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...
Comparing autologous vs allogeneic cell therapies, it becomes apparent that they share both defining methodological key elements as well as various fields of application, including most innovative cancer therapies, there are significant difference...
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...
Human errors in the pharmaceutical industry are a cost burden for all participants in the supply chain. 30-40% of all deviations are being caused by some form of human failure in operative handling. Even in cases where the error is considered mino...
Pharma 4.0 is the vision of digitalized pharmaceutical manufacturing. The implementation of modern digital strategies into the production of pharmaceutical drugs promises increasing productivity, easier compliance, enhanced connectivity and improv...
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...
PUPSIT stands for pre-use post sterilization integrity testing. This method is performed once a sterilizing filter has been installed, and serves the purpose of filter integrity testing. PUPSIT ensures that the installed filter is functional duri...
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...
First achievements of digitalization in the pharma industry All along the journey of an API (active pharmaceutical ingredient) from research & development to production and distribution, Pharma 4.0 will contribute to a process optimization to ...
CAR T-cell therapy is a promising approach in cancer treatment. The therapy shows huge potential for patients suffering from acute lymphoblastic leukemia who thus far had a poor prognosis: Thanks to the emergence of CAR T-cell therapy, the 5-year ...
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...
