This week’s headlines include: Lawmakers press CDC for plan on distributing COVID-19 vaccine, BioNTech’s mRNA COVID-19 Vaccine Shows Early Signs of Sparking Immunity, U.S. FDA comes out with guidance for COVID-19 vaccine approval, U.S. withdrawal from WHO threatens to leave it ‘flying blind’ on flu vaccines, Roche’s combo therapy for advanced breast cancer gets U.S. FDA approval, AstraZeneca, Moderna ahead in COVID-19 vaccine race: WHO, and FDA finalizes bacterial pneumonia drug development guidances.

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:

Covid-19 Resources:

As the SARS-CoV-2 pandemic has spread around the world, scientists, doctors, clinicians and biopharmaceutical companies are working hard 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 and vaccines are being researched and tested for rapid delivery. Due to the magnitude of the effort by all involved, it is difficult to keep track of the numerous therapeutic, discovery and manufacturing related resources available.

We have created this page to house articles that Cell Culture Dish publishes related to Covid-19 and links to resources from suppliers who have gathered information, technologies and techniques that could be helpful for those engaged in Covid-19 related research and manufacturing. Covid-19 Resources

Webinars:

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

COVID-19 Therapeutics in Clinical Trials:  The Immunomodulators

We scanned clinicaltrials.gov and found dozens of medications, world-wide, that have been in trial, currently are in trial, or are soliciting applicants for study.  These medications include a include antivirals, antiviral cell mediators, immunomodulators, and other therapeutic classes.  They are being evaluated singly, or in combinations, and usually across multiple clinical sites…

A Look Towards the Future of 3D Cell Culture – A panel discussion

Researchers have used 2D cell culture since the early 1900s, but we know that growing cells on planar surfaces have some drawbacks. Cells grown in vitro in 2D space don’t behave like cells found in vivo. They lack critical cell-cell and cell-matrix interactions that drive their form, function and response to external stimuli. This limits their prognostic capabilities. More recently, 3D cell culture techniques have become popular because the cell morphology, interactions and tissue-specific architecture more closely resembles that of in vivo tissues. Spheroids, organoids and more complex 3D tissue systems, such as ‘organ-on-a-chip’ are examples of 3D cultures used by researchers to model native tissues…

Cool Tool – Next Generation Bioprocess Controller SciVario® twin Provides Flexible Solution to Address Current and Future Needs

Process development has always been both a critical, and resource intensive part of biomanufacturing. Thus, the industry is routinely looking for more efficient ways to improve the process. Recently, a modern digital biomanufacturing approach has been gaining acceptance. This approach involves acquiring more process understanding, monitoring and analytics than ever before and is constantly evolving to incorporate new technologies and demands…

Ask the Expert – Bringing 3D models into a High Throughput Environment

Since increasing throughput of any cell culture technique is full of unique challenges, we have assembled a team of experts to answer your questions on how to increase throughput for 3D cell culture models…

Organoid Models: Getting Started and Culture Tips

An organoid is defined as an in vitro 3D cellular cluster derived from primary tissue (lineage restricted adult stem cells), embryonic stem cells (ESCs), or induced pluripotent stem cells (iPSCs), capable of self-renewal, self-organization, showing similar organ functionality as the tissue of origin. Their similarity in composition and function to or-gans in vivo makes them invaluable 3D models to study organogenesis, disease modeling, and patient-specific therapies. Organoids recapitulate a large number of biological parameters including the spatial organization of heterogeneous tissue-specific cells, cell-cell interactions, cell-matrix interactions, and certain in vivo physiological functions generated by tissue-specific cells within the organoid¹. Organoids bridge a gap between 2D and animal model systems by providing a stable system amenable to extended cultivation and manipulation. As such, researchers have created physiologically relevant organoid models for many organs. That said, working with organoids is not without its challenges. High quality cell culture tools are important to ensuring success when researchers are looking to incorporate organoids into cell culture workflows…

Ask the Expert – How to minimize contamination risk and protect your cultures

With contamination lurking everywhere, it may feel daunting to think about protecting precious cultures. Not to worry, help is here! For this Ask the Expert Session, we have assembled a team of experts to answer your questions on contamination and minimizing risk…

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:

“Lawmakers press CDC for plan on distributing COVID-19 vaccine,” FierceHealthcare

Several senators pressed the Trump administration on when a plan for how to distribute a vaccine for COVID-19 will arrive and to build confidence among the public to get them to take it. The Senate Health, Education, Labor and Pensions Committee held a hearing Tuesday with members of the coronavirus task force on how to safely return to work and school. Several lawmakers were concerned about the lack of a comprehensive plan on vaccines from the Centers for Disease Control and Prevention (CDC)…

“BioNTech’s mRNA COVID-19 Vaccine Shows Early Signs of Sparking Immunity,” Xconomy

A BioNTech messenger RNA vaccine candidate for COVID-19 has shown in a small study that it can elicit an immune response to the novel coronavirus. The 45-patient US study tested three doses of the experimental mRNA vaccine, BN162b1, along with a placebo. Early results now available show higher levels of the antibodies hoped to neutralize the virus compared to what has been observed in patients who recovered from COVID-19. No serious safety problems were reported in the Phase 1/2 clinical trial results announced Wednesday, which were also published in a preprint, a research paper that has not yet been peer reviewed…

“U.S. FDA comes out with guidance for COVID-19 vaccine approval,” Reuters

The U.S. Food and Drug Administration on Tuesday released guidance for approving a coronavirus vaccine, saying the vaccine has to prevent or decrease disease severity in at least 50% of people who are inoculated. More than 100 vaccines are being tested worldwide against the virus, which has claimed over 126,100 lives in the United States, according to a Reuters tally…

“U.S. withdrawal from WHO threatens to leave it ‘flying blind’ on flu vaccines,” STAT

Twice a year, influenza experts from 10 institutions around the world meet at the World Health Organization’s Geneva headquarters to pore over mounds of data. At the end of the weeklong meetings, they make decisions that affect people around the world: namely, which variants of the flu virus should be used for vaccinations the following season. While the selections don’t always hit the mark — influenza is notoriously hard to predict — it’s the best process health officials have to keep flu vaccines up to date and try to protect people from the annual scourge…

“Roche’s combo therapy for advanced breast cancer gets U.S. FDA approval,” Reuters

The U.S. Food and Drug Administration on Monday approved Roche Holding AG’s combination therapy for a form of advanced breast cancer that has spread to other parts of the body. The therapy, Phesgo, was approved for patients with HER2-positive breast cancer and comes with a boxed warning flagging risks of potential heart failure, fetal harm and lung toxicity…

“AstraZeneca, Moderna ahead in COVID-19 vaccine race: WHO,” Reuters

AstraZeneca’s (AZN.L) experimental COVID-19 vaccine is probably the world’s leading candidate and most advanced in terms of development, the World Health Organization’s (WHO) chief scientist said on Friday…

“FDA finalizes bacterial pneumonia drug development guidances,” Regulatory Focus

The US Food and Drug Administration (FDA) on Wednesday finalized two guidances on developing drugs to treat community-acquired or hospital-acquired and ventilator-associated bacterial pneumonia. Both guidances offer recommendations to sponsors on the development of drugs to treat bacterial pneumonia acquired in different settings and feature input on nonclinical development, trial population, efficacy trial considerations and other issues including pharmacokinetic/pharmacodynamic and labeling considerations…