This week’s headlines include: A Centennial of Death: The Great Influenza Pandemic of 1918, Biogen and Eisai try to defend Alzheimer’s drug BAN2401 against skeptics, FDA Approves Xofluza: What Makes This New Flu Treatment Different, Sanofi drug Dupixent wins FDA approval to treat asthma, CDC says polio-like disease is puzzling. These doctors disagree, and Two trial wins for Roche’s immunotherapy Tecentriq.

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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.

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

Biologicalisation is Coming of Age

One of this year’s Nobel Prize in Chemistry winners was Frances H. Arnold.  This Linus Pauling Professor at the California Institute of Technology had invented systems for the directed evolution of enzymes that are now routinely used to, e.g., develop catalysts for manufacturing.  Importantly, this includes supporting more environmentally friendly manufacturing of such chemical substances as pharmaceuticals and renewable fuels [1].  This event could be considered an inauguration of a much larger recent initiative to transform our manufacturing methods by the incorporation of biological and bio-inspired principles, materials and functions.  It’s noteworthy that this is only the fifth woman in history to have received the prize in Chemistry.  As it is her work that promises to contribute to this next revolution in manufacturing, we find it emblematic of our long-neglected recognition of women’s contribution in science…

Rapid Real-Time PCR-based Mycoplasma Testing for In-Process Control and Lot Release

In this mini-webinar and accompanying article, Martina Sauert, PhD and Carl-Ulrich Zimmerman, PhD of Mycoplasma Biosafety, an independent service provider specialized in the field of mycoplasma testing, discuss the shortcomings of traditional mycoplasma testing methods and the risks associated with mycoplasma contamination in biomanufacturing. They share the manufacturing points where mycoplasma testing is required by regulators and how rapid real-time PCR-basedtesting systems permit in-process mycoplasma testing as part of a quality by design (QbD) approach…

State of the Art CO2 Incubators Offer Safe Haven for Sensitive Cells

Cell culture CO2 incubators are a critical part of the cell culture process as cells spend most of their time here. The CO2 incubator’s purpose is to create ideal living conditions for cells to thrive, however this is not always achieved, sometimes not even visible at first glance. Environment variation and contamination are common challenges and both can cause experimental variation. Experimental variation can compromise years of research and investment. With sensitive cells, such as stem cells and primary cells, the amount of variation it takes to make an impact on cell health is decreased…

Viral Vector Characterization: A Look at Analytical Tools

As cell and gene therapy field continues to push products through the clinical landscape, the need to develop appropriate analytical tools has become increasingly evident. Because of their intended use in patients, gene therapy products must meet rigorous safety guidelines highlighting the importance of well-characterized analytics…

Isolation of Mononuclear and Polymorphonuclear Leukocytes from Blood with Density Separation Media

Blood is a specialized body fluid composed of four main components: plasma, white blood cells (leukocytes), red blood cells (erythrocytes), and platelets (thrombocytes). Unlike red blood cells and platelets, all white blood cells are nucleated and can be classified by their nuclei structure as mononuclear or polymorphonuclear cells…

A Guide for Selecting the Correct Filter Integrity Test Instrument

Selecting the right filter integrity test instrument is an important task. An informed, balanced choice will support the seamless integration of the instrument into critical processes and provide trouble-free operation for years to come. The right choice may be made more difficult by different departments, or user groups, who may assign a different value to the same feature. A rational approach is beneficial to ensure the selected instrument can fulfill all the selection criteria for all interested parties, with any compromises being limited to non-critical characteristics…

Downstream Manufacturing of Gene Therapy Vectors

The goal of downstream processing is to separate the viral vector from the various impurities produced during upstream processing and to get the virus into the appropriate state for formulation and administration to patients. Viral vector batches destined for clinical use must comply to increasing regulatory standards for impurities and contaminants as these can affect product safety and potency. In addition to providing purity, purification processes need to meet production scale, which can be quite large for clinical trials and commercial applications…

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…

Headlines:

“A Centennial of Death: The Great Influenza Pandemic of 1918,” The New York Times

“Flu season is coming and flu shot season is here. I teach in a journalism institute, and when I was doing my stint as director, welcoming the new graduate students in the fall, I always used to urge they get flu shots: You’ll be wandering all over the city, I would tell them, you’ll be interviewing people, you’ll be using communal keyboards — whatever else you do, get a flu shot. And I work in a pediatric clinic, where at this time of year, we are attempting to give influenza vaccine to all our patients 6 months old and up, whatever the reason is that brought them into the clinic, from diaper rash to contraception…”

“Biogen and Eisai have revealed much-anticipated new data on Alzheimer’s drug BAN2401 that was supposed to answer some concerns about the study earlier this year—but investors don’t seem too impressed…”

“FDA Approves Xofluza: What Makes This New Flu Treatment Different,” Forbes

“Tired of hearing bad news about the flu? Well, here’s some good news. Yesterday, the U.S. Food and Drug Administration (FDA) approved a new treatment for influenza called XOFLUZA. You may think that XO stands for kisses and hugs, but XOFLUZA is anything but welcoming for the flu virus. As FDA Commissioner Scott Gottlieb, M.D. described in a statement, “this is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years…”

“France’s Sanofi SA said on Friday eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma…”

“CDC says polio-like disease is puzzling. These doctors disagree,” NBC News

“The Centers for Disease Control and Prevention says it doesn’t know what’s causing a sudden rise in cases of a frightening, polio-like condition that leaves children paralyzed or with weakened limbs…”

“Two trial wins for Roche’s immunotherapy Tecentriq,” PharmaTimes Online

“Roche’s immunotherapy Tecentriq (atezolizumab) has been shown to improve survival in lung cancer patients by almost five months in a new trial. Tecentriq plus chemotherapy boosted median overall survival to 18.6 months, compared to 13.9 months for chemotherapy alone. The combination also significantly reduced the risk of disease worsening or death compared to chemotherapy alone, with median progression-free survival at 7 months versus 5.5 months…”