This week’s headlines include: New Pfizer Results: Coronavirus Vaccine Is Safe and 95% Effective, FDA to make emergency use authorization data public for COVID-19 vaccines, NHS launches 40 ‘long COVID’ clinics, Senate panel recommends $96 billion for health department, New Type of Test May Better Discern Immunity to the Coronavirus, Adagio, ‘firing on all cylinders,’ grabs $80M for COVID-19 antibody, and Prepandemic coronavirus antibodies may react to COVID-19.

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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:

New Lab Set Up – Best Practices for a Successful Start

In this podcast, we spoke with Dr. Ann Rossi Bilodeau, Senior Bioprocess Applications Scientist and Dr. Catherine Siler, Field Applications Scientist both with Corning Life Sciences, who shared insightful tips for setting up a new lab. We discussed how to create a lab plan, maximize lab space, stay within budget and timelines. They also shared their experience in implementing lab safety and training as part of the new lab launch…

Ask the Expert – Viral Vector Manufacturing

Viral vector manufacturing is a critical part of most gene therapy and gene-modified cell therapy production processes. The Lentiviral vector is a commonly used vector for CAR T gene-modified cell therapies and has been key in the advancement of these therapies. In addition, Lentiviral vectors are also used in gene therapies to treat several genetic diseases. With the importance of these vectors to production, there has been a need to improve manufacturing processes. Areas for improvement include stable cell line development, scalability, upstream and downstream process optimization, and ensuring that a production process is ready for gene therapy commercialization. It is great to have expert help to navigate these opportunities for process improvement. For this Ask the Expert Session, we assembled a team of experts to answer questions on viral vector manufacturing and process improvement…

Intellifuge – A Next Generation Rotor Calculator Provides Users with a Whole New Level of Functionality

Scientists often use rotor calculators when configuring centrifugation workflows to optimize their processes, develop protocols or to convert existing protocols to fit with their workflow. Beckman Coulter Life Sciences has offered a popular online rotor calculator for years to help scientists with these tasks. Now Beckman Coulter has launched a free, next generation rotor calculator tool, Intellifuge, which expands the functionality of traditional rotor calculators. Improving on their original calculator, Intellifuge was designed to help scientists calculate, convert and configure products with ease. It contains new tools for adapting published protocols, optimizing existing protocols or converting from one protocol to another…

Cool Tool – Xcellerex Automated Perfusion System provides a single-use, automated solution to simplify perfusion production

Perfusion culture is used to intensify bioprocess operations and provide improvement in efficiency and productivity for several different applications. Perfusion culture results in increased product output by continuously culturing and harvesting product over longer periods of time compared to traditional or fed batch methods. While extremely productive, perfusion often requires complex and labor-intensive set up and manual operation. It can also be limited in its single-use options, process integration and automation…

Cool Tool – