Subvisible particulate matter is under increasing amounts of scrutiny in the field of parenteral and ophthalmic drug products. USP <1788> and <1788.3> explicitly recommend the use of flow imaging and ...

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 ...

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 ...

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