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 …

The success of biotherapeutic development heavily relies on establishing robust production
platforms. During the manufacturing process, the protein is exposed to multiple stress …

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 …

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 …

Pressure-dependent breakthrough of nanobioparticles in filtration was observed and it was
related to depend on both convective forces due to flow and diffusion as a result of Brownian …

The feasibility of using nanocellulose-based mille-feuille filter paper for upstream
applications in serum-free growth media filtration, ie Dulbecco's modified Eagle's medium …

To ensure the viral safety of protein therapeutics made in mammalian cells, purification
processes include dedicated viral clearance steps to remove or inactivate adventitious and …

Virus retentive filters are a key product safety measure for biopharmaceuticals. A simplistic
perception is that they function solely based on a size‐based particle removal mechanism of …

Controlling viral contamination is an important issue in the process development of
monoclonal antibodies (MAbs) produced from mammalian cell lines. Virus filtration (VF) has …

Pore-size distribution (PSD) is the most critical parameter for size-exclusion virus removal
filters. Yet, different dry-and wet-state porometry methods yield different pore-size values …