This week’s headlines include: WHO says 172 countries engaging with global COVID-19 vaccine plan, Catalent to make drug substance for AstraZeneca’s COVID-19 vaccine candidate, Gilead seeks U.S. approval for COVID-19 treatment remdesivir, “CureVac’s IPO Hauls In $213M as Key mRNA COVID-19 Vaccine Test Nears, Birx Stokes Hopes That Key Hospital Data Tracking Will Soon Return To CDC, For Covid-19 Vaccine, J&J Plans 60,000-Subject Pivotal Trial, J&J strikes $6.5 billion deal for autoimmune disease specialist Momenta, and Roche, Regeneron link up to develop COVID-19 antibody cocktail.

Podcasts:

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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

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

Optimized Chemically Defined HEK293t Media for Viral Vector Production Provides High Performance, Consistency and Safety

In this podcast, we talked with Thierry Cournez Vice President, BioReliance® End-to-End Solutions, MilliporeSigma. We discussed effective ways for emerging biotechs to collect material quickly and cost-effectively for pre-clinical and clinical studies. We also discussed managing the need to move quickly with cost and quality…

Efficient DNA Clearance Enables Better, Faster Virus Production

Efficient viral vector production is a key element for gene therapy manufacturing. To ensure the best production, special care must be taken when selecting a cell culture media formulation. Ideally, media should provide high productivity, consistency and quality of raw materials. It is also particularly important that the media supports scale up to larger manufacturing platforms. As such, I am pleased to share the following guest blog, which presents a chemically defined media optimized for viral vector production in HEK293t cells. The article discusses the manufacturing process behind virus-based cell and gene manufacturing and how a novel complete media was developed to address scalability, raw materials, bioreactor compatibility, and regulatory compliance…

Practical sustainable processing of post-use plastics in an increasingly single-use biomanufacturing environment

The benefits of single-use technologies in biomanufacturing are undeniable. Single-use products minimize operational risk, personnel requirements and validation activities. They also reduce utilities and water cost in cleaning and sterilization, as well as batch changeover time. This last factor is particularly valuable in pilot and small-scale manufacturing where frequent changeover is often necessary. And, as more personalized products become approved, we will no doubt be seeing even smaller manufacturing lots become an increasing priority…

Best Practices for Rapid High Titer Protein Expression

Recombinant protein expression is critical to research, biotherapeutic drug discovery and structural studies. Choosing the right protein expression system is key and the specific requirements of each application should be carefully considered. For instance, protein solubility, functionality, time to material, and required yield are often important considerations when selecting expression method…

Cool Tool: Fit-for-purpose Cell Therapy Bioprocessing Platform – MilliporeSigma ekko™ System

Cell and gene therapies require innovative processing technologies to meet the demands of moving from research into clinical and commercial manufacturing. Technologies must be designed to increase safety, efficiency and provide cost effective solution. The ekko™ acoustic cell processing system by MilliporeSigma provides a robust platform for cell processing that advances current methods for the concentrate-wash step and a number of other applications. This innovative technology delivers a closed and automated process, thereby increasing efficiency and reducing risk of contamination…

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:

“WHO says 172 countries engaging with global COVID-19 vaccine plan,” Reuters

“Some 172 countries are engaging with the WHO-led COVAX plan designed to ensure equitable access to COVID-19 vaccines, the World Health Organization said on Monday, but more funding is urgently needed and countries should now make binding commitments…”

“Catalent to make drug substance for AstraZeneca’s COVID-19 vaccine candidate,” Reuters

“The US Food and Drug Administration (FDA) on Monday finalized its guidance on marketing status notifications for new and generic drugs, clarifying its expectations for application holders required to submit marketing status notifications when their products are withdrawn from sale or are not available for sale…”

“CureVac’s IPO Hauls In $213M as Key mRNA COVID-19 Vaccine Test Nears,” Xconomy

“CureVac is playing catch-up to its messenger RNA (mRNA) peers in the race to develop a COVID-19 vaccine, but the company contends its technology could offer dosing advantages, and it now has $213 million in IPO cash to fund the human tests that could support that claim…”

“Birx Stokes Hopes That Key Hospital Data Tracking Will Soon Return To CDC,” NPR

“The U.S. Centers for Disease Control and Prevention is working “to build a revolutionary new data system” for COVID-19 hospital data collection that the CDC will run upon completion, according to Dr. Deborah Birx of the White House Coronavirus Task Force…”

“For Covid-19 Vaccine, J&J Plans 60,000-Subject Pivotal Trial,” The Wall Street Journal

“Johnson & Johnson JNJ 0.45% plans to launch by late September what could become the largest clinical trial of a coronavirus vaccine to date, enlisting up to 60,000 people world-wide to test whether its experimental shot safely protects from Covid-19…”

“J&J strikes $6.5 billion deal for autoimmune disease specialist Momenta,” Reuters

“Johnson & Johnson agreed to buy Momenta Pharmaceuticals Inc for about $6.5 billion on Wednesday, to bolster its portfolio of drugs for hard-to-treat autoimmune diseases…”

“Roche, Regeneron link up to develop COVID-19 antibody cocktail,” Reuters

“Roche (ROG.S) is adding its manufacturing muscle and global development expertise to Regeneron’s (REGN.O) bid to create an antibody cocktail for COVID-19 that the Swiss and U.S. companies hope can be used to slow the pandemic…”