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 ...

Recent advances in subcutaneous delivery methods now enable patient self-delivery of monoclonal antibody (mAb) therapies. Subcutaneous therapies often require concentrations around 100 to 200 mg/mL.

Top left shows how the in vitro aggregation of the protein TDP-43 (associated with ALS), seen as white blobs, is dependent on the concentration of ATP (measured in millimolar, mM). The same is shown ...

Nearly half of all drug shortages in 2022 were caused by quality issues or manufacturing delays, according to the Center for Drug Evaluation and Research (CDER). Evaluating the critical quality ...

Stability is one of the main quality characteristics in formulation studies of prospective therapeutic biomolecules. Researchers depend on high-throughput screening techniques to reduce the funds, ...

Siddhant Sojitra, Alexion, defines in an AAPS PharmSci 360 2025 presentation an agitation model to reliably test stability for early-stage biologics. Mechanical stress testing is essential because ...