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 ...

Halo Labs is an innovator in drug product characterization and subvisible particle analysis providing unprecedented product quality insights to improve patient safety. Starting with the launch of its ...

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 ...

An update to USP<1788> Methods for Determination of Subvisible Particulate Matter was released in May 2021. Its goal is to assist in the support and clarification of the information provided in ...