This week’s headlines include: FDA says it will consider approval of first dengue vaccine, despite controversy, Novartis, Pfizer join forces on potentially lucrative fatty liver disease, How to Turbocharge Flu Protection (Llamas Required), Novartis dumps 20% of programs following pipeline review, To Boost Cancer Pipeline, Gilead Bets at Least $50M on Startup Tango, and Patent awarded for DNA-targeting complex at heart of CRISPR-Cas9 gene editing.

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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…

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….

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…

Headlines:

“The Food and Drug Administration has agreed to consider Sanofi Pasteur’s application for Dengvaxia, the world’s first licensed vaccine that protects against dengue but one that brings with it considerable controversy and concern. The company announced Tuesday that it has received notice the regulatory agency will give the vaccine’s file a priority review, which means a decision must be rendered within six months….”

“Novartis AG and Pfizer Inc are teaming up to develop treatments for a liver disease many drug companies believe will become a hugely lucrative market, as it is tied to the obesity and diabetes epidemics…”

“How to Turbocharge Flu Protection (Llamas Required),” The New York Times

“The oncoming flu season has claimed its first lives, among them a child in Florida who had not gotten a flu shot. This year’s vaccine significantly reduces the odds of getting sick — and you should get one now if you haven’t already — but it’s far from perfect. For one thing, its effectiveness fluctuates from year to year. At best, the vaccine may reduce the risk of illness by about 60 percent. Last year, during one of the worst flu epidemics in recent memory, that figure was just 40 percent…”

“Jay Bradner, M.D., has revealed that Novartis has scrapped one-fifth of its drug programs. The cull is designed to limit Novartis’ pipeline to potentially transformative therapies that fit with the company’s ambitions…”

“To Boost Cancer Pipeline, Gilead Bets at Least $50M on Startup Tango,” Xconomy

“Gilead Sciences is paying tiny Tango Therapeutics $50 million to tap into the startup’s cancer drug program, adding to what has been so far an expensive, but not yet lucrative, foray into cancer immunotherapy for Gilead…”

“Patent awarded for DNA-targeting complex at heart of CRISPR-Cas9 gene editing,” Berkeley News

“The University of California announced today that the U.S. Patent and Trademark Office has granted U.S. Patent Number 10,113,167, covering unique RNA guides that, when combined with the Cas9 protein, are effective at homing in on and editing genes. These RNA/protein combinations act like precision-targeted gene-editing scissors…”