This week’s headlines include: Imaging AI spots and predicts Alzheimer’s signs 6 years early in PET scan study, Hepatitis B Virus Drug Development: FDA Offers Draft Guidance, This flu season should serve as a wake-up call – we need to redouble our efforts to prevent and treat the flu, Takeda CEO confident of investor backing for $62 billion Shire deal, Lilly, NextCure Launch Cancer Immunotherapy Partnership, and GE Healthcare Collaborates to Manufacture Single-Use Consumables in China.

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

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…

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…

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:

“Using a deep learning algorithm and PET images of the brain, researchers were able to train an artificial intelligence program to spot the signs of Alzheimer’s disease more than six years ahead of a final clinical diagnosis…”

“Hepatitis B Virus Drug Development: FDA Offers Draft Guidance,” Regulatory Focus

“With an aim to assist sponsors looking to develop hepatitis B virus (HBV) treatments, the US Food and Drug Administration (FDA) on Thursday released draft guidance covering the gamut of development stages…”

“This flu season should serve as a wake-up call – we need to redouble our efforts to prevent and treat the flu,” Fox News

“Seasonal outbreaks of the flu cause thousands of deaths even in a good year, and the last flu season, 2017-2018, was a terrible one. It killed 80,000 Americans and sent 900,000 to the hospital, making it the worst influenza season in decades. Data from the Centers for Disease Control and Prevention (CDC), show how much of an outlier it was: Previously, seasonal outbreaks since 2010, had killed between 12,000 and 56,000 and caused between 140,000 and 710,000 hospitalizations…”

“Takeda CEO confident of investor backing for $62 billion Shire deal,” Reuters

“The boss of Japan’s Takeda Pharmaceutical (4502.T) said on Monday he was confident of securing investor backing for its $62 billion acquisition of London-listed Shire (SHP.L), despite some shareholders’ fears about the resulting debt burden…”

“Lilly, NextCure Launch Cancer Immunotherapy Partnership,” Genetic Engineering News

“Eli Lilly will use NextCure’s Functional, Integrated, NextCure Discovery in Immuno Oncology (FIND-IO™) platform to discover and develop cancer targets for new immuno-oncology therapies, the companies said, through a collaboration set to generate more than $40 million for the Beltsville, MD, cancer drug developer…”

“GE Healthcare Collaborates to Manufacture Single-Use Consumables in China,” R&D Magazine

“GE Healthcare is to manufacture single-use consumables for bioprocessing in Weihai, China in collaboration with Wego Pharmaceutical Co. Ltd, one of the largest healthcare technology suppliers in the country. This collaboration will decrease product delivery times for Chinese biopharmaceutical companies, enhance customer support locally, and increase their access to a wide range of standard and custom single-use products to help them bring therapeutics to patients faster…”