This week’s headlines include: Immunotherapy Drugs Slow Skin Cancer That Has Spread to the Brain, Novartis’ PI3K drug hits goal in phase 3 breast cancer trial, laying groundwork for talks with regulators, Congo approves 4 experimental Ebola treatments in outbreak, FDA extends EpiPen expiry date to combat shortage, Scientists Race To Improve ‘Living Drugs’ To Fight Cancer, and Exosomes from Cancer Cells Could Predict Immunotherapy Responses.

Headlines:

“Immunotherapy Drugs Slow Skin Cancer That Has Spread to the Brain,” The New York Times

“A new study offers a glint of hope to people in a desperate situation: Patients with melanoma, the most serious form of skin cancer, that has spread to the brain. A combination of two drugs that activate the immune system shrank brain tumors in many melanoma patients and prolonged life in a study of 94 people at 28 medical centers in the United States. The drugs were ipilimumab (brand name Yervoy) and nivolumab (Opdivo), and they belong to a class called checkpoint inhibitors…”

“Novartis’ PI3K drug hits goal in phase 3 breast cancer trial, laying groundwork for talks with regulators,” FierceBiotech

“Novartis’ PI3K inhibitor BYL719 has met the primary endpoint in a phase 3 breast cancer trial. The hit on the progression-free survival endpoint sets Novartis up to start talking to regulators about getting the drug to market…”

“Congo approves 4 experimental Ebola treatments in outbreak,” ABC News

“Congo has approved the use of four more experimental treatments in the Ebola virus outbreak in its northeast, as health officials try to contain the spread amid the threat from armed groups in the region. The treatments ZMapp, Remdesivir, Favipiravir and Regn3450 – 3471 – 3479 can now can be used on those suffering from Ebola, the health ministry said Wednesday. On Tuesday, health officials administered Remdesivir, which is produced by Gilead Sciences, to a patient in Beni, the ministry said…”

“FDA extends EpiPen expiry date to combat shortage,” Reuters

“The U.S. Food and Drug Administration on Tuesday extended the expiration date of specific lots of Mylan NV’s EpiPen allergy injectors by four months to mitigate the shortage of the life-saving treatment. The decision comes at a time when the shortage has come under focus at the start of back-to-school season, and applies to specific lots of 0.3 milligram EpiPen products, after the regulator reviewed data provided by Mylan…”

“Scientists Race To Improve ‘Living Drugs’ To Fight Cancer,” NPR

“Aaron Reid is lying in a hospital bed at the National Institutes of Health Clinical Center when doctors arrive to make sure he’s ready for his experimental treatment. “How’s your night? Any issues?” asks Dr. Katherine Barnett, a pediatric oncologist, as they begin to examine Reid. Reid, 20, of Lucedale, Miss., has been fighting leukemia since he was 9 years old. He has been through chemotherapy and radiation twice, a bone marrow transplant and two other treatments…”

“Exosomes from Cancer Cells Could Predict Immunotherapy Responses,” Genetic Engineering News

“A team of researchers from the University of Pennsylvania (UPenn) School of Medicine revealed that the exosomes (extracellular vesicles) that contain programmed death-ligand 1 (PD-L1), released by melanoma cells, are found far beyond the tumor microenvironment and could be purified from the plasma of patients. James L. Gulley, M.D., Ph.D., a senior investigator and the chief at the genitourinary malignancies branch of the National Cancer Institute, tells GEN “we have been so used to thinking about the PD-1/PD-L1 interaction in the tumor microenvironment, this work shifts it into a different light…we are going to start thinking about this differently now…”

Podcasts:

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:

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

Opportunities for Leveraging Biomedical Innovations in the Development of the Clean Meat Industry

Motivated by an interest in alleviating the immense environmental impact of intensive animal agriculture, the past two years have witnessed a surge in efforts to develop bioengineered products that directly replicate the cellular composition of meat. This wouldn’t be the first time technology developed in biomedicine has made the leap to the food industry. As demonstrated by the successful cross-application of recombinant protein production technology from human insulin synthesis to widespread food enzyme and ingredient production, the potential to revolutionize food product development with biomedical research is significant but largely unexplored. Scientists are now beginning to tap into this potential by utilizing animal cell culture advancements to make products that are referred to as clean meat because they are free of the environmental, public health, and animal welfare consequences of animal rearing, slaughter, and antibiotic use…

