This week’s headlines include: F.D.A. Approves Second Gene-Altering Treatment for Cancer, Abandoned blood cancer drug resurrected by San Diego startup, WuXi AppTec continues worldwide expansion with ResearchPoint Global buy, Genomics England links with Inivata, Thermo Fisher, Report: Pollution Kills 3 Times More than AIDS, TB And Malaria Combined, and Relationship between sugar and cancer is now clearer, scientists say.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Hydrodynamic stress in bioreactors and specifically shear caused by sparging can present a challenging issue in commercial biopharmaceutical manufacturing. A solution was found in the use of Poloxamer 188, a surface-active, non-ionic polymer that when added to cell culture media acted as a shear protectant. Poloxamer 188 became a standard ingredient in cell culture media for commercial production…
In this podcast and accompanying article, we interviewed Ken Clapp, a senior member of GE Healthcare Life Sciences’ upstream product management team. We explored in more detail the implementation of single-use systems for microbial fermentation including which processes make good candidates for single-use and considerations for transitioning from stainless steel…
We recently finished our Ask the Expert discussion, “Everything you ever wanted to ask about Corning® Matrigel® Matrix”. During this Ask the Expert session, we had a wide range of questions and discussed everything from storage and handling recommendations to Matrigel for 3D bioprinting. Specific topics included Matrigel best practices for: culturing a variety of cell types, imaging, analytical methods, cell invasion assays, harvesting, and 3D culture…
Immunotherapy, particularly for cancer treatment, is a very active area of both academic and clinical research. There has been increased interest in utilizing a patient’s own T cells to attack their tumors. However, positive laboratory results do not always translate from bench to the clinic, and the effectiveness of immune cells therapies are not equivalent for all patients or cancer types. To better understand these differences, there is a need for improved in vitro oncological models that more closely resemble the tumor environment in vivo. Traditionally, tumoricidal activity and immune evasion have been studied by utilizing two dimensional systems (2D) which may not accurately reflect the complexity of a three dimensional (3D) tumor. The physical barriers immune cells need to overcome in a 3D system are much greater than those of 2D. Not only do immune cells need to migrate to the tumor site, but they also need to infiltrate a 3D structure in order to attack the target cells. Furthermore, it has been shown that phenotypic differences occur in 3D-cultured tumor cells that allow for a higher resistance to cytotoxicity1-2. Here, we demonstrate a novel, high-throughput 3D model to study cancer/immune cell interactions by combining two commercially available products; 96 well ultra-low attachment microplates and 96 well permeable support systems. By replacing the standard 2D flat-bottom permeable support receiver plate with an ultra-low attachment microplate, an easy-to-use, 3D, high-throughput assay to investigate immune cell homing, tumor cytotoxicity, and tumor immune evasion is achieved…
Concentration of biological drug substances is an important step at various stages in biomanufacturing. Concentration is often necessary between chromatography steps, in post harvest, during pre-capture or for in-process volume reduction. Concentration may also be needed between chromatography steps.
During concentration applications, there is a potential for aggregation, particularly with sensitive biologics even when they are only slightly stressed. Therefore, an effective concentration system must operate efficiently under mild conditions while at the same time being flexible enough to integrate readily with different downstream operations…
Cool Tool – ‘Jetting’ technology for manufacturing agarose beads with enhanced performance characteristics
The vast majority of chromatography resins designed for large-scale bioprocess chromatography separation are produced using traditional batch emulsification in conventional stirred-tank reactors. In these cases, the size of the beads formed in the reactor is a function of the shear force generated by the impeller. The faster the impeller speed, the smaller the beads are. As a result, there is a wide particle size distribution of the manufactured beads. Furthermore screening is required to remove coarse and fine beads, which detract from column performance. This screening is extremely time consuming particularly for smaller beads (less than 65 µm). The smaller the bead being produced the lower the achieved yield so realistically one cannot make beads financially viable less than 40 µm. It also adds high costs due to the additional time in the manufacturing facility with large volumes of waste from the fine and coarse beads. Even after this screening, the resin will still have a relatively wide size particle distribution…
In examining ways to improve overall bioprocess efficiency, filtration is a step that can sometimes be overlooked. However it is a key area to improve efficiency, as it is part of both upstream and downstream operations and consumes sizeable resources. The application of single-use technologies coupled with increased automation have successfully improved efficiency in other bioprocess operations, thus it is logical that filtration would also benefit from these technologies…
Bioburden Contamination in Downstream Bioprocesses – Potential entry points for contamination and innovative solutions
Bioburden contamination in biopharmaceutical manufacturing is a big concern. Contamination carries both tremendous cost and preventing it requires strict control of several possible entry points. The cost of bioburden contamination for a company can involve lost time, lost material, batch loss, possible facility closure and extensive QA/QC time to ensure proper cleaning and validation. In the worst case scenario, it can prevent supply of much needed medicine to patients and loss of commercial revenue…
Do you have a burning regulatory question? Come and get your queries answered with 4 parallel conference tracks on Regulatory Affairs in Emerging Markets, IDMP, Global eSubmissions and Biosimilars. We offer a new central European location, a focused agenda and more opportunities for you to collaborate and connect.
