This article reviews technology trends in antibody purification. Section 1 discusses non-
chromatography methods, including precipitation, liquid–liquid extraction, and high …

For drug products manufactured in mammalian cells, safety assurance practices are needed
during production to assure that the final medicinal product is safe from the potential risk of …

Demonstration of viral clearance is a critical step in assuring the safety of biotechnology
products. We generated a viral clearance database that contains product information, unit …

With the advancements in upstream technologies, the capacity for monoclonal antibody
(mAb) production has transformed from a few milligrams to grams per liter. These titers lead …

Viral contamination is a potential risk of using biotechnology products derived from
mammalian cell lines. Therefore, to provide assurance of the safety of these products …

Viruses still pose a significant threat to human and animal health worldwide. In the fight
against viral infections, high-purity viral stocks are needed for manufacture of safer vaccines …

Virus filtration provides robust removal of potential viral contaminants and is a critical step
during the manufacture of biotherapeutic products. However, recent studies have shown that …

Anion exchange (AEX) is a common downstream purification operation for biotechnology
products manufactured in cell culture such as therapeutic monoclonal antibodies (mAbs) …

Recent progress in mammalian cell culture process has resulted in significantly increased
product titers, but also a substantial increase in process-and product-related impurities. Due …

High throughput screening (HTS) of chromatography resins can accelerate downstream
process development by rapidly providing information on product and impurity partitioning …