This week’s headlines include: Bill and Melinda Gates Grade the World’s Health, How poliovirus unleashes an attack on glioblastoma, FDA Grants Orphan Drug Status to Amylyx’s AMX0035 for Treatment of ALS, Pain Therapeutics Wins Grants to Develop Alzheimer’s Blood Test and Fentanyl Patch, and Pfizer, and Astellas prostate cancer drug promising in late-stage trial.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:BPI East 2017 begins September 25th in Boston. The conference is focused on providing companies the opportunity to share ideas, strategies and solutions to overcome challenges at every stage of development. Cell Culture Dish/Downstream Column will be attending and blogging from the event. Please don’t miss our BPI East related blogs over the next month. If you are attending, don’t miss these exciting talks and activities!
Transcriptome analysis reveals strategies for CHO cell culture media design and feed-spiking strategy to improve batch cultureWhen looking at batch vs. fed-batch culture, there are advantages and disadvantages to each, so considering the application is very important. Batch cultures are fairly simple, straightforward and take very little time to set up. However, batch culture typically doesn’t yield high mAb titers, due to nutrient depletion, by-product accumulation and short growth and production phases. So a batch approach may be good for lab-scale processes where product needs to be generated quickly and simply with little optimization. In contrast, with fed-batch culture, feeds are added to replenish nutrients, which increases cell concentrations, process time, and can yield much higher titers. However, fed batch culture also requires more time for optimization and resources to run. So this approach is more beneficial in situations where you would are developing long term processes or scaling up to large-scale production…
Cool Tool – ‘Jetting’ technology for manufacturing agarose beads with enhanced performance characteristicsThe 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…
Bioburden Contamination in Downstream Bioprocesses – Potential entry points for contamination and innovative solutionsBioburden 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…
SeptemberBioprocess International Conference (BPI East) September 25-28, 2017 Hynes Convention Center, Boston, MA The largest bioprocessing event bringing you the science, technologies and partners needed to accelerate promising biologics towards commercial success. BPI provides the solutions needed to move drug candidates closer to approval. Connect with 1800+ bioprocessing leaders at BPI Boston Sept 25-28. Register w/ code DISH200 by Sept 20 & Save $200 www.BPIevent.com Don’t miss our activities highlight blog –
OctoberWorld Vaccine Congress October 10 – October 12 CROWNE PLAZA BARCELONA, BARCELONA, Spain Make sure you are at the forefront of the vaccines industry. No matter where your interest lies, at the 18th annual World Vaccine Congress we have content, networking and potential partners for you. Speed to IND for Biologics October 19 – October 20 Hyatt Centric Fisherman’s Wharf, 555 North Point Street San Francisco, 94133 United States With 32 expert presenters, 20 case studies/new data presentations and just two days out of the office, you won’t want to miss this first-of-its-kind event!
November3rd 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.
“Bill and Melinda Gates handed the world a report card last week, assessing its progress on 18 global health indicators: infant mortality, AIDS, vaccine use, smoking rates and so on. Called “Goalkeepers,” the report was a huge statistical effort, three years in the making, aimed squarely at the world leaders gathering at the United Nations General Assembly this month. To draw extra attention to it, the Gateses will hold an awards dinner and a public release this week featuring former President Obama…”