Freezing drug substances to ultra-cold temperatures is a standard step in biopharmaceutical manufacturing. Yet, beyond simply cooling, it’s the critical quality attributes (CQA), like product safety, consistency, and process efficiency, that trul...
The global distribution of pharmaceuticals is complex and demanding, requiring precise handling and storage of sensitive products. With the rise of personalized medicine and the increasing globalization of the industry, the need for safe and effic...
The filtration and filling of drug substances, if not done correctly, can cause severe problems. If the production steps in drug substance management from compounding to filling, labeling and dispensing of a drug substance leaves space for cont...
Microbial fermentation is a powerful, flexible microbiology process used to generate microbial cells or biomass such as proteins and enzymes for the production of vaccines and therapeutics. Consequently, fermentation technology is a rapidly growin...
Microbial fermentation manufacturing is an effective method for the production of APIs, bioconjugates and smaller biologicals that play an important role in biotechnology and the production of biopharmaceuticals. Still, the fermentation process co...
Pharmaceutical packaging is becoming an increasingly important topic in the pharmaceutical industry, with the rise of biopharmaceuticals being a key driver of growth in this area. As the use of biopharmaceuticals continues to increase, so does the...
Microbial and bacterial fermentation is of great importance in the production of biologics, especially for the manufacturing of small molecules. The filling and freezing of large volumes for fermentation is an essential part during different produ...
Throughout the manufacturing process of drug substances, the liquids must be transferred frequently, such as during the upstream and downstream processing. Safe packaging of large volume substances is of high necessity in each step. Protection is ...
Pharmaceutical fermentation is a multi-stage process that not only facilitates high-cell density, but also a high yield in terms of final culture generation. Whether the final product requires microbial fermentation or the fermentation of mammalia...
Precision fermentation uses microbial hosts to produce a particular end product. Other terms used for precision fermentation are bacterial and microbial fermentation. Precision fermentation is used in a variety of ways in both the food industry an...
While one of the main goals of bulk drug substance management is to ensure quality control, safety during manufacturing, storage and transportation are of great importance. Nevertheless, the safe handling of bulk drug substances is a necessary ...
Microbial fermentation refers to the production of microbial products, which can be enzymes, vaccines or other drugs, by the use of microorganisms. For this process, compliance with cGMP (Current Good Manufacturing Practice,) and the FDA’s regulat...
Thawing drug substances or active pharmaceutical ingredients as they are also known is a routine biotech process in practically every drug product manufacturing campaign. Freezing and thawing biologics are considered necessary process steps to ...
