Life sciences companies engaged in the transition from clinical to commercial scale are challenged by the ability of current suppliers to meet the demand for materials and services as the volume of source ingredients is increased and production capacity and yield are stabilized. In the case of cell and gene therapies, and related personalized medicines, these source materials directly correlate to specific patient populations, with related constraints.
How digital PCR technology is helping scientists in their quest to break through the current limits of nucleic acid detection and quantification.
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
Single use connection technologies are expected to play a critical role in commercial manufacturing of cell and gene therapies. Learn about the types of connection technologies and selection considerations.
Successful cell cryopreservation requires a controlled cooling rate. Cooling too rapidly or too slowly will lead to a poorer outcome. This study shows comparable results when freezing cells with or without a rapid-cooling nucleation step.
With up to five lasers and 30 analysis parameters, the ZE5™ Cell Analyzer is well equipped for complex multiplex analysis of cells. It is able to successfully perform large panel immunophenotyping and can also distinguish a wide range of bead sizes and mixed microbial populations.
Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.
Digitally enabled cryogenic cold chain technology can now deliver the raw materials needed to manufacture cellular therapies
Evaluating how much a process step contributes to viral clearance is an essential part of process validation in order to be sure you are manufacturing safe drugs. Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.
A demonstration of a simple workflow to verify the reliability of the S3e Cell Sorter in sorting single cells.
Does the human body have the capability to heal itself? The idea of immunotherapy, harnessing the body’s own immune system to eradicate disease, has moved from the realm of possibility to something much more tangible. Interestingly, this promising therapy is not a new concept and has actually existed for more than 125 years, originating when William Coley, MD introduced the notion that the immune system could be useful in the treatment of cancer. He had observed that bone and soft tissue sarcoma patients experienced remission as a result of a concurrent bacterial infection and began to treat patients with heat-killed streptococcal organisms that he called Coley toxins. The toxins he administered to patients resulted in a 50% near-complete remission rate (Institute for Clinical Immuno-Oncology 2015).
As the cell and gene therapy landscape continues to mature, so too do the intricacies of commercialization. Inside the pages of this free collection of articles, you’ll find insightful data addressing the challenges critical for the sustainability of cell and gene therapy business models.
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