“For the first time, researchers have estimated what percentage of cancer mutations are due to environmental and lifestyle factors, hereditary factors and random chance. Overall, 66% of the genetic mutations that develop into cancer are caused by simple random errors occurring when cells replace themselves, according to a new study published in the journal Science. Environmental factors contribute 29% of mutations, while the remaining 5% are inherited, say Cristian Tomasetti and Dr. Bert Vogelstein, both of Johns Hopkins University…”
“A drug that can reverse aspects of ageing has been successfully trialled in animals, say scientists. They have rejuvenated old mice to restore their stamina, coat of fur and even some organ function. The team at Erasmus University Medical Center, in the Netherlands, are planning human trials for what they hope is a treatment for old age…”
“A new vaccine against a diarrheal disease that kills about 600 children a day worked well in a large trial in Africa and appears to be a practical way to protect millions of children, scientists said on Wednesday. The new vaccine against rotavirus, the most common cause of death from diarrhea in children under age 5, is made by an Indian company and was tested in Niger by Doctors Without Borders…”
“The cost to healthcare companies for U.S. regulatory review of their products, including drugs and medical devices, would more than double under the Trump administration’s proposed 2018 budget. For 2018, the Trump administration has budgeted over $2 billion in fees to be collected by the U.S. Food and Drug Administration from industry, twice as much as in 2017, according to budget documents released on Thursday…”
“Cell Medica Raises £60M for Phase II T-Cell Product and Cell Immunotherapy Pipeline,” Genetic Engineering News
“Cell Medica raised £60 million ($74 million) in a Series C round of financing to support development of its cell-based immunotherapy platforms and pipeline, including lead mid-stage oncology candidate baltaleucel-T (CMD-003). The autologous T-cell therapy is being evaluated in the Phase II CITADEL study and the CIVIC trial as a treatment for advanced lymphomas associated with Epstein Barr virus (EBV)…”
“When it comes to predicting who’s at risk of suffering a heart attack or other major cardiac event, physicians have long relied on detecting high levels of C-reactive protein (CRP), an inflammatory biomarker. But new research suggests CRP may not be the only game in town…”
Accelerating the development of regenerative therapies: Large scale expansion of human mesenchymal stem cells – March 28, 2017
Pall has partnered with RoosterBio to commercialize Allegro™ Unison human mesenchymal stem cells (hMSCs) and bioprocess media to accelerate cell therapy and regenerative medicine development. Use of Allegro Unison products along with SoloHill microcarriers, Allegro biocontainers, and the PadReactor® bioreactor system moves the industry towards execution of the technology roadmap to achieve lot sizes of 100s of billions to >1 trillion hMSCs, without the need for extensive and costly process development. Large scale hMSC expansion is now rapidly achievable in a robust, scalable, reproducible, and economic manner.
This webinar details the total solution for large scale expansion of human mesenchymal stem cells. We will present a case study highlighting large scale cell culture and expansion of hMSCs to billions of cells, within ten days of culture, in a fed-batch 50L bioreactor system.
Register to Learn:
- How Allegro Unison hMSCs and bioprocess media, SoloHill microcarriers and Pall PadReactor systems enable large-scale hMSC expansion.
- Culture protocol for 200-fold hMSC expansion, within 10 days, in a single-use, fed-batch scalable manufacturing platform.
- How regenerative medicine and cell therapy developers can rapidly and economically move towards producing tens of billions to >1 trillion high quality hMSCs for product development programs in single-use bioreactors.
The success of developing a cellular therapy rests on the ability to deliver a viable, potent product. This positive end-result is directly attributable to the strategy in place and the supporting processes. A reliable cell therapy development strategy is imperative to ensuring your therapeutic materials remain viable from the point of collection, through manufacture, to the final clinical site delivery.
This webinar will review some of the key components to consider when developing your strategy to minimize risk, manage cost, and ultimately deliver a product to market.
Key Learning Objectives:
- Minimizing variability through the use of collection and administration kits and SOPs
- Understanding the importance of validating process and qualifying equipment as well as data collection early and throughout Study/Phase 1 to commercial
- Leveraging data to maintain cell integrity, improve process, reduce risk, analyze and strengthen weak points
- Maintaining chain of custody and real time communications
- Understanding the importance of tracking and monitoring to ensure the right patient receives the right material at the right time
- Considering scalability from Day 1