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...
With new medical therapies constantly being researched and approved, even insiders and experts might lose track of what is hot and what is not. More importantly, they might lose track of what is what in the jungle of research and new developments....
"Scalability" is and will remain an important topic in Biopharma. No matter what area of application, it will be necessary to scale-up or down at some point. Scaling-up from doing research in small lab environments with a handful of scientists to ...
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...
Frozen storage and shipping of drug substances is indispensable in the biopharma industry. Nevertheless, drug substances are precious and sensitive, not only requiring careful handling but also reliable protection throughout the entire logistic...
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 freezing b...
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...
There are many choices on how to freeze your biopharmaceutical bulk material. Some freezing methods focus on deep freezing while others long-term storage to hold temperature. But what is the most effective and efficient approach for my cold chain?...
In cooperation with Single Use Support and Biogen, Entegris has published a new white paper concerning the employment of single-use technology to control frozen bulk drug storage. Download now Single Use Support advocates the use of sing...
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.
