The Dish’s Weekly Biotechnology News Wrap Up – May 29, 2020

This week’s headlines include: Coronavirus discoveries can come along faster with adaptive clinical trials, South Africa BCG booster trials seek low-cost weapon against COVID-19, Will government mandate COVID-19 vaccinations?, Tiny robots can travel through rushing blood to deliver drugs, U.S. secures 300 million doses of potential AstraZeneca COVID-19 vaccine, Federal Scientists Finally Publish Remdesivir Data, Merck to buy Austrian vaccine maker as it jumps into COVID-19 race, and U.S.’ Regeneron to buy back $5 billion stake held by Sanofi.

Podcasts:

Check out our podcast channel. We have over 40 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:
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Webinars:

Harnessing the Power of Protein Expression Systems in Vaccine Development

DATE:  June 2, 2020
TIME:   7:00am PT, 10:00am ET
In just a few months COVID-19 has risen from a regional crisis to a global threat, and drug makers are now scrambling to develop vaccines aimed at thwarting a pandemic. To meet this urgent and life-threatening situation, vaccine developers are actively seeking the most efficient and robust production platforms to accelerate development timelines. Throughput, productivity, and scalability of the expression platform as well as the availability of well-documented production cell lines are key selection criteria when initiating a vaccine development campaign under such urgent circumstances. To this end, the Gibco Expi Expression Systems are complete platforms that can accelerate vaccine development by enabling rapid, high-yield, and scalable production of proteins, viral antigens and viral-like particles from mammalian (ExpiCHO and Expi293) and insect (ExpiSf) cells. By providing flexible and highly productive expression systems for three different cell hosts that employ optimized and chemically defined components, the Expi systems support every stage of vaccine development. This unified, end-to-end approach reduces key product quality risks during development as one can use the same cell line from research to large-scale production while streamlining process development by utilizing integrated reagents for unmatched performance.
Learning Objectives:
  • Understand how to accelerate vaccine development timelines
  • Discover new technologies for rapid, high-yield, and scalable production of proteins, viral antigens, and viral-like particles

 

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

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COVID-19 Therapeutics in Clinical Trials:  The Antivirals

As the SARS-CoV-2 pandemic spreads around the world in early 2020, scientists, doctors, and clinicians are rushing to find effective therapies for COVID-19 disease.  Approved and investigational medications with a spectrum of activities are being examined as to whether they can be repurposed for COVID-19. Due to the magnitude of the effort by the medical community, it is difficult to keep track of the numerous therapeutic approaches. We scanned clinicaltrials.gov and found roughly 50 medications, world-wide, that have been in trial, currently are in trial, or are soliciting applicants for study.  The medications include a broad array of activities which include antivirals, antiviral cell mediators, immunomodulators, and others. They are being evaluated singly, or in combinations, and usually across multiple clinical sites…

Bi-Specific Antibodies – The development, manufacture and promise of these cutting-edge therapeutics

In this podcast, we conducted a panel discussion with experts from Selexis and KBI Biopharma on bi-specific antibodies. We examined bi-specific antibody development and manufacturing, including current challenges and key solutions. We also discussed the promise of these cutting-edge therapeutics and their future in medicine…

Rapid At-line Media Analyzer Speeds Process Development by Eliminating Analytics Bottleneck

In this podcast, we talked with Dr. Glenn Harris, Director of Integrated Life Sciences Platforms at 908 Devices, about the benefits and challenges of implementing rapid media analysis in process development, including the bottleneck created by outsourcing samples to core labs. We also discussed an easy to implement, benchtop media analyzer that permits comprehensive media analysis in real-time, thus speeding process development efforts…

Best Practices for Being Productive and Staying Connected While Out of the Lab

Working from home can be very challenging, particularly if your work normally takes place in a lab. We were fortunate to have six cell culture researchers, who are part of Gibco’s Cell Culture Heroes program, share their experiences and best practices for being productive, staying connected, and keeping a healthy outlook while out of the lab…

Non-Animal Origin cell culture supplements and manufacturing aids for biologics manufacturing

In this podcast, we talked with Dr. Tobias Hertzig, Regulatory Affairs Manager and Dr. Ulrich Tillmann, Global Product Manager, Supplements and Manufacturing Aids both representing Merck KGaA, Darmstadt, Germany. We discussed non-animal origin cell culture media supplements, including regulatory advantages, performance metrics and their use in biologics manufacturing…


The Down Stream Column

Cool Tool – Cellulose Fiber-based Chromatography Increases Flexibility and Throughput in Antibody Purification

Recent industry initiatives have put increased emphasis on improving the flexibility and throughput of biomanufacturing processes. To achieve this, new technologies are required that permit faster process times and increased flexibility for a variety of manufacturing scenarios including smaller batch sizes and multi-product facilities. One critical aspect of the biomanufacturing process is downstream chromatography purification and this can often be a time and resource intensive step…

