The Dish’s Weekly Biotechnology News Wrap Up – October 30, 2020
This week’s headlines include: UK starts real-time review of Moderna’s COVID-19 vaccine candidate, Medicare and Medicaid to cover early Covid vaccine, Regeneron says its COVID-19 antibody treatment cut medical visits in trial, This 12-year-old is happy to be testing a Covid-19 vaccine, FDA plans master protocols to monitor COVID vaccine safety, efficacy, and FDA advisory committee debates safety and efficacy standards for a coronavirus vaccine.
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
Upcoming Webinar:
Stem cell derived exosome production in stirred-tank bioreactors
Exosomes are a population of naturally occurring mobile, membrane-limited, 30 – 100 nm in diameter, extracellular vesicles containing a large number of proteins, lipids, messenger, and micro-RNAs. It was shown that they play a role in the mediation of intercellular communication, the modulation of immune-regulatory processes, tumor metabolism, and regenerative as well as degenerative processes. In recent years, there is increasing interest in the therapeutic potential of exosomes produced by Mesenchymal Stem Cells (MSCs).
Stirred-tank bioreactors offer the possibility to tightly control and monitor the production of exosomes, as well as the scalability, to produce increasing amounts. However, the cultivation of stem cells in stirred-tank bioreactors requires profound knowledge and precise control of the process.
In our talk, we will highlight the potential and benefits of stirred-tank bioreactors in the cultivation of stem cells for exosome production. We will share our knowledge on how we developed the process in our DASbox® Mini Parallel Bioreactor System and scaled-up the process to 1 L controlled by our newest parallel bioreactor control system, the SciVario® twin.
Webinar Series:
Vaccine Production: Securing Process Quality with Flexible Manufacturing Solutions
Downstream process development for vaccine manufacturing
Tuesday, Nov 03 – 08:00 PST | 11:00 EST | 16:00 GMT | 17:00 CET
Thursday, Nov 05 – 08:00 CET | 12:30 IST | 15:00 SGT | 16:00 JST
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:
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….
Successful Techniques for Progressing Biotherapeutic Candidates from Discovery to the Clinic
The reality is that many initially promising biotherapeutic candidates never make it to commercialization. It is estimated that only 1 in 1000 preclinical candidates reach the commercial market. Why does this happen? There are many that fail due to lack of efficacy or safety, but there are also candidates that fail due to stability, aggregation, and other issues related to cell line or process issues. While some issues may never be satisfactorily resolved to the point where commercialization is possible, others can be saved with early identification, engineering and process development approaches. Even for candidates that can’t be rescued, it is critical to know this early, so that time and resources aren’t wasted on a product that ultimately has no path forward. Therefore, it is imperative that strategies and technologies are available to evaluate and identify issues early in the development phase and address challenges where possible…
Viral Vector Process Intensification: Stepwise Model for Efficient Scale-up
The unprecedented clinical success of novel cell and gene therapies (CGT), such as CAR-T cell therapy, has led researchers to shift from treating more rare conditions present in smaller populations to those more prevalent in the general population. This has, in turn, resulted in a growing market demand for the viral vectors used in these therapies. It has highlighted the need to increase manufacturing capacity to meet market demands by developing scalable and cost-effective viral vector manufacturing processes and improving methods for purification and analysis to ensure product purity, efficacy, and safety. Research and Markets recently reported the global viral vector manufacturing market was valued at US$459.4 million in 2019 and – expected to reach US$2.2 billion by 2027…
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:
“UK starts real-time review of Moderna’s COVID-19 vaccine candidate,” Reuters
Moderna Inc said on Tuesday United Kingdom’s health regulator has started a real-time review of its experimental COVID-19 vaccine. The company has begun a rolling data submission from its vaccine candidate to UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for it to start its independent assessment of evidence as and when it becomes available…
“Medicare and Medicaid to cover early Covid vaccine,” Politico
The Trump administration this week will announce a plan to cover the out-of-pocket costs of Covid-19 vaccines for millions of Americans who receive Medicare or Medicaid, said four people with knowledge of the pending announcement…
“Regeneron says its COVID-19 antibody treatment cut medical visits in trial,” Reuters
Regeneron Pharmaceuticals Inc said on Wednesday its coronavirus antibody cocktail – the experimental treatment that U.S. President Donald Trump received – significantly reduced medical visits in a trial of nearly 800 patients with mild-to-moderate COVID-19…
“This 12-year-old is happy to be testing a Covid-19 vaccine,” CNN Health
The youngest volunteers so far to get experimental coronavirus vaccines have been given their first doses and are now being watched carefully to see if they are experiencing any unusual side effects. A team at Cincinnati Children’s Hospital vaccinated 100 children as young as 12 last week, said Dr. Robert Frenck, who is leading the trial for Pfizer’s Covid-19 vaccine at the hospital. “Now we are pausing to watch for reactions to the vaccine. We right now are in a planned pause to make sure that everything is as safe as it can be,” Frenck told CNN…
“FDA plans master protocols to monitor COVID vaccine safety, efficacy,” Regulatory Focus
After a vaccine against COVID-19 is authorized or approved, how will its safety and efficacy be assessed? In addition to ongoing postmarket surveillance requirements, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) will strive for near real-time safety and efficacy surveillance of COVID-19 vaccines. FDA is currently developing master protocols to guide its safety and effectiveness oversight, said an FDA official during the FDA’s first COVID-19 vaccine-focused advisory committee hearing. “We’ll be posting the protocols for public comment,” said Stephen Anderson, PhD, director of the Office of Biostatistics and Epidemiology at FDA’s Center for Biologics Evaluation and Research (CBER)…
“FDA advisory committee debates safety and efficacy standards for a coronavirus vaccine,” The Washington Post
Vaccine experts on Thursday rigorously debated the Food and Drug Administration’s planned standards for clearing a coronavirus vaccine quickly for broad use, discussing what level of evidence would be sufficient to establish safety and effectiveness. The FDA advisory committee, in an all-day virtual meeting, did not consider any specific vaccine. The session served in large part as a venue for the agency to try to reassure the public that any vaccine will be held to a high standard, not the relatively low bar used this year for emergency use authorization for treatments. The FDA said that though it probably will grant emergency use authorizations — which can be handed out faster than full approvals — for the early vaccines, it will use robust criteria similar to those applied in regular approvals…