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...
Name one biopharmaceutical manufacturing company which does not need containers for storage, transportation and transfer of hundreds of litres of liquids in 3D single-use bags. Is there even one? Biopharma totes are functional supporting devices t...
In recent years cell and gene therapies (CGT) have proven to be promising approaches to personalized medicine. Patients needing a cell and gene therapy as an advanced therapy medicinal product (ATMP) rely on their treatment being ready as soon ...
It's no secret that pharmaceutical substances are of high value in most cases. Even a small defect rate of biologics or ATMPs causes high financial losses. It is therefore of great importance to establish solid process logistics around freezing, t...
The quick and efficient aseptic filling transfer of highly valuable and at the same time extremely sensitive drug substances is a critical process step. While in the past pharmaceutical and especially biopharmaceutical manufacturers have relied...
Infiltrating product solutions from life science companies or any other supplier into Biopharma environment is justifiably not so simple. It is the primary goal to avoid contamination and insterility in clean rooms. One of these approaches to infi...
Customers sometimes see their new platforms the first time when they arrive at their manufacturing site. This can be a long time after they have decided to purchase new equipment for their manufacturing facilities. During FAT (factory acceptanc...
Suppliers for freeze thaw platforms are highly requested, as players in the biopharmaceutical industry are dealing with a variety of highly valuable and very sensitive goods. And in order to preserve their properties, bulk drug substances are c...
Reducing human errors is crucial in drug substance management, as they can be fatal and costly mistakes, even more so when they happen to employees in the medical and/or pharmaceutical fields. However, it is not only different types of human error...
The industry is about to acknowledge that sustainability is a mutual long-term goal where many parties are involved. All contributions and initiatives to make the industry even more environmentally friendly are a good step to make both the industr...
[[ToC]] How x-ray views affirm plate-based freezers as spearheaded freezing technology in Biopharma One of the most critical process steps for biopharmaceuticals is freezing the product in single use bags to sub-zero. No matter if companies are fr...
Without a doubt automated filling drug substance into single use bags will be the future in Biomanufacturing industry due to its efficiency and its approach towards sterility. However, single use assemblies for automated filling platforms lack fle...
With factory acceptance test (FAT) and site acceptance test (SAT) processes, Single Use Support offers customers various options of how to integrate testing into their existing production procedures.
