This week’s headlines include: Novartis strikes deal with Chinese firm to make Kymriah, Gene tweak kills whole population of malaria-carrying mosquitoes in lab, Congratulations. Your Study Went Nowhere, Gilead to Make Generic Hepatitis C Drugs and Cut Prices Up to 75%, With new blood test, Roche dives deeper into personal cancer care, and T-cell therapy for eradicating HIV reservoirs proves safe in small study.
Check out our podcast channel. We have over 20 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:
The annual Cell Series features 4 outstanding programmes: our long-running 7th Cell Culture and Bioprocessing, 5thStem Cell & Regenerative Medicine, 4th Cell and Gene Therapy and Biobanking Congresses. The Cell Series provides a focused networking platform targeting Cell Culture & Cell Line Development and Bioprocessing; Cell & Gene Therapy highlighting CAR T Cell Development; Stem Cell & Regeneration Medicine Development as well as Biobanking.
In Case You Missed It, Recent Articles on Cell Culture Dish
OverviewThe majority of gene therapy applications in development utilize viral vectors to carry the therapeutic gene into the target cells. Cells may be genetically modified either in vivo or ex vivo. In the ex vivo applications cells are modified in culture, which also allows for cell expansion and analytical characterization prior to re-infusion of the...
After decades of research, gene therapies now comprise much of the R&D and manufacturing pipelines in the United States and around the world. Huge strides in biological understanding and the development of key enabling technologies are at long last delivering on the promises of precision and personalized medicines. While there...
IntroductionhiPSCs cultivation can be challenging with lot-to-lot coating variations, tedious preparation and increased contamination risk. In particular, biological coatings may negatively impact downstream applications due to the presence of undefined extracellular matrix (ECM) components and growth factors. Another common struggle is decreased reproducibility of data due to an inherently complex...
Gene Therapy IndustryGene therapy is the use of a gene-modifying technology to repair, replace or correct damage in the body. The first approved gene therapy study was conducted by the National Institutes of Health (NIH) in 1989 and provided evidence for the first time that human cells could be genetically...
The interaction between cells and the extracellular matrices they are cultured on is extensive. In standard cell culture, cells are pulled from tissue, which provides a native extracellular matrix and are put onto tissue culture treated plastic. While most cells will ultimately adhere and grow on tissue culture treated plastic,...
In Case You Missed It, Recent Articles on Downstream Column
Robotics are becoming increasingly present in many different industries. In the medical world, robots and AI are helping medical professionals conduct procedures, understand the risk of surgical complications, and provide more precise patient care. But robotics and AI are still evolving to pave the way for a brighter future for new and improved medical possibilities. So how are robots changing the medical landscape and where are we headed from here?
Continuous biomanufacturing – Key drivers for adoption, economic modelling and regulatory considerations
The Medicine Maker recently published a multi-authored eBook on Continuous Biomanufacturing, titled, “The Continuous Way”. The publication includes seven articles covering the topic of continuous biomanufacturing from a variety of angles. I really enjoyed the eBook and it provided a great update on the current state of continuous biomanufacturing as well as information about key drivers for adoption, new economic modeling, and integration of continuous operations. Following is a sampling of articles with key highlights.
Diafiltration, while fulfilling several functions in protein purification, has also presented a major obstacle in achieving continuous biomanufacturing. Technologies launched over the last decade have moved the industry closer to completing an integrated end-to-end continuous bioprocessing platform; however adequately addressing continuous final ultrafiltration/diafiltration of drug substance has been challenging. Now, inline diafiltration offers a solution to both traditional bottleneck hurdles and continuous biomanufacturing platform gaps.
In this podcast and accompanying article, we interviewed Avril Vermunt, bioprocess hardware specialist at GE healthcare about transferring a process from non-GMP to GMP manufacturing, particularly how resource-intensive it is for process development and manufacturing groups. Avril has several years of experience working in the technology transfer group at a large pharmaceutical company. We discussed with her best practices and how being proactive and one step ahead can make the process more seamless.
In this podcast and accompanying article we interviewed Dr. Yuyi Shen, Principal Scientist, Grifols about the benefits of modeling downstream disruptive technologies to improve downstream bioprocessing and evaluating the financial impact of implementing these technologies.
“Novartis has enlisted Chinese manufacturer Cellular Biomedicine (CBMG) to make its $475,000 gene-modifying cancer treatment Kymriah as the Swiss drugmaker intends to win approval for the therapy in the world’s most populous country…”
“Scientists have killed a whole population of malaria-carrying mosquitoes in their lab by using modified genes that make the killer insects infertile. Researchers at London’s Imperial College used “gene drive” technology to spread a genetic modification that blocks female reproduction while letting male mosquitoes continue to spread those altered genes…”
“When we think of biases in research, the one that most often makes the news is a researcher’s financial conflict of interest. But another bias, one possibly even more pernicious, is how research is published and used in supporting future work…”
“Many large drug companies go to extraordinary lengths to fend off generic competition and extend the life of their patents, but Gilead today announced a highly unusual move in the opposite direction. In January 2019, the company will start selling “authorized” generic versions of two of its three hepatitis C (HCV) drugs, Epclusa and Harvoni, years before the patents on these drugs expire. The list price of the generics will be $24,000, which is about a quarter to a third of the price of the branded drugs…”
“Swiss drugmaker Roche upped its bet on personalized cancer treatment on Monday, saying it is now ready to sell a blood test around the world that can identify common gene mutations from solid tumors from a patient’s blood…”
“Antiretroviral drugs have revolutionized the treatment of HIV, the virus that causes AIDS, but they’re not considered a cure. That’s because HIV can hide in the body in “reservoirs” that can resurge at any time. Hence much of the HIV research that’s happening today is focused on combating HIV reservoirs…”