Lyophilization, also referred to as freeze-drying, is a complex process that removes water from the drug product to preserve the product’s chemical and physical integrity. In this blog, we will ...
Approximately one-third of the unique biologicals in the FDA’s purple book are lyophilized, according to a recent paper. That includes (in 2020) nearly a quarter of monoclonal antibodies. Trends ...
The increased demand for biopharmaceutical products is increasing the demand for lyophilization innovations and services. Parenteral drug development and manufacturing within the bio/pharma industry ...
Lyophilization is emerging as an effective way to prolong the shelf-life of biologics and to ease their refrigeration requirements, but its process development often requires multiple experiments.
Developing freeze-drying processes requires patience and deep product and process understanding. Messenger RNA (mRNA) molecules are inherently unstable and readily degrade when exposed to ubiquitous ...