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...
When CDMOs plan to expand their production capacities based on single-use technologies, it is tempting to either implement existing spare platform systems or simply "copy paste" used equipment - especially for greenfield facilities. However, it is...
Cell monolayers are an ideal method and widely used in the discovery of new drug compounds and the study of cell biology. Until now, there was no cryopreservation technology available to store cell banks pre-plated commercially. The conventional a...
The processes of cryogenic freezing and cryopreservation are considered essential in biotechnology for the conservation of biomaterials. Regenerative medicine and other disciplines in life sciences were allowed to make huge leaps in the treatment ...
With the emergence of many innovative approaches in the biopharmaceutical industry in recent years, life sciences companies have needed to put increasing efforts into pharmaceutical cold chain management. Many newly developed, highly sensitive ...
When dealing with the proper handling of some of the most innovative biologics – whether they are already on the market or still in the stage of clinical trials –, ultra-cold freezing and storing is a necessity. Since many pharmaceutical substanc...
Extractables and leachables are contaminants that are causing biopharmaceutical manufacturers headaches, as they can lead to impurities of highly valuable drug products. The FDA defines the two terms as follows: Extractables are compounds that c...
If you are considering switching your operation to single-use tubing, you are not alone: With more and more manufacturers in the pharmaceutical and bio-processing industries replacing their established systems with single-use set-ups, all kinds of...
Aseptic bag filling is a process that is very important to the biopharma industry. For the process, aseptic bag filling machines are used specifically. The technique of aseptic packaging is applied when sterilization of medical applications is no...
Inline buffer dilution is a method for on demand buffer preparation at the point of use. It has been subject to optimization and automation for decades and is increasingly used in single-use systems, in upstream, downstream and fill & finish p...
In a comprehensive study the impact of ice front growth speed on scalability of freezing protein solutions has been evaluated. Controlling the freezing behavior of drug substance is the ultimate goal in pharmaceutical manufacturing. It opens do...
With single-use technology becoming more and more prevalent in the pharmaceutical and medical sector, there is an increased need for solutions that are applicable across the board. Single-use tubing and manifold assemblies for sterile filling are...
[[ToC]] Filter manufacturers in the medical field – Which are the sterile membrane filters you can trust? Small particles or molecules are removed by membrane filtration in order to obtain absolutely sterile products. The sterile filtration in t...
