Freeze-drying is the most widespread method to preserve protein drugs and vaccines in a
dry form facilitating their storage and transportation without the laborious and expensive cold …

In the past two decades, biopharmaceuticals have been a breakthrough in improving the
quality of lives of patients with various cancers, autoimmune, genetic disorders etc. With the …

The ice-water interface is commonly encountered in our life, and comes into play in a wide
number of natural phenomena. Here, attention will be focused on its effects on protein …

Continuous manufacturing opens up new operation windows with improved product quality
in contrast to documented lot deviations in batch or fed-batch operations. A more …

The goal of this paper is to review the available process analytical technology tools for
monitoring the batch freeze-drying process for pharmaceuticals. These systems aim …

Lyophilization is a pivotal manufacturing process to obtain a stable drug product that is
unstable as a ready-to-use formulation. Some formulations may require the addition of drug …

Freeze-drying is the method of choice to dry formulations with biopharmaceutical drugs, to
enhance protein stability. This is usually done below the glass transition temperature of …

Biopharmaceuticals commonly require freezing to ensure the stability of the active
pharmaceutical ingredients (APIs). At commercial scale, freezing is typically carried out over …

Various biopharmaceutical products are distributed as freeze-dried formulations in vials.
Minimizing batch heterogeneity, which refers to the variability of relevant properties among …

The stochastic nature of ice nucleation presents a major challenge in freezing and freeze-
drying processes of biopharmaceuticals in vials. During freezing, nucleation events occur in …