This week’s headlines include, Wyss Institute launches organ-on-chips startup, GSK submits world’s first malaria vaccine, new blood-based cancer drug tests, U.S. paves way for biosimilars, NIH spurs innovation in new therapeutic areas, new cell-squeezing method for reprogramming cells, and technique for efficiently obtaining stem cells.
Cell Culture Dish – Ask the Expert Session
Our Next Session – Single-Use Technology for Microbial Fermentation
Microbial fermentation processes are used for biomanufacturing of various drugs and vaccines, such as hormones, antibody fragments, and pneumococcal vaccine. Stirred-tank fermentors up to 100,000 L scale have traditionally been used in such microbial processes and their success has formed the general engineering foundation and principles of the design of bioreactors. The majority of today’s fermentation processes are performed in bioreactors constructed of traditional materials such as stainless steel. However, there is an increased interest in disposable technology to gain flexibility, save batch change-over time, and minimize cleaning and cleaning validation efforts.
Cell Culture Events
The Bioprocessing Summit – August 18-22, 2014 – Renaissance Waterfront Hotel – Boston, MA
“GlaxoSmithKline (GSK.L) said on Thursday it is applying for regulatory approval for the world’s first vaccine against malaria, designed for children in Africa. The British drugmaker said the shot, called RTS,S, is intended exclusively for use outside the European Union but will be evaluated by the European Medicines Agency (EMA) in collaboration with the World Health Organisation (WHO).”
If you like this story, please see our blog titled “Single-use Perfusion Culture Enables Continuous Bioproduction“
“The National Institutes of Health is launching three new programs in emerging areas with the lofty goal of transforming biomedical research in the next 5 to 10 years. The initiatives, supported by the NIH’s Common Fund, include work on the effect of sugar modifications on proteins, the arrangement of DNA within cells in four dimensions, and the development of new therapies that allow control of organ function through manipulation of nerves.”
If you like this story, please see our blog titled “Single-use Technology for Microbial Fermentation”
“A newly created startup called Emulate has picked up and plans to commercialize “Organs-on-Chips” developed at Harvard’s Wyss Institute for Biologically Inspired Engineering and intends to use them to speed up the development of pharmaceutical, chemical, cosmetic, and personalized medicine products, following an agreement made between the new private firm and Harvard’s Office of Technology Development.”
If you like this story, please see our blog titled “Using Induced Pluripotent Stem Cells to Model Human Disease”
“U.S. regulators have accepted an application by Sandoz – the generics arm of Novartis – seeking approval for a copycat version of Amgen’s drug Neupogen, or filgrastim, for patients with low white blood cell counts. The Food and Drug Administration’s decision to accept the filing under a new pathway for so-called biosimilar drugs marks a milestone in the rollout of cheaper copies of injectable biotech medicines in the United States.
If you like this story, please see our blog titled “Paper or Plastic: A Study on Single-use and Sustainability”
“AstraZeneca has signed up Roche and Qiagen to develop two separate diagnostic tests, both using simple blood samples, to identify patients who will benefit from its lung cancer drugs. Currently testing patients to see if their tumours contain genetic mutations that make them suitable for drug treatment involves collecting a sample of tissue by needle biopsy or during surgery.”
If you like this story, please see our blog titled “Flexible Facilities for Biopharmaceutical Manufacturing”