A revised version of the USP chapter on Subvisible Particulate Matter USP<1788> became official on 1 st May 2021. USP<1788> is meant to expand on the information given in the chapters <787>, <788> 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 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 ...