The Process Map To Ensure Biopharma Raw Materials Supply
In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.
WHITE PAPERS & CASE STUDIES
High Concentration Monoclonal Antibody Drugs Manufacturing Challenges
A review of high-conentration mAb manufacturing challenges including viscosity, aggregation, instability, and the effect of excipients on formulation, filtration, and fill and finish and bioavailability.
Agglomerate-Free Dispersion For Hand Sanitizers
Obtaining an agglomerate-free dispersion is essential to ensure a clear, bright gel after neutralization but low density powders such as Carbopol can be difficult to incorporate into liquids with a conventional agitator. The high shear mixing of a Silverson mixer ensures rapid incorporation and dispersion of powders to form an agglomerate-free solution, with minimized aeration.