This week’s headlines include: Gilead Sciences Places $120M Bet on a Jounce Therapeutics Cancer Drug, U.S. Won’t Join Global Coronavirus Vaccine Effort Because It’s Led By The WHO, Federal panel lays out initial priorities for COVID-19 vaccine distribution, Cats point the way to potential COVID-19 remedies, GSK, partner Vir join race to find COVID-19 antibody treatment, FDA approves expanded emergency use of remdesivir in moderate COVID-19 patients, and In ‘milestone,’ FDA OKs simple, accurate coronavirus test that could cost just $5.

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

Virtual Symposium:

Approaches and tools for maximizing success on the journey from discovery to the clinic

A one-day Biocom | Lonza Biologics virtual symposium (West)

September 15, 2020 – 8:00-2:30 PDT

Gain insight and discuss the challenges of early stage biopharmaceutical development

Biocom and Lonza Biologics are hosting a complimentary virtual symposium to gain insight from experts in the different approaches and techniques to successfully progress therapeutic candidates from discovery to the clinic. Enjoy updates on enhancements to new and established technologies enabling translational research. The day includes talks from industry experts, local companies and technical specialists from Lonza.

Register Here

Webinar:

Better Media, Better Outcomes

September 15th at 10am PST / 1pm EST

Hear all about what is really in your cell culture media and why it matters. You will leave with an understanding of all the variables within your media and why controlling them is imperative to the outcomes of your research. This webinar is perfect for anyone who uses cell culture media and wants better experimental outcomes.

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

ExpiSf™ Baculovirus Expression System Demonstrates High Yield Protein and Viral Vector Production from Micro to Large Scale

Effectual protein and viral vector production requires selection of a versatile and highly productive expression system. The insect based Baculovirus Expression Vector System (BEVS) has shown its utility in large-scale production of both proteins and viral vectors. A recent poster, Scalable protein and AAV production in the ExpiSf™ Expression System, demonstrates the use of the Gibco™ ExpiSf™ Expression System for high-yield production of proteins and viral particles with consistent performance using a fast, streamlined workflow. The system demonstrates scalability for production in stirred tank, rocking motion, and microbioreactors. Optimal bioprocessing parameters and protocols to enable high quality process development for production of targets of interest are described…

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 – 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 Sciences Places $120M Bet on a Jounce Therapeutics Cancer Drug, Xconomy

“Gilead Sciences is opening up its checkbook yet again to add another cancer therapy to its pipeline, this time committing $120 million to Jounce Therapeutics for rights to an antibody drug approaching clinical testing. The Jounce (NASDAQ: JNCE) drug, JTX-1811, is intended to selectively deplete regulatory T cells—the type of immune cells that suppress the immune response. Cambridge, MA-based Jounce has said that therapies targeting regulatory T cells may help address cancers that don’t respond to currently approved immunotherapies…”

“U.S. Won’t Join Global Coronavirus Vaccine Effort Because It’s Led By The WHO,” Forbes

“The U.S. announced Tuesday that it would not join an international coalition to find and distribute a Covid-19 vaccine worldwide due to the group’s association with the World Health Organization, the latest sign of the Trump administration withdrawing the country from the international health community’s response to the pandemic over political concerns…”

“Federal panel lays out initial priorities for COVID-19 vaccine distribution,” The Hill

“Initial doses of a COVID-19 vaccine should go to front-line health workers, first responders and people at serious risk for infection, according to new draft guidelines released Tuesday by a federal advisory panel. The draft guidelines were developed by the National Academies of Sciences, Engineering, and Medicine to help U.S. officials plan for an equitable allocation of an eventual vaccine…”

“Cats point the way to potential COVID-19 remedies,” Fierce Biotech

“Last week, Gilead Sciences said it would test its COVID-19 drug remdesivir against a related compound in its library called GS-441524 in animal trials, after facing scrutiny over the latter drug, which has been used for years to treat feline infectious peritonitis (FIP) despite not being licensed for that use. Now, another California biotech, Anivive Lifesciences, is working on a COVID-19 antiviral drug that’s inspired by cats, and it has new preclinical research findings to back up the project…”

“GSK, partner Vir join race to find COVID-19 antibody treatment,” Reuters

“GlaxoSmithKline and partner Vir Biotechnology have started testing their experimental antibody on early-stage COVID-19 patients, entering the race to find a winner in a promising class of antiviral drugs to combat the pandemic…”

“FDA approves expanded emergency use of remdesivir in moderate COVID-19 patients,” Reuters

“Gilead Inc said on Friday the U.S. Food and Drug Administration has authorized expanded emergency use for its experimental antiviral COVID-19 treatment, remdesivir. The drug can now be used to treat all hospitalized patients with COVID-19, in addition to patients with a severe form of the illness…”

“In ‘milestone,’ FDA OKs simple, accurate coronavirus test that could cost just $5,” Science

“Coronavirus testing is set to get faster. Yesterday, the U.S. Food and Drug Administration (FDA) gave an emergency use authorization to Abbott Laboratories for a 15-minute test that should ease bottlenecks. Analogous to tests that detect HIV and influenza, the new diagnostic detects viral proteins, or antigens, that are unique to SARS-CoV-2, the virus that causes COVID-19. Unlike conventional coronavirus diagnostics, Abbott’s test requires no specialized laboratory equipment. Abbott says the new assay will cost $5, and the company intends to produce tens of millions of the tests in September and 50 million in October. By providing near–real-time answers on whether someone is infected, the novel test promises to let infected individuals quickly learn that they should isolate themselves and prevent further spread of the virus…”