This week’s headlines include: Biden announces plans to acquire 100M more Johnson & Johnson vaccine doses, FDA’s inspection backlog: GAO raises concerns as delays mount, High Purity New England & Univercells Technologies Unveil Bioprocessing Solutions, Coalition eyes 100-day target for new vaccines against disease epidemics, BioNTech Sees Potential to Supply 3 Billion Doses in 2022, Merck says study shows COVID-19 drug causes quick reduction in virus, and Moderna taps Baxter to support fill and finish of 60-90 million COVID-19 vaccine doses.
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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
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Access today’s novel science and technologies needed for accelerating the development and production of COVID-19 vaccines and therapeutics by attending the upcoming BioProcess International COVID-19 Therapeutic Development & Production event, delivered in a 100% virtual format on April 27-28, 2021. Readers of Cell Culture Dish can save an extra 10% when you register with VIP code P21BPIWVDISH online at https://informaconnect.com/
March 17th 2021 – 11:00 AM (EDT) / 4:00 PM (CET)
Glutamine is an essential amino acid for cell culture media, but it’s often provided in an unstable form in commercial cell culture media. Dipeptides of @Evonik Health Care provide a stable form of glutamine that can improve the performance of your cell culture media. Learn more about glutamine dipeptides in Evonik’s free webinar with its leading experts Christian Kessler and Melanie Schölzel. Discover more: cellculture.evonik.com/
Methods to enhance transient transfection of adherent cells have identified many different ligands that improve plasmid uptake into cells. Of these ligands, serum-derived transferrin is well-known to improve transfection efficiency of adherent cells. However, to date, a serum-free and blood-free transferrin has not been tested for improvements to transfection efficiency. We have thus created a protocol for the improvement of transfection efficiency and viral titer without the need for blood-derived transferrin. Excess transferrin does not negatively impact transfection, and the incorporation of a blood- and serum-free, recombinant human transferrin supports high transfection efficiency and viral titer in a chemically defined, blood-free medium…
The development and manufacture of mRNA lipid nanoparticle (LNP) vaccines in record time is a testament to the incredible potential of emerging therapeutics in medicine today. Not only is this technology delivering on the herculean task of subduing a raging pandemic, but it is also being explored in vaccines for other infectious diseases and as treatments for cancer, multiple sclerosis, cystic fibrosis and others. As we look toward scaling and streamlining the production of RNA-LNP vaccines, it is important to evaluate how to improve the overall process. RNA-LNP therapeutics are complex to develop and accurate analytics are a key part of development and final release. Two key analytical techniques with room for improvement are RNA concentration and size distribution of lipid nanoparticles (LNP), which are the quality and efficacy of RNA-LNP vaccines…
In this podcast, we talked with Alan Dickson, Ph.D., Professor of Biology at the Manchester Institute of Biotechnology, University of Manchester about the evolution of the CHO Cell line from isolation to workhorse of the biomanufacturing industry, to gene edited knockout variants. It is an interesting look at why CHO cells have been so successful and how this success continues to be improved upon for manufacture of emerging therapeutics…
The insights into reimbursement of gene therapies presented in this article explore challenges and potential solutions based on the U.S. healthcare landscape. While not directly applicable to other nations, risks and solutions identified here may be a starting point for exploration of short and long-term sustainability discussions for other countries...
With over 350 cell and gene therapies in clinical trials in the US and more than 700 globally, the explosive growth in the field is only expected to increase in the years to come. This rapid progress from clinical development towards product licensure has resulted in a viral vector supply bottleneck. The challenge in viral vector-manufacturing capacity is estimated to be 1–2 orders of magnitude lower than what is needed to support current and future commercial supply requirements. Concomitantly, regulatory scrutiny and product characterization requirements are increasing, as more gene therapy products reach commercialization…
Buffer management is a significant logistical challenge in biomanufacturing and is the cause of many bottlenecks. While it is an essential function in downstream processing, it does not provide added value commensurate with the level of footprint, labor and equipment investment required…
Don’t miss our top articles on downstream processing for 2020! I have compiled a list of our most popular articles from 2020 in alphabetical order…
The downstream manufacturing process takes the output from upstream operations and transforms it through multiple steps into a viable drug product ready for administration to patients. The major challenge in downstream processing is to maximize yield while meeting both product and impurity specifications. Viral vectors destined for clinical use must comply with regulatory standards for product safety and potency and this means contaminants must be removed and impurities controlled…
Faster process times and increased flexibility in manufacturing continue to be key drivers in both upstream and downstream processing. New technologies are needed to address bottlenecks and to infuse more flexibility in process development and manufacturing. For downstream, chromatography purification can be a resource intensive step and a source of bottlenecks due to decreased throughput. While improvements in Protein A chromatography resins, such as high capacity resins, provide much better capacity, low flow rates are still a potential source of slow downs. One alternative solution for addressing areas where increased throughput and flexibility is required is the use of Fiber based chromatography…
President Joe Biden on Wednesday said his administration plans to order 100 million additional COVID-19 vaccine doses from Johnson & Johnson. Biden met with Johnson & Johnson CEO Alex Gorsky and Merck CEO Ken Frazier for a discussion at the White House on Wednesday afternoon, and he praised the two companies for coming together to produce vaccines and accelerate distribution…
For decades, the Government Accountability Office (GAO) has raised concerns about the US Food and Drug Administration’s (FDA) inspections program. Now, a year after the agency halted most of its foreign and domestic inspections due to the COVID-19 pandemic, GAO warns that the ensuing backlog could take years to clear. In a new report and testimony before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, GAO Health Care Director Mary Denigan-Macauley, PhD, said that the agency needs to come up with a plan to address the looming inspections backlog and tackle some of its longstanding issues…
High Purity New England (HPNE), a supplier of solutions for the biopharma industry, has officially introduced a new line of fixed-bed, single-use bioreactors from Univercells Technologies for the U.S. Market. This new highly scalable line of bioreactors is designed to ensure seamless scalability from early process development to commercial manufacturing. The scale-X fixed-bed bioreactor range and the NevoLine Upstream platform are available immediately in the U.S. market through High Purity New England…
An international coalition set up to prepare for future infectious disease threats set out what it called its “moonshot” plan on Wednesday to ensure new vaccines against emerging disease epidemics are developed within 100 days. Launching a $3.5 billion five-year strategy to tackle future pandemic risks, the Coalition for Epidemic Preparedness Innovations (CEPI) said more needs to be done urgently to mitigate the threat posed by new COVID-19 variants, and to prepare for new infectious diseases…
BioNTech SE could have capacity to make 3 billion doses of Covid-19 vaccine with U.S. partner Pfizer Inc. next year, the German company’s chief executive officer said, making their pioneering shot far more widely available around the world. “In principle, we could further increase manufacturing capacity,” Ugur Sahin said Tuesday in an interview with Bloomberg TV. “It depends on demand, it depends on factors such as if an additional boost to vaccinations is required.” Demand is growing around the world for Covid vaccines that countries desperately need to breathe back life into economies, return children to schools and get people back into offices and shops. Both the U.S. and Europe have sought to accelerate vaccine deliveries this year as new, more aggressive variants of the virus spread…
U.S. drugmaker Merck & Co Inc said on Saturday the experimental antiviral drug molnupiravir it is developing with Ridgeback Bio showed a quicker reduction in infectious virus in its phase 2a study among participants with early COVID-19. “The secondary objective findings in this study, of a quicker decrease in infectious virus among individuals with early COVID-19 treated with molnupiravir, are promising,” said William Fischer, Associate Professor of Medicine at the University of North Carolina School of Medicine, in a statement from the companies…