This week’s headlines include: Gilead’s remdesivir prevents lung damage in COVID-19 study on monkeys, FDA names Farley director of the Office of Infectious Diseases, J&J’s Janssen Speeds Up Planned Launch of COVID-19 Vaccine Trial, South Korea’s Daewoong Pharmaceutical says anti-parasitic drug effective against coronavirus in animal tests, and Biotechnology In the Time of COVID-19: Past, Present, and Future.

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:

Webinars:

COVID-19 Serology Assays and Cell Therapy Strategies

June 30, 2020, 10:00 am PDT, 1:00 pm EDT

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

Spheroid Models: Getting Started and Culture Tips

It has been well established that three-dimensional (3D) cell culture is better at replicating the physiological interactions between cells and their environment than traditional two-dimensional (2D) cell culture. In fact, many types of mammalian cells have the ability to self-aggregate into 3D aggregates called cellular spheroids when cultured in suspension or in a nonadherent environment. Common examples of spheroids include embryoid bodies, mammospheres, hepatospheres, and neurospheres. Perhaps the most widely utilized spheroid model is the multicellular spheroid model (MCTS) formed from cancer cells, which is commonly used as avascular tumor models to gain mechanistic insight into cancer invasion and metastasis and as an anti-cancer therapeutic screening tool. The heterogeneous population of proliferating and non-proliferating cells is exposed to a gradient of oxygen emulating the physio-chemical gradients found in solid tumors, therefore, making them more predictive in vitro models than 2D cultures. Additionally, they are also relatively easy, fast, versatile, and are inexpensive enough to enable high-throughput screening, which makes them attractive models for many applications…

Cool Tool – The Addition of Allegro™ STR 500 Enables Seamless Single-Use Bioreactor Scalability from 50 to 2,000 L

Large-scale biomanufacturing frequently relies on single-use bioreactor systems for efficient manufacturing and scale-up. However, one challenge has been predictable scale-up from process scale bioreactors to larger manufacturing volumes. Pall has met this challenge with the Allegro STR bioreactor product line, which includes 50, 200, 1000, 2000 and the new 500 L bioreactor. The consistency in design, engineering and performance across all volumes enables predictable scale-up. In addition, the Allegro STR 500 bioreactor system leverages the usability and process assurance features seen in the entire Allegro STR bioreactor product range…

Multistem – A Stable, Off-the Shelf Regenerative Medicine Has Demonstrated Promise in Treating Patients with Acute Respiratory Distress Syndrome or ARDS

In this podcast and accompanying article, we talked with Dr. Gil Van Bokkelen, Chairman and CEO, Athersys about recent clinical breakthroughs in regenerative medicine and manufacturing challenges. We also discussed Multistem and how it has been demonstrated to help patients with ARDS (Acute Respiratory Distress Syndrome)…

3D Model Systems: Spheroids, Organoid and Tissue Model Systems

Here, we look to demystify Spheroid and Organoids and discuss the distinct differences between them and their utility in scientific research as well as more advanced 3D tissue model systems like organ-on-a-chip technology…

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…

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:

“Gilead’s remdesivir prevents lung damage in COVID-19 study on monkeys,” Reuters

Gilead Sciences Inc’s (GILD.O) antiviral drug remdesivir prevented lung disease in macaque monkeys infected with the new coronavirus, according to a study published in the journal Nature on Tuesday…

“FDA names Farley director of the Office of Infectious Diseases,” Regulatory Focus

John Farley has been appointed director of the Office of Infectious Diseases (OID) in the Center for Drug Evaluation and Research’s Office of New Drugs (OND). He had been acting director of OID since Edward Cox left the agency in August 2019 to join Regeneron…

“J&J’s Janssen Speeds Up Planned Launch of COVID-19 Vaccine Trial,” Genetic Engineering News

Johnson & Johnson (J&J) said today that its Janssen Pharmaceutical Companies will speed up by two months the start of its planned Phase I/IIa clinical trial assessing its lead COVID-19 vaccine candidate, with the first-in-human study of Ad26.COV2-S, recombinant, to be moved from September to the second half of July…

“South Korea’s Daewoong Pharmaceutical says anti-parasitic drug effective against coronavirus in animal tests,” Reuters

South Korea’s Daewoong Pharmaceutical (069620.KS) said its anti-parasitic drug niclosamide had eliminated the novel coronavirus from animals’ lungs during testing. Drugmakers worldwide are rushing to develop treatments for the illness caused by the new coronavirus, which has killed more than 400,000 globally since it first emerged late last year in China…

“Biotechnology In the Time of COVID-19: Past, Present, and Future,” Forbes

While there are many biotechnology industry organizations worldwide, the most prominent one is called the Biotechnology Innovation Organization (BIO). In addition to working with numerous stakeholders, including the government, to promote industry growth and innovation, education, and industry analytics, it runs the world’s largest conference series, also called BIO. These conferences transpire in many different US cities, as well as around the world; however, as with many other events, this year’s conference will be going digital. This will be one of the largest online conference experiments ever, as the highlight of the meeting is partnering…