The Dish’s Weekly Biotechnology News Wrap Up – March 26, 2021

March 26, 2021 Written by Brandy Sargent

This week’s headlines include: Trial looking at mixing-and-matching different COVID vaccines could be game-changer, Antibody drug cuts COVID-19 death risk by 70 percent, Biocentriq Partners with MIT Spinout Kytopen, U.S. FDA approves J&J’s multiple sclerosis treatment; launch in April, CBER sets strategic priorities through 2025, U.S. production of COVID-19 vaccine dramatically speeds up, and SARS-CoV-2 D614G Mutation Stabilizes Spike Protein, May Explain Faster Spread.

Podcasts:

Check out our podcast channel. We have over 50 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:

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

Conferences:

BioProcess International US West Conference & Exhibition

Cell Culture Dish Readers can get a Free Virtual Exhibition Visitor Pass to BPI West 2021 | March 29-31, 2021

Learn about today’s novel bioprocessing technologies designed to accelerate speed to market for your biologics by attending the upcoming BioProcess International US West Conference & Exhibition, delivered in a 100% virtual format on March 29-31, 2021. Register for your free virtual exhibition visitor pass to access 30+ virtual exhibits, 50+ on-demand technology workshop presentations and live networking sessions with solution providers working across the entire spectrum of biopharmaceutical development and production.

Book your free virtual exhibition visitor pass. – https://informaconnect.com/bpi-west/?utm_source=cell-culture-dish&utm_medium=web-banner

BioProcess International COVID-19 Therapeutic Development & Production

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/bioprocess-international-covid-19/?utm_source=cell-culture-dish&utm_medium=web-banner

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

Cell Therapies Require Well-defined, Optimized Media to Enable Efficient Transition Between Research, Clinical and Manufacturing Scale Culture

The ongoing success of cell therapies in the clinical setting has put an increased focus on optimizing the manufacturing process for these therapies. In particular, cell expansion for clinical use is critical and requires a highly optimized media appropriate for clinical and commercial manufacturing. Increasingly the industry is moving towards using well-defined media without the addition of serum. In addition, clinical and ultimately commercial manufacturing requires a scalable process. This includes a medium that enables large-scale manufacturing systems, such as microcarrier-based suspension culture platforms…

Cell Culture Dish – Top 25 Articles of 2020

Don’t miss our top articles of 2020! I have compiled a list of our 25 most popular articles for 2020 in alphabetical order…

Understanding Cell Culture Media

Cell culture media greatly impacts biomanufacturing in both positive and negative ways. Variability in cell culture media and associated raw materials can create variation in the upstream manufacturing process, as well as impacting final product quality. New analytical technologies have made it possible to have a better understanding of what contributes to cell culture media variability and as a result it is incumbent on cell culture media suppliers to implement control processes and a robust quality assurance program…

The Art and Science of Cell Food: How smart media formulations drive performance

The old adage ‘you are what you eat’ could equally be said for cell culture, because the quality of what you put into your bioreactor dictates the quality of what comes out. Several major challenges with cell culture media and processes must be overcome to unlock the full potential for successful discovery and efficient production of biopharmaceuticals. Many of these challenges are now being addressed through a unique and innovative portfolio of dipeptides that boost performance...

Sterile Connections – A Critical Part of Fluid Transfer in Viral Vaccine Production

Being able to move fluid aseptically using sterile connections is a critical part of the viral vaccine production process. Sterile connections are responsible for how fluid is transferred from one technology to another unit operation. From upstream to downstream and into final formulation and fill, there are multiple points of fluid transfer in vaccine production. The points of transfer must be sterile and failsafe to avoid lost batches due to contamination and ultimately to ensure patient safety. Too often, creating these sterile connections and processes can take considerable time and resources. One challenge is that many available connectors are difficult to use and thus there is an increased risk of failure…

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…

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:

“Trial looking at mixing-and-matching different COVID vaccines could be game-changer,” CBS News

While most COVID-19 vaccine trial volunteers have no idea whether they’re getting the real vaccine or a placebo, for the volunteers participating in a potentially paradigm-shifting new study in the U.K., there is no placebo. It’s not a question of whether they’ve had a shot, but which one — or rather, which two…

“Antibody drug cuts COVID-19 death risk by 70 percent,” The Hill

Regeneron Pharmaceuticals announced Tuesday that its COVID-19 antibody treatment has proven in a clinical study to sharply reduce the risk of hospitalization or death among patients who test positive for the virus. The company announced on its website that a trial involving more than 4,500 patients indicated that Regeneron’s treatment reduced both risks by 70 percent…

“Biocentriq Partners with MIT Spinout Kytopen,” Genetic Engineering News

BioCentriq™, the NJ Innovation Institute’s cell and gene therapy development and manufacturing center and a CDMO, has partnered with Kytopen, a Cambridge-based startup spun out of MIT. The respective teams initially will focus on demonstrating the impact to both autologous and allogeneic cell therapies by integrating Kytopen’s Flowfect^® transfection technology with other steps in the manufacturing process…

“U.S. FDA approves J&J’s multiple sclerosis treatment; launch in April,” Reuters

Johnson & Johnson will launch its newly approved drug for adults with relapsing multiple sclerosis (MS) in the United States in early April 2021 at a similar price point to rival treatments, the company’s unit said on Friday. With the approval, the drugmaker enters a market currently dominated by big names like Roche’s Ocrevus, Novartis’ Kesimpta and Gilenya, and Biogen’s top-selling drug Tecfidera…

“CBER sets strategic priorities through 2025,” Regulatory Focus

Facilitating product development, conducting research, boosting preparedness against health threats and organizational excellence top the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) strategic goals for the next five years. Those goals are detailed in CBER’s 42-page strategic plan, released Wednesday, and account for new legislation and scientific advances since the center’s previous interim plan for FY2017-2019. That legislation includes the 21^st Century Cures Act, the FDA Reauthorization Act of 2017 and the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. (RELATED: CBER strategic plan 2017-2019: Increase threat preparedness, improve international collaborations, Regulatory Focus 17 October 2016)…

“U.S. production of COVID-19 vaccine dramatically speeds up,” The Wall Street Journal

COVID-19 vaccine manufacturers are ramping up production, churning out far more doses a week than earlier in the year, progress that is accelerating mass vaccination campaigns in the U.S. After a slow start, Pfizer Inc. PFE, +0.17%, its partner BioNTech SE BNTX, +1.15%, and Moderna Inc. MRNA, +1.31% have raised output by gaining experience, scaling up production lines and taking other steps like making certain raw materials on their own. Pfizer figured out how to stretch scarce supplies of special filters needed for the vaccine production process by recycling them. Moderna shortened the time it needed to inspect and package newly manufactured vials of its vaccine…

“SARS-CoV-2 D614G Mutation Stabilizes Spike Protein, May Explain Faster Spread,” Genetic Engineering News

The SARS-CoV-2 variants that have emerged in the past few months have attracted an immense amount of speculation. Specifically, whether the mutations may confer an advantage to the virus, render our antibodies ineffective, and lead to vaccine escape. New research has uncovered why the G614 strain (with a substitution for aspartic acid by glycine at position 614 in the spike protein) and its recent variants—which are now the dominant circulating forms of the virus—facilitate rapid viral spread…