This week’s headlines include: Cancer Deaths Continue a Steep Decline, Bluebird to seek approvals for three treatments by end of 2019, GE Healthcare And Roche Team Up To Build Data-Pooling Service For Hospitals, Pfizer Ends Its Neuroscience Program—What Does it Mean For Alzheimer’s, Roche’s emicizumab cleared for early access in the UK, and Adapsyn signs $162M microbe-mining deal with Pfizer.

In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

Novel technology enables encapsulated cell therapeutics without triggering fibrosis

In this podcast and accompanying article, we interviewed Dr. Paul Wotton, CEO, about Sigilon Therapeutics’ discovery platform. The platform combines cell engineering and biocompatible Afibromer^™ technology to enable cell therapeutics that do not trigger fibrosis…

Cool Tool – Xeno-free media supplement for Cell Therapy Manufacturing

Cell-based therapy has demonstrated significant promise in the potential to treat some of the most challenging diseases. The recent FDA approvals of Novartis’ Kymriah and Kite Pharma’s Yescarta demonstrate the tremendous benefits this industry has to offer. As more and more cell therapies progress towards commercialization, safe and efficient manufacturing becomes critically important. Because the cell is the therapy, materials and methods used to culture the cells are a key focus of regulators. It is easy to become inundated by the plethora of reagents available on the market and risk mitigation strategies are becoming differentiators. Several companies have looked to serum-free culture in an attempt to remove the variability associated with using animal source sera. However, the ex vivo manipulation necessary for Cell Therapy manufacturing creates a more challenging system for the cells to survive in and thus they have a tendency to struggle in serum free conditions. If the cells aren’t growing well, then manufacturing can’t meet the efficiency or timelines required to create a viable product…

Dissolvable microcarriers – Efficient and streamlined stem cell harvest for Cell Therapy biomanufacturing

We recently finished our Ask the Expert discussion, “Enabling Stem Cell Therapy Biomanufacturing using Dissolvable Microcarriers.” During this Ask the Expert session, we covered topics related to the large scale culture of stem cells for Cell Therapy and the use of dissolvable microcarriers as an enabling technology. Topics included general questions about the use of microcarriers in Cell Therapy manufacturing, for example, microcarrier optimization, cell aggregation when using microcarriers, and recommended scale for switching to microcarriers. In addition, we had several questions related to the use of dissolvable microcarriers that included, compatible cell types, cell attachement, cell harvest, media, bioreactor compatibility, and durability…

Development of an Improved Poloxamer 188 – Optimized for Cell Culture Performance

Poloxamer 188 is a surface-active non-ionic polymer used in cell culture media as shear protectant. With time it became a standard ingredient in cell culture media for commercial production processes. It was demonstrated to increase the robustness of mammalian cells to shear from sparging, which probably is the strongest contributor to the hydrodynamic stress in bioreactors…

The Top 25 Downstream Column Blogs of 2017

I have compiled a list of our most popular 25 blogs, podcasts, and webinars for 2017 listed in alphabetical order…

Protein A Chromatography – A look at where we have been and where we are going

In this podcast and accompanying article, we interviewed Jonathan Royce,  Business Leader, Chromatography Resins, GE Healthcare Life Sciences, about the evolution of Protein A including the latest developments in Protein A chromatography resins. We also discussed what the future holds for this purification mainstay and how it can continue to address the changing needs of biopharma…

Downstream Bioprocessing Cost Modeling – Looking at Integrated Continuous, Single-use and Stainless Steel Platforms

Process economics are frequently discussed with respect to continuous biomanufacturing implementation. More specifically, are the potential cost benefits worth making a manufacturing change and in which situations are the benefits greatest? At Biotech Week Boston in September, there was a very interesting talk titled “Cost modeling of the downstream bioprocessing design space,” presented by Mark Schofield, Ph.D., Senior R&D Manager, Pall Life Sciences. In the talk, Dr. Schofield shows data related to cost modeling the downstream bioprocess design space. He also describes some of the challenges facing biomanufacturing including cost pressure, competition, and the rise of biosimilars, and how implementing integrated continuous operations can address several of these challenges…

Resolving large scale buffer management challenges

In this podcast and accompanying article, we interviewed Joakim Lundvist, Modality Manager, BioProcess™ Hardware, GE Healthcare about large-scale buffer management challenges. Buffer preparation is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required. So how can this be done in a more efficient way? How can more capacity be added to buffer preparation without adding major capital investment? Are there ways to reduce the manufacturing footprint and time spent on buffers?…

Podcasts:

Check out our podcast channel. We have 15 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more!

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Headlines:

“Cancer Deaths Continue a Steep Decline,” The New York Times

“From 1991 to 2015, the cancer death rate dropped about 1.5 percent a year, resulting in a total decrease of 26 percent — 2,378,600 fewer deaths than would have occurred had the rate remained at its peak. The American Cancer Society predicts that in 2018, there will be 1,735,350 new cases of cancer and 609,640 deaths. The latest report on cancer statistics appears in CA: A Cancer Journal for Clinicians…”

“Bluebird to seek approvals for three treatments by end of 2019,” Reuters

“U.S. biotech bluebird bio Inc, which does not yet have any marketed products, expects to be able to file for regulatory approval of three novel treatments by the end of 2019, chief executive Nick Leschly announced on Tuesday…”

“GE Healthcare And Roche Team Up To Build Data-Pooling Service For Hospitals,” Forbes

“GE Healthcare and Roche have announced a long-term partnership to develop and market a digital system for hospitals that would combine patient data from continuous monitoring devices and in vitro diagnostics to help doctors make clinical decisions…”

“Pfizer Ends Its Neuroscience Program—What Does it Mean For Alzheimer’s?” Huffington Post

“Over the weekend, Pfizer announced it is closing its neuroscience division. In a statement, the company said it made the decision in order to “focus on those areas where our pipeline, and our scientific expertise, is strongest…”

“Roche’s emicizumab cleared for early access in the UK,” PharmaTimes

“Roche’s emicizumab in being included in the UK’s Early Access to Medicines Scheme for routine prophylaxis of bleeding episodes in patients with haemophilia A with factor VIII inhibitors…”

“Adapsyn signs $162M microbe-mining deal with Pfizer,” FierceBiotech

“Finding drugs amongst the metabolic soup of living organisms is a tough task, but Canadian biotech Adapsyn Bioscience has developed a system that could sift out promising candidates more quickly—catching the eye of a pharma partner. Pfizer’s venture arm Pfizer R&D Innovate just stumped up a financing round for the Hamilton, Ontario-based star-up along with Genesys Capital, which will fund its internal drug discovery efforts. And the big pharma has also earmarked $162 million for a project that will use Adapsyn’s platform to search through its collection of microbial strains…”