Increasing Process Development Workflow Efficiency by Integrating High Throughput Technologies

A strategy for increasing process development workflow efficiency by incorporating enabling high throughput technologies including ambr™ bioreactors, the Cedex™ Bio HT Analyzer, Sm@rtline Data Cockpit , and the Tecan Fluent™ pipetting robot. During this year’s PepTalk conference, there was a very impressive presentation given by Dr. Timo Frensing, Large Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Munich. The title of the talk was “Integration of high throughput systems into the USP development workflow and into the data acquisition, management and analysis system.” In the talk, Dr. Frensing described how his team was able to increase process development workflow efficiency through the incorporation of several enabling high throughput technologies…

Closed System Cell Therapy Manufacturing – Moving from the lab to clinical and commercial production

In this podcast, we conducted a panel discussion on key considerations for moving cell therapies from lab to commercial manufacturing, including the benefits of manufacturing in a closed system. We also discussed what were some of the key hurdles and possible solutions associated with transitioning to clinical and commercial cell therapy manufacturing…

Cool Tool – Intelligently Designed Cell Culture Dishes Address Common Cell Culture Scientists’ Complaints

Who hasn’t been in the lab and accidently bumped one of their cell culture dishes, spilling the precious contents? Or has struggled to grip a dish with gloved hands? Well most people don’t think of cultureware, especially cell culture dishes, as being particularly innovative, but there is a new cell culture dish…

Expansion of Mesenchymal Stem Cells in Blood-free, Chemically Defined Media

Last month’s ISCT conference held in Montreal, Canada featured many novel approaches for cell therapy research and manufacturing. One of the posters presented at the conference, “Inclusion of Recombinant Albumin and Transferrin Enables the Blood-Free Expansion of Mesenchymal Stem Cells in Chemically Defined Media,” highlighted the importance of blood-component free media for cell therapies and provided data on the use of a blood-free media in mesenchymal stem cell (MSC) culture…

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…

Cool Tool – Inline Diafiltration Closes the Gap for End-to-End Continuous Bioprocessing

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…

Start With the End in Mind – How to facilitate transfer from non-GMP to GMP Manufacturing

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…

Modeling Downstream Disruptive Technologies to Improve Downstream Bioprocessing

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…

Webinars

Cell Culture Heroes – Webinars on Cancer Research

Gibco Cell Culture Heroes spotlights PhD and post-doc cancer researchers across the globe with the primary focus of telling the story of their research. This program promotes education and creates a community amongst researchers who are driving tomorrow’s breakthroughs in the fight against cancer.
As a Gibco Cell Culture Hero you can present your research to a global audience via webinar and you will have the opportunity to share your story of success and perseverance to the world on thermofisher.com. Do you want your research to be highlighted as a Cell Culture Hero? Click here to learn more – https://www.thermofisher.com/us/en/home/products-and-services/promotions/life-science/cell-culture-heroes.html
View the on-demand webinars of current Cell Culture Heroes

Conferences:

BioProcess International Conference and Exhibition – September 4-September 7, 2018

The Largest Exhibition Devoted to Biomanufacturing
Capitalize on 225+ case studies and new data presentations from global thought leaders to improve integration, productivity and cost savings across the entire bioprocessing spectrum.
Grab your 3-day exhibit hall pass to BPI Boston, held September 5-7 at the Hynes Convention Center.  Exhibit hall passes start at $449, but register with VIP code DISH by July 27 and save an extra $100.

Cell & Gene Therapy Bioprocessing & Commercialization – September 4 – September 7, 2018

Bringing together 300+ leaders and key influencers from pharma and biotech companies this September in Boston, Cell & Gene Therapy Bioprocessing & Commercialization 2018 will provide you with the latest advice for driving manufacturing and commercialization through direct access to innovative discovery, product development and regulatory know-how. Discover everything you need in one place as you move between 4 tracks jam packed with topical talks and industry case studies, and meet with colleagues for an unrivalled on-site experience.