

In biotherapeutic development, hitting roadblocks due to insufficient developability assessment is a common and costly setback. Traditional particle analysis methods demand more sample volume than is ...

FlowCam uses Flow Imaging Microscopy (FIM) to characterize particles in liquid biopharmaceutical formulations. There are several important features of FIM instruments to keep in mind if you are ...

The United States Pharmacopeia (USP) and others, such as EP, JP, and ChP, have developed test techniques to ensure that particle counts are kept to a minimum in intravenous injections (parenteral ...