Single-use technologies have transformed conventional biopharmaceutical manufacturing,
and their adoption is increasing rapidly for emerging applications like antibody–drug …

Cell therapies are emerging as a promising new therapeutic modality in medicine,
generating effective treatments for previously incurable diseases. Clinical success of cell …

Bone regenerative medicine is a clinical approach combining live osteoblast progenitors,
such as mesenchymal stromal cells (MSCs), with a biocompatible scaffold that can integrate …

Biologics may be subjected to various destabilizing conditions during manufacturing,
transportation, storage, and use. Therefore, biologics must be appropriately formulated to …

Innovative formulation technologies can play a crucial role in transforming a novel molecule
to a medicine that significantly enhances patients' lives. Improved mechanistic …

Degradation of polysorbates in biopharmaceutical formulations can induce the formation of
sub-visible particles (SvPs) in the form of free-fatty acids (FFAs) and potentially protein …

The introduction of new therapeutics requires validation of Good Manufacturing Practice
(GMP)-grade manufacturing including suitable quality controls. This is challenging for …

Background aims Advanced therapy medicinal products (ATMPs) are novel drugs based on
genes, cells or tissues developed to treat many different diseases. Stability studies of each …

Cell-based medicinal products (CBMPs) offer ground-breaking opportunities to treat
diseases with limited or no therapeutic options. However, the intrinsic complexity of CBMPs …

Standard freezing protocols of clinically relevant cell lines commonly employ agents such as
fetal bovine serum and dimethyl sulfoxide, which are a potential concern from both a …