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...
[[ToC]] Shedding UV light on single-use bags The biopharmaceutical manufacturing sector is undergoing rapid transformation, with single-use technology becoming a fundamental aspect of efficient and safe production. Among the various components ...
[[ToC]] Unlocking potential with single-use bags: From outdated CryoVessels to state-of-the-art plate freezers The freezing method with multi-use cryogenic containers, also called cryovessels, has been used for decades. The open stainless-steel co...
Pre-use post-sterilization integrity testing (PUPSIT) is a crucial step in ensuring the integrity of sterilizing filters used in the biopharmaceutical industry. It is performed to verify a filter’s integrity after it has been installed and sterili...
Khalil Essani, Product Line Manager at Single Use Support, is an expert in bioprocessing applications for single-use technologies. He provides valuable insights, advantages and solutions using cell banking in seed train intensification in the f...
Ensuring the integrity of filtration processes is fundamental for the safety of bioprocessing. Among the array of methods available for assessing filter integrity, the bubble point test emerges as one of the most frequently used techniques. By scr...
Microbial and mammalian cell fermentation are important processes in the development of media and drug development for the production of biologics, most importantly vaccines. However, there are certain characteristics that differentiate them from ...
Filter integrity tests are essential in ensuring the reliability of biopharmaceutical processes – a stringent field governed by regulatory requirements such as those set forth by the FDA and GMP standards. These tests are critical components in up...
EU GMP Annex 1 basically treats pre‑use post‑sterilization integrity testing (PUPSIT) as a set of regulations to make sure sterilizing‑grade filters are still in perfect shape after they’ve been sterilized and before product use. If a manufacturer...
The demand for disposable bags is influenced by key industry players who acknowledge the market's requirement for dependable safeguarding of crucial and high-value goods within the biopharmaceutical sector. This includes intermediates as well as f...
Speed to market, flexibility, and process efficiency are more important than ever in biopharmaceutical production. Single-use systems support novel approaches to aseptic fluid management and aseptic liquid transfer. However, regarding the sustaina...
Aseptic filling represents a fundamental process within pharmaceutical manufacturing, serving to preserve the potency and safety of biologics throughout the production process. With stringent standards issued by regulatory authorities like the FDA...
Aseptic filling machines stand as the cornerstone in the filling of drug substance, ensuring the impeccable handling and packaging of delicate drug substances. These machines aren't just assembly line fixtures; they're the heartbeat of pharmaceuti...
