This week’s headlines include: CBER lays out scaled-down guidance agenda for 2021, AstraZeneca, Oxford expect ‘next generation’ COVID-19 vaccine to tackle variants by autumn – executive, Bristol Myers Gains Covid Antibody in Deal With Rockefeller, Dangerous new coronavirus strains may incubate in COVID-19’s sickest, Vertex Moves Full Steam Ahead on Type 1 Diabetes Drug Trial With FDA’s OK, Mammoth Biosciences teams with Agilent to deliver CRISPR-based coronavirus tests, and Federal agencies will study Covid vaccine effectiveness on ‘mutant’ strains, Fauci says.

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

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

3D cell culture bioreactor system for growing and maintaining spheroids and organoids with the structure and function of in vivo cells

In this podcast, we spoke with Prof. Stephen Fey, Chief Research Officer and Co-founder, CelVivo about the importance of 3D culture and the challenges associated with growing and maintaining culture in 3D.  We also discussed using a 3D culture bioreactor system, which employs clinostat technology to culture spheroids and organoids in a way that maintains the structure and function of in vivo cells…

Top Cell Culture Dish Podcasts for 2020

Don’t miss our top Podcasts of 2020! I have compiled a list of our most popular 15 Podcasts for 2020 in alphabetical order…

Bio-Techne’s GMP ProDots Proteins™: Closing the Loop in Cell Therapy Manufacturing

As cell therapy manufacturing continues to grow, patient safety is at the core of developing robust and efficient manufacturing processes. The ability to close the manufacturing process mitigates the risk to the final therapeutic and ensures an efficient, de-risked, cost effective process. To close the gap on the addition of critical cytokines into the process, Bio-Techne has developed GMP ProDots™ Proteins, lyophilized spheres of protein inside single-use sterile, weldable bags that can be directly integrated into closed process systems…

CelVivo’s ClinoStar can grow organoids or spheroids that mimic the function, structure, and architecture of in vivo cells

It has been demonstrated over the past several decades that three-dimensional (3D) cell culture provides a superior system for mimicking the in vivo environment. Historically, flat, two-dimensional (2D) monolayer cells were the only practical option available, however, they are seriously limited in their ability to recapitulate normal tissue responses because they lack tissue-specific cytoarchitecture, in vivo mechanical and biochemical cues, and cell-to-cell interactions…

mRNA Vaccine Production and Facility Design

Over the past year we’ve witnessed an explosion of activity in both vaccine research and manufacturing due to SARS-CoV-2. We’ve also seen an increased appreciation of what had been some rather obscure, though highly significant, technologies. These include vaccine types and sub-types, ranging from exosome encapsulated AAV vectored vaccines in a prime-boost system, to the lipid nanoparticle delivered mRNA of a viral antigen. While traditional platforms remain in use, innovative delivery systems now include entirely synthetic antigenic structures, sub-viral particles, and chimeric bacterial ghosts. Antigen production platforms employ such diverse approaches as animal tissues, cell-free expression, whole plants, cell culture and direct chemical synthesis…

The BioContinuum™ Buffer Delivery Platform Provides Solutions to Costly Buffer Management Pain Points

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…

Top Downstream Process Articles of 2020

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…

Downstream Manufacturing of Gene Therapy Vectors

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…

Addressing Downstream Throughput Bottlenecks with Rapid Cycling Protein A Based Fiber Chromatography

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…

Headlines:

“CBER lays out scaled-down guidance agenda for 2021,” Regulatory Focus

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has released its list of draft and final guidances it plans to issue in 2021. The list contains just 14 guidances, half of which will be draft documents, down from 31 guidances in 2020 and 20 guidances in 2019. Of those 14 guidances, only a few are new additions to the list, with the remainder being carried over from the previous year…

“AstraZeneca, Oxford expect ‘next generation’ COVID-19 vaccine to tackle variants by autumn – executive,” Reuters

AstraZeneca and Oxford University aim to produce the next generation of COVID-19 vaccines that will protect against variants as soon as the autumn, a senior executive at the British drugmaker said on Wednesday. Asked when AstraZeneca could produce a next generation vaccine to tackle new variants, AstraZeneca research chief Mene Pangalos said “as rapidly as possible”…

“Bristol Myers Gains Covid Antibody in Deal With Rockefeller,” Bloomberg

Bristol Myers Squibb Co. has clinched a deal with The Rockefeller University for the rights to a Covid-19 therapy that combines two antibodies, the drugmaker said Wednesday. Rockefeller began human trials of the experimental treatment in mid-January. The agreement, for an undisclosed sum, grants Bristol Myers an exclusive license to develop, manufacture and commercialize the therapy globally. Rockefeller is entitled to royalty payments on potential future sales…

“Dangerous new coronavirus strains may incubate in COVID-19’s sickest,” The Los Angeles Times

Among the 100 million people around the world who have battled coronavirus infections, scientists are turning to the case of a 45-year-old COVID-19 patient in Boston to understand how the virus is able to outwit humans. During his 154-day illness — one of the longest on record — the patient’s body became a crucible of riotous viral mutation. He offered the world one of the first sightings of a key mutation in the virus’ spike protein that set off alarm bells when it was later found in strains in the United Kingdom, South Africa and Brazil…

“Vertex Moves Full Steam Ahead on Type 1 Diabetes Drug Trial With FDA’s OK,” Biospace

The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes (T1D). The therapy, now dubbed VX-880, is described by the company as being “an investigational allogeneic human stem cell-derived islet cell therapy” which holds the potential to restore the body’s ability to normalize glycemic levels via restoration of pancreatic islet cell function…

“Mammoth Biosciences teams with Agilent to deliver CRISPR-based coronavirus tests,” FierceBiotech

CRISPR-wielder Mammoth Biosciences will team up with Agilent Technologies to help launch its upcoming COVID-19 diagnostic test, designed to handle more than 4,000 samples per day. Applying the gene editing technology allows the system to operate much faster than standard PCR-based molecular lab tests, according to Mammoth. The company’s CRISPR-based DETECTR assay uses Cas12 enzymes to identify and tag the coronavirus’s specific genomic sequences and provides a visual result that can be read by a machine…

“Federal agencies will study Covid vaccine effectiveness on ‘mutant’ strains, Fauci says,” CNBC

Top U.S. health agencies will collaborate to study how effective Covid-19 vaccines are against mutated strains of the virus that have been discovered in various parts of the world, White House health advisor Dr. Anthony Fauci said Wednesday. The Centers for Disease Control and Prevention is working to ramp up the country’s capacity to conduct genomic sequencing and monitor for mutations of the virus, CDC Director Dr. Rochelle Walensky said Wednesday at a White House Covid-19 briefing. Fauci added that the National Institutes of Health will work with the CDC to study the vaccines’ effectiveness against new variants…