This week’s headlines include: Amgen antibody shows promise in myeloma trial, gets FDA fast track, Top biotech lobbyist: Industry under ‘greater threat’ than ever before, U.K. sets out digital, data-driven plan to accelerate R&D, Microbiome Modeling Reveals How Bacteria Shape Host Fitness, Six to 8 Hours a Night May Be the Sweet Spot for Sleep, and World’s first honey bee vaccine seeks to save dying pollinators.

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

T Cell Media: A Comprehensive Guide to Key Components

With the recent surge of cellular T cell-based immunotherapies, more and more researchers are taking an interest in these specialized immune cells. Whether you are brand new to the field or an experienced immunologist, learning to work with a new cell type can often feel overwhelming. In this guide, we will explain the ins and outs of culturing T cells, so you can spend less time searching for answers and more time making discoveries…

Cell Harvesting Technologies – Which is best for your process?

Cell harvesting is a critical step in connecting upstream monoclonal antibody production with downstream purification. Selecting the best cell harvesting technology based on the characteristics of the cell culture process can be challenging. This decision is made early in process development and requires a good understanding of both the current process and the advantages/disadvantages of the various cell harvesting technologies available…

Large Scale Adenovirus Production for Gene Therapy Manufacturing

Gene therapy is one of the most promising developments in medicine. It has the potential to treat many diseases by using a gene-modifying technology to repair, replace or correct genetic damage in the body. Last year was an important year for advancing gene therapy with two pioneering Chimeric Antigen Receptor T Cell (CAR T) cell therapies for cancer approved in the US: Novartis’ Kymriah^® and Kite/Gilead’s Yescarta^® and Spark’s Luxturna^® was approved to correct a retinal disease…

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…

Monolithic Chromatography Enables Process Intensification of Virus Purification

Monoliths are unique from other forms of chromatography media for several reasons. Monolith architecture consists of highly interconnected convective channels that are distributed throughout the entire bed. The large channels are easily available for purification even for large biomolecules. This unique architecture also creates a void-less space, thus significantly reducing shear and product loss. In monoliths, the mass transport is also exclusively convective and laminar which means that all solutes flow with the current regardless of size and require only a few seconds of residence time…

Rapid Characterization of Virus Like Particles Informs Vaccine and Gene Therapy Downstream Processes

When working with viral systems, either during manufacture of viral-based vaccines or gene therapies, having the right analytics is crucial. This is particularly true when optimizing downstream processes and in characterizing product lots for purity. Information on the amount of virus like particles present, particle structure and their biological impact not only informs the manufacturing process, but also final product purity and quality. While these answers are important they are not always easy to access. The following case study demonstrates the use of the MiniTEM as a convenient analytical, direct-measurement method to characterize virus like particles (VLPs) or virus preps. While this case study focuses on influenza vaccine, it is important to note that this is just one example and that the technology could be used in many viral-based vaccine or viral vector manufacturing scenarios…

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….

Headlines:

“Amgen Inc, updating the first trial of its bispecific antibody for multiple myeloma, said on Monday seven out of 10 patients given the second-highest dose of AMG420 responded to the drug, including four with no detectable cancer…”

“Top biotech lobbyist: Industry under ‘greater threat’ than ever before,” The Hill

“The top biotech industry lobbyist said his industry is “under a greater threat than it’s ever been before” as the Trump administration and Democrats in Congress set their sights on drug companies. “I’m certainly not sitting here saying we don’t have a problem; we have a problem,” said James Greenwood, the CEO of the Biotechnology Innovation Organization, the trade group that is the cousin of PhRMA, representing smaller biotech companies. “I’d say the industry is under a greater threat than it’s ever been before…”

“The U.K. government has set out how it plans to use data and digital technologies to attract clinical trials. Near-term plans include the creation of a system for assessing study feasibility and an app to connect patients to studies. U.K. plans to leverage a trove of longitudinal health data to attract life science investment predate the vote to leave the European Union, but the strategy has taken on greater importance in light of the need for the country to redefine its place in the industry. The importance of data and digital tools to the U.K.’s post-Brexit vision is evident in the government’s second deal with the life sciences sector…”

“Microbiome Modeling Reveals How Bacteria Shape Host Fitness,” Genetic Engineering News

“Researchers at the University of California, Santa Barbara say they have developed a mathematical approach to analyze and model interactions between gut bacteria in fruit flies. This method could lead to a more sophisticated understanding of the complex interactions between human gut microbes, according to the scientists whose study (“Microbiome interactions shape host fitness”) appears in PNAS…”

“Six to 8 Hours a Night May Be the Sweet Spot for Sleep,” The New York Times

“The study, in the European Heart Journal, found that compared with people who slept six to eight hours a night, those who slept eight to nine hours had a 5 percent increased risk for cardiovascular disease or death. People who slept nine to 10 hours had a 17 percent increased risk, and those who slept more than 10 hours increased their risk by 41 percent. The researchers also found a 9 percent increased risk in people who slept less than six hours, but that difference was not statistically significant…”

“World’s first honey bee vaccine seeks to save dying pollinators,” SFGate

“A growing number of honey bees die each year due to pesticides, vanishing habitats, poor nutrition and climate change, with potentially disastrous consequences for agriculture and natural diversity. Now, scientists at the University of Helsinki have developed the first edible vaccine against microbial infections, hoping to save at least some of the pollinators…”