RoSS® Shell | Protecting Single-Use Bags
Precision Fluid Management for ADCs
The hidden gaps in the fill-to-freeze workflows
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Most bulk drug substances are filled into 2D single-use bags for one reason: they are about to be frozen. Yet filling and freezing are often treated as separate unit operations. Filling systems are selected for accuracy and throughput. Freeze-thaw...
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...
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...
The current Good Manufacturing Practice (cGMP) regulations - originated and checked by the FDA - apply to companies operating in pharmaceutical, biotech, or med tech industries. They require the latest standards in terms of production, manufac...
The fact that the pharmaceutical manufacturing process, including pharmaceutical fermentation, is still prone to human error and product loss can be more than frustrating. This is even more true when dealing with issues that are near and dear to y...
While the original definition of fermentation is ‘the anaerobic conversion of sugar to carbon dioxide and alcohol by yeast”, fermentation in the pharmaceutical industry is used to cultivate microorganisms for antibiotics, therapeutic proteins, enz...
The manufacturing process of biopharmaceuticals such as monoclonal antibodies, mRNA and bioconjugates is divided into upstream and downstream processing. Manufacturers seeking reliable automation and optimization fit for scale-up are increasing...
One would think that a sector like the fast-paced biomanufacturing industry could not get any faster. Yet, increased speed-to-market and ever more efficient manufacturing continue to drive product and process development. This is why single-use...
Upstream and downstream processing are two steps inherent to the production of active pharmaceutical ingredients (API) used in biopharmaceuticals. Upstream processing takes small quantities of engineered microbial or mammalian cell culture to g...
[[ToC]] When to apply cryogenic freezing? Cryogenic freezing is a necessary process for the preservation of molecules, cells, genetic material, blood, and tissues. Single-use technologies enable protection of such substances from contamination and...
The evolution of single-use technologies (SUTs) is among the most important developments of biomanufacturing. Large stainless-steel containers have long been used for storage and cooling of drug substances. However, there has been a shift toward S...
Single-use bioprocessing has recently experienced tremendous growth in biopharmaceutical manufacturing market share and enjoyed technological advances ranging from material properties, to implementation of Industry 4.0. In contrast to traditional ...
