This week’s headlines include: EU to enter contract talks with J&J over 200 million doses of potential COVID-19 vaccine, Marketing status notifications: FDA fills in details in final guidance, Gilead seeks U.S. approval for COVID-19 treatment remdesivir, Health Experts to F.D.A.: Make Your Vaccine Deliberations Public, Vaccine for COVID-19 will need outside expert review, U.S. regulator says, U.S. FDA approves GlaxoSmithKline’s blood cancer drug, and NIH launches clinical trials for COVID-19 monoclonal antibody treatment.

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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:

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…

Balancing Risk, Cost and Speed During Clinical Development While Still Maintaining Quality

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…

Media Optimization Strategies for Modifying Monoclonal Antibody Quality Attributes

Cell culture media optimization continues to play a critical role in both improving titers and providing a mechanism for modifying monoclonal antibody (mAb) quality attributes. Furthermore supplements and trace contaminants in the media can have dramatic effects, both positive and negative, on productivity, growth and protein quality. This highlights the importance of identifying media components that drive both productivity and desired quality profiles to select the best media formulation for each monoclonal antibody product…

The Dos and Don’ts of Cryopreservation

We recently concluded our Ask the Expert session on The Dos and Don’ts of Cryopreservation. Cryopreservation is an integral activity in most cell culture labs. Cryopreservation permits the storage and keeping of cells, tissues, and 3D systems like organoids, for future use. How cryopreservation is managed, the materials used and equipment employed can greatly impact its success. For instance, if cells are frozen too quickly ice crystals can form causing membrane damage and cell death. Thus, successful cryopreservation requires thoughtful consideration of several key items, including cryoprotective agent selection, contamination testing, storage vessels, and cooling rate, just to name a few. With so many things to consider, it is great to have expert help at hand to answer questions about the dos and don’ts of cryopreservation. For this Ask the Expert Session, we assembled a team of experts to answer questions on cryopreservation. Experts discussed freeze/thaw troubleshooting, best practice protocols, cell therapy applications and imaging considerations. In addition, vessel selection and DMSO use was also covered…

Single-Step Cloning Strategy Speeds Timeline for Novel Vaccine Candidates

With the emergence of Covid-19 this year and the threat of other novel viruses looming on the horizon, now more than ever we need fast, efficient methods for generating novel vaccine candidates. These new methods could be developed as new technologies, rethinking existing technologies, or combining existing technologies in a new way. I am pleased to share the following guest blog, which presents a method developed by GSK for single-step cloning to accelerate the novel vaccine development timeline. The approach combines existing technologies to shorten the cloning process for CHO cells to a single-step…

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:

“EU to enter contract talks with J&J over 200 million doses of potential COVID-19 vaccine,” Reuters

“The European Commission has concluded exploratory talks with Johnson & Johnson to buy 200 million doses of a potential COVID-19 vaccine, the EU executive and the U.S. pharmaceutical company said on Thursday…”

“Marketing status notifications: FDA fills in details in final guidance,” Regulatory Focus

“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…”

“Gilead seeks U.S. approval for COVID-19 treatment remdesivir,” Reuters

“Gilead Sciences Inc (GILD.O) has filed an application with the U.S. Food and Drug Administration seeking full approval for remdesivir, its experimental COVID-19 drug currently used under emergency authorization, the drugmaker said on Monday…”

“Health Experts to F.D.A.: Make Your Vaccine Deliberations Public,” The New York Times

“A letter signed by nearly 400 health experts asked the agency to use its vaccine advisory panel when reviewing data on coronavirus trials…”

“Vaccine for COVID-19 will need outside expert review, U.S. regulator says,” Reuters

“The United States will need to have independent experts review COVID-19 vaccine candidates before approval, the country’s top drug regulator said on Friday, offering reassurance that his agency would not cut corners in the race to roll out a vaccine. U.S. Food and Drug Administration Commissioner Stephen Hahn said COVID-19 vaccine candidates will be reviewed according to established legal and regulatory standards for medical products, including by an outside advisory committee…”

“U.S. FDA approves GlaxoSmithKline’s blood cancer drug,” Reuters

“The U.S. Food and Drug Administration on Wednesday approved GlaxoSmithKline’s experimental treatment for a common form of blood cancer. GSK’s belantamab mafodotin, or BLENREP, was approved for treating adults with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, the drugmaker said in a statement…”

“NIH launches clinical trials for COVID-19 monoclonal antibody treatment,” NBC News

“The National Institutes of Health announced the start of two clinical trials for a potential coronavirus treatment called monoclonal antibodies. Two treatments — remdesivir and dexamethasone — have been shown to help severely ill COVID-19 patients, but this would be the first potential drug to help patients early in the disease…”