A steady increase of product titers and the corresponding change in impurity composition
represent a challenge for development and optimization of antibody production processes …

In manufacturing of biological drugs, product quality is defined by the process (eg
equipment, sequence of unit operations, operation parameters) because no complete …

Improvements in upstream production have boosted productivity in the biomanufacturing
industry, but this is leading to bottlenecks in downstream processing as current technology …

The demand for monoclonal antibody for therapeutic and diagnostic applications is rising
constantly which puts up a need to bring down the cost of its production. In this context it …

The concept of design space has been taking root as a foundation of inprocess control
strategies for biopharmaceutical manufacturing processes. During mapping of the process …

The biopharmaceutical industry is at a turning point moving toward a more customized and
patientoriented medicine (precision medicine). Straightforward routines such as the …

Rapid advances in intensifying upstream processes for biologics production have left
downstream processing as a bottleneck in the manufacturing scheme. Biomanufacturers are …

The rapid development of high-yielding and robust manufacturing processes for monoclonal
antibodies is an area of significant focus in the biopharmaceutical landscape. Advances in …

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 …

The realization of an endtoend integrated continuous labscale process for monoclonal
antibody manufacturing is described. For this, a continuous cultivation with filterbased cell …