Quality-critical attributes particular to liposome drug products include physicochemical properties such as particle size distribution and morphology, e.g. their overall shape. Such properties will influence the biological activity and bio-distribution of liposomal-based drug and gene delivery platforms. Analytical techniques that provide objective and reliable information on liposome particle characteristics can thus help to improve product development processes and shorten the time to securing their final quality. Cryo-transmission electron microscopy (cryoTEM) combined with image analysis using proprietary Vironova Analyzing Software (VAS)…

  The Allegroâ„¢ XRS 20 bioreactor system is a single-use bioreactor technology designed for applications ranging from general life sciences research to seed train operations, and as a final stage reactor for small scale commercial production. In practice, many installed systems have been implemented into seed train and small scale GMP production operations, where operational simplicity and consistent results are key benefits for industrial users. In the application note summarized here, we report efforts to enhance the capabilities of the…

Modern bioprocess development requires accurate, high throughput analytical methods to match scaled-down, high-throughput screening, the application of DoE, and science-based decision making consistent with QbD. Gyrolabâ„¢ systems and Gyros’ immunoassay kits constitute a proven platform that supports these needs today and has the capability to meet future challenges. The assay principle uses high-capacity, flow-through affinity columns embedded within a CD. Centrifugal force, capillary action and hydrophobic barriers are exploited during parallel processing of up to 112 samples on each CD.…

Biopharma manufacturers need to transfer critical fluids from cleanroom to cleanroom quickly, aseptically, and with minimal effort and expense for maximum productivity. Traditional hard piping involves intensive cleaning operations and down time between uses. Portable tanks run the risk of damage and leaks and also present cleaning challenges. Incorporating Single-Use components and practices with in-wall transfer systems can help speed and streamline operations while maintaining isolated environments. These types of systems help remove the risk of breakage, spillage and lost…

During early stage drug development, quickly obtaining relevant candidate proteins through transient transfection can accelerate drug discovery. High titers are often obtained from Human Embryonic Kidney (HEK) 293 derived cell types; however, the use of different host cells between early stage transient and later stable protein production is a concern and can lead to the advancement of false-positive candidates. Chinese hamster ovary (CHO) cells are a desirable target cell type due to growth characteristics and a history of regulatory approval;…