To learn more, please see – https://lifesciences.knect365.com/global-pharma-regulatory-affairs/
3rd Annual Cell & Gene Therapy Congress
November 6 – November 7
immarsat, 99 City Road
London, EC1Y 1AX United Kingdom
Oxford Global Conferences presents its 3rd Annual Cell & Gene Therapy Congress, with our co-located 6th Annual Cell Culture & Bioprocessing Congress and 4th Annual Stem Cell Congress and, 6 – 7 of November 2017, London, UK.
Cell & Gene Therapy: Development & Clinical Trials Cell Therapy Bioprocessing and Manufacturing Presentations will include cell & Gene Therapy development, updates in regulatory pathways, commercialisation, bioprocessing and manufacturing.
World Orphan Drug Congress Europe
November 13 – November 15
FAIRMONT REY JUAN CARLOS I, Av. Diagonal, 661-671
BARCELONA, 08028 Spain
The 8th annual World Orphan Drug Congress is the marketplace for orphan drug professionals looking at the complete value chain of orphan drug development, from clinical development and R&D to corporate development and market access.
“The Food and Drug Administration on Wednesday approved the second in a radically new class of treatments that genetically reboot a patient’s own immune cells to kill cancer. The new therapy, Yescarta, made by Kite Pharma, was approved for adults with aggressive forms of a blood cancer, non-Hodgkin’s lymphoma, who have undergone two regimens of chemotherapy that failed…”
“An experimental blood cancer drug shelved for safety concerns is being brought back to clinical development. San Diego startup Impact Biomedicines said Friday it has raised $22.5 million from the venture capital firm Medixci to help get the drug to market. Called fedratinib, the drug treats the bone marrow cancers polycythemia vera and myleofibrosis…”
“As WuXi AppTec awaits being relisted on the Chinese stock market, it hasn’t halted expansions. The Shanghai-based biopharma research enabler has acquired U.S.-based CRO ResearchPoint Global (RPG). Once the acquisition closes, RPG will become a wholly owned subsidiary of WuXi, with its service integrated with WuXi’s existing China-based, 500-member clinical development service team—or a CRO in the traditional sense—plus 1,000 clinical research coordinators under its site management organization (SMO)…”
“Genomics England is linking with leading life sciences companies Inivata and Thermo Fisher Scientific in a collaboration that strives to improve understanding of cancer. The pilot project will assess the quality of blood plasma samples and explore the potential of liquid biopsy testing in order to boost disease management and patient outcomes…”
“Exposure to polluted air, water and soil caused nine million premature deaths in 2015, according to a report published Thursday in The Lancet. The causes of death vary — cancer, lung disease, heart disease. The report links them to pollution, drawing upon previous studies that show how pollution is tied to a wider range of diseases than previously thought…”
“Belgian scientists say they’ve made a research breakthrough in the relationship between sugar and cancer. Researchers found yeast with high levels of the sugar known as glucose overstimulated the same proteins often found mutated inside human tumors, making cells grow faster. The finding, published in Nature Communications on Friday, aims to shed light on how cancer develops…”