Tryptophan is one of the essential mammalian amino acids, and is thus a required
component in human nutrition, animal feeds, and cell culture media. However, this aromatic …

Large scale biopharmaceutical production of biologics relies on the overexpression of
foreign proteins by cells cultivated in stirred tank bioreactors. It is well recognized and …

Although process intensification by continuous operation has been successfully applied in
the chemical industry, the biopharmaceutical industry primarily uses fed-batch, rather than …

Controlling the charge profile of therapeutic protein is a critical challenge in the current
quality‐by‐design (QbD) paradigm, throughout all phases of biologics process development …

During biopharmaceutical process development, it is important to improve titer to reduce
drug manufacturing costs and to deliver comparable quality attributes of therapeutic …

Replacement of serum and increasing use of chemically defined media demands
optimisation of trace metal components for biomanufacturing applications. Trace metal …

Temperature shift (TS) to a hypothermic condition has been widely used during protein
production processes that use Chinese hamster ovary (CHO) cells. The effect of temperature …

Process changes are inevitable in the life cycle of recombinant monoclonal antibody
therapeutics. Products made using pre-and post-change processes are required to be …

To achieve the high protein concentrations required for subcutaneous administration of
biologic therapeutics, numerous manufacturing process challenges are often encountered …

Controlling acidic charge variants is critical for an industrial bioprocess due to the potential
impact on therapeutic efficacy and safety. Achieving a consistent charge variant profile at …