Bio-therapeutic manufacturing requires precise control of process parameters throughout production to ensure high yield and high quality products that are safe for patient use.
This application note describes mixing and heating-cooling characterization data for the Xcellerex XDM 50 single-use mixer. A design of experiments approach to liquid-liquid mixing was successfully applied to establish a model to predict the mixing time throughout the working range.
Thermo Scientific™ Nunc™ Cell Factory™ systems are solutions designed for adherent cell culture. These systems consist of multiple polystyrene growth surfaces, assembled together to maximize the surface area available for cell growth while minimizing the incubator volume required for maintaining cells. Nunc Cell Factory systems are popular in fields where large quantities of cells are required and are a reliable tool for the production of vaccines, recombinant proteins, and for the generation of cell mass.
This case study shares the work of GE’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies.
The next-generation Thermo Scientific™ HyPerforma™ Single-Use Mixer (S.U.M.) provides enhanced functionality, ease-of-use, and efficiency for critical up- and downstream process liquid preparation.
The latest “trend” in oligonucleotide therapeutics is the development of therapeutic siRNA molecules. As its name suggests, RNA interference (RNAi) is a cellular mechanism regulating the expression of genes and also the replication of viruses.
Manufacturing biopharmaceutical products on an industrial scale has required scaling up a variety of techniques that were previously only practiced at bench scale. This includes highly technical and notoriously difficult processes such as cell culture; maintaining living cells in a tightly controlled sterile environment.
The growing public awareness of a potential pandemic requiring rapid treatment of millions of healthy individuals has spurred renewed interest in vaccines. Vaccine development timelines vary from being only a fraction of other biotherapeutics to decades of research and efforts to find an effective vaccine. Vaccination campaigns mean that often very large quantities need to be manufactured, maintained, and distributed.
The pilot scale synthesis instruments from GE Healthcare, ÄKTA oligopilot 10 and ÄKTA oligopilot 100 have been upgraded in regards to hardware, software, and synthesis methods. As a result of the upgrade, ÄKTA oligopilot plus 10 has become a highly efficient system for 1-µmol scale synthesis of DNA oligonucleotides
Because of the numerous challenges involved in the roller compaction of low dose active pharmaceutical ingredients, Patheon, Inc. recently conducted a study to determine the optimal design space and scale up conditions for such an application. They also set out to minimize the amount of active pharmaceutical ingredients needed in the early stages of drug development in order to save on costs and overcome short supply issues that are typical during the earlier stages of drug development. Read on to learn what they found out.
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