Therapeutic biology encompasses different modalities, and their manufacturing processes
may be vastly different. However, there are many similarities that run across the different …

The aim of dryer scale-up is to increase batch size, or throughput of a continuous process,
while maintaining final moisture content, product quality, end-use properties, safety and …

Objective The purpose of this paper is to re-visit the design of three steps in the freeze-
drying process, namely freezing, primary drying, and secondary drying steps. Specifically …

The freezing step of the lyophilization process can impact nanoparticle stability due to
increased particle concentration in the freeze-concentrate. Controlled ice nucleation is a …

Research into the production of solid-state biomolecules has increased in the last decade,
uncovering new routes of administration and enhanced product stability. Freeze drying is the …

Scale-up and transfer of lyophilization processes remain very challenging tasks considering
the technical challenges and the high cost of the process itself. The challenges in scale-up …

The process of lyophilization plays a crucial part in the manufacturing of pharmaceutical,
biotechnology, and food industries products by enabling the production of stable medication …

During pharmaceutical lyophilization processes, inter-vial drying heterogeneity remains a
significant obstacle. Due to differences in heat and mass transfer based on vial position …

In this study, we present the lyophilization process development efforts for a vaccine
formulation aimed at optimizing the primary drying time (hence, the total cycle length) …

Primary drying is the most critical stage of the freeze-drying process. This work aimed to
establish a design space for this process by means of mathematical modeling of the primary …