This week’s headlines include: T-cell therapy for eradicating HIV reservoirs proves safe in small study, Flu Virus Explodes in Some Cells, Fizzles in Others, Alzheimer’s cases to nearly triple by 2060, CDC says, Scientists Create Immature Human Eggs From Stem Cells, Acadia Pharma Soars After FDA Investigation Clears Nuplazid of Additional Safety Problems, and Raising Awareness of BRCA Mutations.

Headlines:

“T-cell therapy for eradicating HIV reservoirs proves safe in small study,” FierceBiotech

“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…”

“Flu Virus Explodes in Some Cells, Fizzles in Others,” Genetic Engineering News

“Ostensibly, the concept of inequality may have some origins in the viral world, as scientists from the University of Minnesota (UMN) Medical School have recently discovered that the influenza virus does not replicate equally in all cells. The investigators found that not only is the immune system response tuned to the amount of virus replication, it’s also tuned to the viral spread. This deeper and more accurate understanding of the influenza virus and how it spreads could be the building blocks to better protective therapies for patients in the future. Findings from the new study were published recently in PNAS through an article titled “Distinct antiviral signatures revealed by the magnitude and round of influenza virus replication in vivo.”…”

“Alzheimer’s cases to nearly triple by 2060, CDC says,” NBC News

“The number of people with Alzheimer’s disease will nearly triple over the next 40 years, unless something dramatic happens to change trends, the Centers for Disease Control and Prevention said this week…”

“Scientists Create Immature Human Eggs From Stem Cells,” NPR

“Scientists say they have taken a potentially important — and possibly controversial — step toward creating human eggs in a lab dish. A team of Japanese scientists turned human blood cells into stem cells, which they then transformed into very immature human eggs. The eggs are far too immature to be fertilized or make a baby. And much more research would be needed to create eggs that could be useful — and safe — for human reproduction…”

“Acadia Pharma Soars After FDA Investigation Clears Nuplazid of Additional Safety Problems,” BioSpace

“Shares of Acadia Pharmaceuticals soared more than 26 percent in trading on Thursday and continue to climb this morning in premarket trading after the U.S. Food and Drug Administration (FDA) affirmed the safety profile of the company’s lead drug, Nuplazid. Nuplazid had been under scrutiny by the regulatory agency since April when a report raised concern over a number of deaths and adverse events linked to the medication. Nuplazid, a selective serotonin inverse agonist that targets 5-HT_2A receptors, was approved by the FDA in 2016 for hallucinations and delusions associated with Parkinson’s disease psychosis. Nuplazid was the first drug of its kind for this indication. In April, an analysis released by the nonprofit Institute for Safe Medication Practices indicated that 244 deaths had been reported to the FDA between the time Nuplazid became commercially available and March 2017. The report also questioned the efficacy of the medication…”

“Raising Awareness of BRCA Mutations,” The New York Times

“You don’t have to be Jewish to inherit one of the BRCA gene mutations. But these mutations, which increase the risk of adult-onset breast, ovarian, prostate and other cancers, disproportionately injure Jewish people. One in 400 people in the general population carry a BRCA mutation; one in 40 in the Jewish (mostly Ashkenazi) population. Some of those affected are working to encourage more genetic testing to help prevent these cancers…”

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

Overview of the Regulatory Path to Commercializing a Gene Therapy

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 is still much more to learn and develop, regulatory constructs keeping pace with the speed of innovation remains a sizeable challenge…

A Defined Synthetic Growth Surface for Stable hiPSC Expansion

hiPSCs 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 and non-defined growth surface. To address these common challenges, Eppendorf has introduced a ready-to-use consumable with synthetic fibronectin-derived motifs to support stem cell attachment by mimicking the native ECM protein fibronectin. The FN1 motifs surface allows expansion of stem cells in various xeno-free media and other restrictive culture conditions. Thus, you can establish a completely defined culture system for your stem cell culture without any animal or human components…

Key Considerations for Gene Therapy Commercialization

Gene 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 modified and returned to the patient without harm. To date, approximately 2,600 clinical trials and six gene therapy products have been approved in various countries…

The Next Evolution in Stem Cell Culture™: Cell-Derived Extracellular Matrices

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, their gene expression and proliferation is often different from in vivo…

The Impact of Trace Elements on Cell Culture Media and Upstream Processing

Despite the high efficacy and target specificity of biopharmaceutical drugs, there are still multiple challenges associated with achieving efficient production of therapeutic proteins. These include discovering new approaches for maximum protein expression, developing economical, flexible and robust manufacturing processes to maximize product yields, and solving the complex challenges of refolding proteins into their active state…

How Robots Are Changing The Landscape Of The Medical Field

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….

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…

Upcoming Conferences

CELL SERIES

The annual Cell Series features 4 outstanding programmes: our long-running 7^th Cell Culture and Bioprocessing, 5^thStem 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.

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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
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Technical Training

Continuous Downstream Processing

September 27-29, 2018

Attendees will learn everything from the basics of biotechnology through to customized process design, development and optimization in biomanufacturing.