This week’s headlines include: Trump’s ‘Operation Warp Speed’ Aims to Rush Coronavirus Vaccine, WHO launches ambitious global project to develop Covid-19 medical products, US Preps For ‘COVID-19 Mass Vaccination’ With $110 Million Spent On Needles And Syringes, FDA tightens oversight of antibody tests for COVID-19, Pfizer Begins Human Trials of Possible Coronavirus Vaccine, US government will decide where remdesivir goes amid coronavirus pandemic, drugmaker says, Pfizer aims for 10-20 million doses of coronavirus vaccine by end-2020, and Clinical Trials Of Mesoblast’s Stem Cell Treatment For COVID-19 Set To Begin Soon.
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:
May 18-19, 2020 – Minneapolis, MN
The course is offered for both in class attendance and over the web for those who cannot attend in person.
The course is designed for a wide range of participants. The preservation of cells has applications in the fields of recombinant cell biotechnology, cell banking, cell therapy, regenerative medicine, and cell-based assays, for example. Previous attendees have ranged from manufacturing engineers, laboratory managers, technicians, nurses, and scientists, and several companies have used the course as standard training for their employees. The course material is designed for those who have little experience with preservation, as well as those proficient in preservation who is interested in improving their practices.
- Fundamentals of cryopreservation including mechanism of damage and strategies to prevent damaging cells during freezing, storage and warming,
- Step-by-step protocol development including methods by which to construct a new preservation protocol and debugging an old protocol that is no longer working well,
- Equipment, reagents and supplies used in preservation,
- The challenges in implementing preservation in a clinical/GMP environment,
- Fundamentals of quality control (QC) and quality assurance (QA) as well as application of the program to preservation,
- Design and operation of a storage facility for cryopreserved cells,
- Regulatory issues associated with preservation of a therapeutic product,
- Emerging technology and approaches for the preservation of cells.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Bioprocess intensification is a term that we hear often, but it is difficult to define or rather there are often several definitions depending on the perspective of the author. That said, it is generally considered a toolbox of strategies to improve the biomanufacturing process and make it more efficient. What is meant by “efficient” is a metric that has to be defined by the group working to intensify the process. It could be increasing productivity, lowering manufacturing costs, better utilization of facility space, reducing timelines, improving product quality or all of the above and more…
Spent media analysis is a critical part of biotherapeutic process development. The ability to analyze how cell culture components are consumed provides data that speaks to the health and productivity of the culture itself. The data generated allows multiple groups within process development to work together to ensure the best overall process; this includes cell line development, media formulation, process optimization, and purification…
Mesenchymal Stromal Cell Culture – Challenges and solutions for isolation, expansion and maintenance
In this podcast and accompanying article, we talked with Dr. Jennifer Chain, Scientific Director of Research and Development, Oklahoma Blood Institute about isolation of mesenchymal stromal cells from cadaveric bone marrow and the differences between live and cadaveric donors. We also discussed the expansion and maintenance of mesenchymal stromal cells in culture including media design and selection…
Cell Line Development – A look at the evolution, new advances and future developments of this critical process step
In this written interview, Dr Ian Taylor, Chief Business Officer, Solentim, discusses the evolution of cell line development, new advances in technologies and workflows, and future advances. Our discussion includes improved imaging techniques, manual limiting dilution versus single cell seeding, and achieving clonal outgrowth…
Cool Tool – Real-Time Protein Titer Measurement Provides Fast, Simple Solution for Process Development and Production
Protein titer data is a critical during process development and manufacturing of protein-based biopharmaceuticals. Speed and accuracy of this data is key in instituting a process analytical technology (PAT) approach, as this allows for monitoring critical process parameters (CPP) and informs real-time decision making. In addition, this type of data when collected during process development enables optimization of cell culture conditions, protein yield, bioreactor run length and harvest time. Collecting this data during a bioreactor run is ideal, but can be time consuming and resource intensive with traditional tools…
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…
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…
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…
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…
“The Trump administration is organizing a Manhattan Project-style effort to drastically cut the time needed to develop a coronavirus vaccine, with a goal of making enough doses for most Americans by year’s end. Called “Operation Warp Speed,” the program will pull together private pharmaceutical companies, government agencies and the military to try to cut the development time for a vaccine by as much as eight months, according to two people familiar with the matter…”
“Univercells Technologies, a global provider of next-gen bioprocess technologies, has been launched as a subsidiary of Univercells, under which it will focus on the commercialization of the product portfolio and explore new technology developments to expand its position in the cell and gene therapy market. According to Mathias Garny, General Manager of Univercells Technologies, “With the scale – X bioreactor portfolio and the NevoLine biomanufacturing platform, designed and commercially validated by Univercells, the company experiences a turning point. The commercialization of these cutting-edge technologies under a dedicated brand will boost the expansion of our market reach to support advances in cell and gene therapy manufacturing,”
“Led by the World Health Organization, a long list of countries, industry groups, and nongovernmental organizations committed to joining a project for developing and producing new drugs, vaccines, and tests for Covid-19 — and ensure worldwide access to the products. The orchestrated move, which is being called the Access to COVID-19 Tools Accelerator, comes as the pandemic has infected more than 2.7 million people and claimed approximately 191,000 lives, sparking urgent calls for global cooperation in devising a medical response…”
“The U.S. government is getting its vaccine supplies ready in anticipation of a working cure. Two separate orders signed off on May 1, 2020, total $100 million and specify needles and syringes “for a COVID-19 Mass Vaccination Campaign.” One $27.5 million order went to Colorado-based Marathon Medical, the other $83.7 million to Texan business Retractable Technologies. The orders were placed by the Health and Human Services (HHS) department’s Office of the Assistant Secretary for Preparedness and Response (ASPR)…”
“After initially allowing commercial manufacturers and laboratories to market self-validated antibody tests for coronavirus disease (COVID-19), the US Food and Drug Administration (FDA) says that commercial manufacturers must now submit an emergency use authorization (EUA) with validation data to continue marketing the tests…”
“Pfizer and the German pharmaceutical company BioNTech announced that their potential coronavirus vaccine began human trials in the United States on Monday. If the tests are successful, the vaccine could be ready for emergency use here as early as September. The two firms are jointly developing a vaccine candidate based on genetic material known as messenger RNA, which carries the instructions for cells to make proteins. By injecting a specially designed messenger RNA into the body, the vaccine could potentially tell cells how to make the spike protein of the coronavirus without actually making a person sick…”
“The federal government will begin shipping “tens of thousands” of courses of remdesivir early this week and will decide where the medicine goes, according to Daniel O’Day, chairman and CEO of Gilead Sciences, the maker of the investigational drug.
“The companies, whose project relies on messenger RNA technology never before used in an approved vaccine, have dosed the first humans in Germany and hope to begin a U.S. trial soon, pending regulators’ blessing. Pfizer, BioNtech and other companies are racing to develop a vaccine, since there are currently no approved treatments and only mixed results of medicines under study against the virus…”
“Melbourne-based biotech company Mesoblast announced earlier this week that it’s begun enrolling up to 300 patients for a randomized, controlled study of its stem cell therapy remestemcel-L in the treatment of COVID-19 patients experiencing acute respiratory distress syndrome. Over 20 hospitals will participate in the study, which is anticipated to last 3-4 months…”