This week’s headlines include: U.S. COVID-19 vaccine program to start manufacturing by late summer, says U.S. official, Roche, Blueprint Medicines Team Up Again in $775M RET Cancer Drug Pact, Pfizer, BioNTech’s coronavirus vaccine candidates get FDA’s ‘fast track’ status, FDA updates COVID-19 therapeutics website, Pfizer CEO Albert Bourla Raises Expectations That the Pharmaceutical Giant Can Deliver a COVID-19 Vaccine by Fall, Want to defeat COVID-19? Deliver a 70% effective vaccine—and get 70% of people to take it, FDA official says, Orgenesis to Collaborate with Educell to Conduct Clinical Validation of Cell Therapies Using Orgenesis’ Proprietary POCare Technologies for the Generation and Expansion of T-Cells, and Biogen boosts gene therapy strategy with Harvard pact focused on inherited eye disease.

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:

Upcoming Ask the Expert Session Next Week: 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 have assembled a team of experts to answer your questions on cryopreservation. Please submit questions starting Monday!

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

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…

Scalable High Yield System for Mass Culture of Attachment-Dependent Cells

As increasing numbers of cell and gene therapies progress from research to clinical trials and on to commercialization, the need for efficient manufacture of high numbers of cells is critical. Many of the cells used in these therapies are attachment-dependent, which means that they need a surface on which to grow and expand. This need for attachment makes growing them in large numbers more challenging, as adherent systems do not traditionally scale up to the high volumes that can be achieved with suspension systems. However, suspension systems typically require more time and resources to develop a successful process…

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…

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:

“U.S. COVID-19 vaccine program to start manufacturing by late summer, says U.S. official,” Reuters

Drugmakers partnered with the U.S. government are on track to begin actively manufacturing a vaccine for COVID-19 by the end of the summer, a senior administration official said on Monday…

“Roche, Blueprint Medicines Team Up Again in $775M RET Cancer Drug Pact,” Xconomy

A Blueprint Medicines cancer drug candidate currently under FDA review will have the marketing muscle of Roche behind it if it wins regulatory approval. The two companies are partnering on the drug, pralsetinib, a targeted cancer therapy developed for lung and thyroid cancers characterized by abnormalities in a gene called RET. According to deal terms announced Tuesday, the companies will jointly commercialize the pill in the US. Roche gains rights to sell the drug globally, except for China. The Swiss pharmaceutical giant agreed to pay Cambridge, MA-based Blueprint (NASDAQ: BPMC) $675 million up front for those rights. It’s also making a $100 million equity investment in its partner at $96.57 per share, a nearly 26 percent premium to Monday’s closing stock price…

“Pfizer, BioNTech’s coronavirus vaccine candidates get FDA’s ‘fast track’ status,” Reuters

Pfizer Inc an”d partner BioNTech SE said on Monday two of their experimental coronavirus vaccines received ‘fast track’ designation from the U.S. health agency, speeding up the regulatory review process…

“FDA updates COVID-19 therapeutics website,” Regulatory Focus

The US Food and Drug Administration (FDA) has to date reviewed over 230 trials of potential therapeutics to treat the novel coronavirus (COVID-19), according to a blog post by FDA commissioner Stephen Hahn, MD and colleagues. Over 510 COVID-19-directed drug development programs have reached the planning stage…

“Pfizer CEO Albert Bourla Raises Expectations That the Pharmaceutical Giant Can Deliver a COVID-19 Vaccine by Fall,” Time

Pfizer is increasingly confident that its efforts to develop a coronavirus vaccine will be successful. In a July 7 interview with TIME, Pfizer CEO Albert Bourla said he believes that Food and Drug Administration approval could come as soon as October. On the basis of promising results in an early-stage trial released on July 1, Pfizer has dramatically increased the projections for the number of doses it will produce this year, from tens of millions to 100 million. Bourla also disclosed that the company has begun commercial talks with governments around the world about how many doses they will receive…

“Want to defeat COVID-19? Deliver a 70% effective vaccine—and get 70% of people to take it, FDA official says,” FiercePharma