Innovative Single-Use Freeze and Thaw Platform for Bulk Drug Substance

Successful bulk drug substance freeze and thaw is a critical aspect of biologics manufacturing. It is also time consuming and labor intensive. Historically, cryovessels have been the most common technology used for freeze and thaw due to their durability and scalability. However, cryovessels require extensive cleaning processes and infrastructure and labor to maintain them. These challenges, led companies to look for single-use alternatives. While single-use significantly reduces cleaning requirements, they are difficult to scale due to limitations of the size of the bags. Another downside is that they can be prone to integrity issues…

Top Downstream Process Articles of 2019

Don’t miss our top articles on downstream processing for 2019! I have compiled a list of our most popular articles from 2019 in alphabetical order…

Automated Buffer Preparation – Increasing Production Capacity While Maintaining Footprint

Buffer preparation requires extensive footprint and is also resource-intensive. In fact, it is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required as production capacity increases. Thus the question exists how can buffer preparation be more efficient and not require footprint expansion. Is there a way to increase manufacturing capacity without increasing footprint and time spent on buffers? One possible solution is automating buffer preparation and I am pleased to share the following guest blog that discusses the advantages and addresses concerns about moving from manual to automated buffer preparation. I was fortunate to be able to interview the author about his article and have provided the transcript of our conversation following the guest blog…

Viral Filtration Validation Study Design – A Systematic Method for Choosing the Most Appropriate Test Approach

Viral filter validation is important to ensure the removal of viruses under the conditions seen at process scale when using scale-down models. When designing an effective study, there are key components that must be decided on. First, it is important to select a virus spike level that will allow for quantification of virus removal, without having a negative impact on the scaled down process. Second, it is important to understand how a virus prefilter will be incorporated into the study design…


Headlines:

“Coronavirus discoveries can come along faster with adaptive clinical trials,” The Los Angeles Times

As the medical profession scrambles to treat patients sick and dying from COVID-19, improvisation has become one of its most improbable — and important — tools. Could the same strategy be applied to coronavirus research, to suss out the best treatments for infected patients at a quicker pace? The federal government is counting on it. To identify the most effective COVID-19 drugs at top speed, the National Institutes of Health have embraced an approach called the adaptive clinical trial. The Adaptive COVID-19 Treatment Trial, better known to medical researchers as ACTT, has been hailed as a fast, flexible and relatively cheap way to sort through an array of drugs and provide doctors with standard treatment protocols for their patients…

“South Africa BCG booster trials seek low-cost weapon against COVID-19,” Reuters

The idea of testing the BCG vaccine in Africa against COVID-19 was bound to cause controversy, yet officials say efforts underway could, if successful, give the continent a cheap and easily deployable weapon against the virus…

“Will government mandate COVID-19 vaccinations?” The Hill

When a COVID-19 vaccine becomes available, I will be one of the first in line. But the fact is U.S. adults tend to have low vaccination rates. If the government determines that vaccinations are essential to stemming the spread of the disease, would it – could it – mandate vaccination compliance? Apparently, it can — and it might…

“Tiny robots can travel through rushing blood to deliver drugs,” New Scientist

Tiny drug-carrying robots that can move against the direction of blood flow could one day be used to deliver chemotherapy drugs directly to cancer cells. Metin Sitti at the Max Planck Institute for Intelligent Systems in Stuttgart, Germany, and his colleagues have developed tiny robots called “microrollers” that can carry cancer drugs and selectively target human breast cancer cells…

“U.S. secures 300 million doses of potential AstraZeneca COVID-19 vaccine,” Reuters

The United States has secured almost a third of the first 1 billion doses planned for AstraZeneca’s experimental COVID-19 vaccine by pledging up to $1.2 billion, as world powers scramble for medicines to get their economies back to work…

“Cytiva Teams Up with Takara Bio to Work on COVID-19 Vaccine Candidate,” Genetic Engineering News

Cytiva, formerly part of GE Healthcare Life Sciences, agreed to collaborate with Takara Bio to manufacture a DNA vaccine candidate for COVID-19. Along with Osaka University and AnGes, Takara Bio is working on a plasmid vaccine to generate the SARS-CoV-2 protein that would become an antigen, and help people develop immunity against the virus…

Nearly a month after federal scientists claimed that an experimental drug had helped patients severely ill with the coronavirus, the research has been published. The drug, remdesivir, was quickly authorized by the Food and Drug Administration for treatment of coronavirus patients, and hospitals rushed to obtain supplies…

“Merck to buy Austrian vaccine maker as it jumps into COVID-19 race,” Reuters

Merck & Co Inc (MRK.N), which has largely kept to the sidelines of the race for COVID-19 treatments, said it was buying Austrian vaccine maker Themis Bioscience and would collaborate with research nonprofit IAVI to develop two separate vaccines…

“U.S.’ Regeneron to buy back $5 billion stake held by Sanofi,” Reuters

U.S. company Regeneron Pharmaceuticals said it had agreed to repurchase approximately $5 billion of its shares directly from French drugmaker Sanofi. Sanofi, which holds about 23.2 million Regeneron shares, said separately it intended to sell its equity investment, and that the move would not change ongoing collaboration between the two groups…