This week’s headlines include: Biogen Alzheimer’s drug closer to approval with U.S. FDA staff backing, shares jump 40%, FDA publishes list of essential medicines, devices, Britain prepares for COVID-19 vaccine as Oxford forecasts result this year, Erbi Biosystems raises $3.8M to expand their platform of microfluidic bioprocess and bioreactor equipment, which enables ultra-high cell density and continuous processing, J&J plans to test its COVID-19 vaccine in ages 12-18 soon, UW-Madison resuming COVID-19 vaccine trial next week, and Novartis buys Vedere Bio, whose founders helped blind mice see.

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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

Upcoming Webinars:

Vaccine Production: Securing Process Quality with Flexible Manufacturing Solutions

Implementing single-use technologies in formulation and filling of vaccines
Tuesday, Nov 17 – 08:00 PST | 11:00 EST | 16:00 GMT | 17:00 CET
Thursday, Nov 19 – 08:00 CET | 12:30 IST | 15:00 SGT | 16:00 JST

Attendees will get a critical look at the vaccine industry today, its globalization and how the cost of a vaccine is assessed. Different types of vaccine production processes, equipment, and activities will be reviewed with examples from influenza and inactivated polio vaccine manufacturing. Upstream cell expansion and antigen production, and downstream chromatography, inactivation, and formulation and filling will be explored. Strategies and philosophies for process optimization, safety, and quality—including the importance of QbD and final product sterility assurance and delivery—will also be studied.

To attend any of the webinars above, please visit Vaccine Production: Securing Process Quality with Flexible Manufacturing Solutions

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

Cool Tool – Xcellerex Automated Perfusion System provides a single-use, automated solution to simplify perfusion production

Perfusion culture is used to intensify bioprocess operations and provide improvement in efficiency and productivity for several different applications. Perfusion culture results in increased product output by continuously culturing and harvesting product over longer periods of time compared to traditional or fed batch methods. While extremely productive, perfusion often requires complex and labor-intensive set up and manual operation. It can also be limited in its single-use options, process integration and automation…

Cool Tool – Online Platform Makes Customizing Cell Therapy Media Effortless with 400 Publicly Available Formulas and Real Time Pricing Information

Media development for cell therapies can be a time consuming and costly effort, often involving testing of multiple formulas prior to selection. Some opt to select an off-the-shelf media option to save time and streamline development. However, additional customization to these formulations is often difficult because they involve proprietary formulations. In addition, cell therapy companies frequently include media composition as part of their intellectual property portfolio, which isn’t possible with an off-the-shelf formulation…

Successful Exosome production using Stem Cell Culture in Stirred Tank Bioreactors

Exosomes have been increasing in popularity as a possible therapeutic. They are being explored as an alternative to stem cell therapy for tissue and organ restoration. Exosomes are naturally occurring, mobile, membrane-limited, 30 – 100 nm in diameter, extracellular vesicles containing a large number of proteins, lipids, messenger, and micro-RNAs. They have been shown to play a role in the mediation of intercellular communication, the modulation of immune-regulatory processes, tumor metabolism, and regenerative as well as degenerative processes…

Erbi Biosystems introduces intensified and perfusion microfluidic bioreactor with stirred tank performance in just 2 mL working volume

Scaled down models are becoming increasingly important to cell line and media development, as well as overall process optimization. These models provide the opportunity to run multiple experiments in parallel at a fraction of the time and cost it would take to run larger scale experiments. In many cases, without scale down models, incredibly informative multi-factorial experiments would not be feasible…

Take Control of Your Titer Measurement with the Tridex™ Protein Analyzer

In this mini-webinar and accompanying article, Craig Love, Senior Applications Scientist for Bioprocess Analytics, IDEX Health and Science shares his experience on how to gain process insights and disrupt process bottlenecks by enabling titer measurement on demand with the Tridex Protein Analyzer….

Combining Ion Exchange and Reverse Phase Chromatography for Highly Efficient and Cost Effective Peptide Purification

Therapeutic peptide purification can be very challenging because of the similarities between peptides and their impurities. There is not a significant difference in retention for the target peptide and a peptide contaminant that has one amino acid that is different. Thus, separation of peptides from by-products requires long retention times that are inefficient. In addition, even small changes in the mobile phase composition can cause significant effects. One way to increase the separating power of RP-HPLC is to make use of an ion-pairing agent, which couples with basic amino acids, resulting in a net zero charge. Generating a net zero charge status enables separation using a reverse phase process. However, the duel reverse phase process can be cost prohibitive for peptides that require a high level of purity…

Strategies for Increasing Productivity and Reducing Cost of Chromatography in mAb Biomanufacturing

Increasing upstream titers, the need to increase throughput of existing facilities and the desire to reduce costs are just a few of the drivers forcing paradigm shifts in monoclonal antibody (mAb) downstream processes. These drivers are acutely felt in the selection of chromatography resins, as the purification step is often the source of bottlenecks and is costly…

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…

Headlines:

“Biogen Alzheimer’s drug closer to approval with U.S. FDA staff backing, shares jump 40%,” Reuters

Biogen Inc has shown “exceptionally persuasive” evidence that its experimental Alzheimer’s disease drug is effective, U.S. Food and Drug Administration staff said on Wednesday, elevating its chances of a swift approval and sending company shares soaring. An FDA approval could come by March, which would make the drug, aducanumab, the first new treatment for the disease in decades and the first that appears to be able to slow progression of the fatal, mind-wasting condition that affects millions of people…

“FDA publishes list of essential medicines, devices,” Regulatory Focus

To comply with a recent executive order, the US Food and Drug Administration (FDA) on Friday released a list of more than 300 essential drugs and medical devices that will serve as a basis for prioritized federal procurement of those products from domestic sources…

“Britain prepares for COVID-19 vaccine as Oxford forecasts result this year,” Reuters

Late-stage trial results of a potential COVID-19 vaccine being developed by the University of Oxford and AstraZeneca could be presented this year as the British government prepares for a possible vaccination rollout in late December or early 2021. A vaccine is seen as a game-changer in the battle against the coronavirus, which has killed more than 1.2 million people worldwide, shuttered swathes of the global economy and turned normal life upside down for billions of people…

“Erbi Biosystems raises $3.8M to expand their platform of microfluidic bioprocess and bioreactor equipment, which enables ultra-high cell density and continuous processing,” PR Newswire

Erbi Biosystems, a transformative microfluidic bioprocess instrumentation company based on technology developed at MIT, announced today the closing of a finance round which brings the total investment received to nearly $4M.  The round was led by Jaguar Biotech. “This new funding allows us to expand manufacturing, sales and support of our existing 2mL, TruePerfusion™ Breez™ bioreactor, while also funding further development of our technology platform and product pipeline,” said Michael Chiu, PhD, CEO of Erbi Biosystems.   “We recently shipped three complete systems to a global biopharma who will use it to improve their media development capabilities, based on our ability to provide discreet system control in a very small footprint,” said Kathie Schneider, Director of Product Management at Erbi Biosystems…

“J&J plans to test its COVID-19 vaccine in ages 12-18 soon,” Reuters

Johnson & Johnson plans to start testing its experimental COVID-19 vaccine in youths aged 12 to 18 as soon as possible, and the company’s previous experience with the same technology in a vaccine successfully used in children could give it a leg up with regulators. “We plan to go into children as soon as we possibly can, but very carefully in terms of safety,” J&J’s Dr. Jerry Sadoff told a virtual meeting of the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices on Friday…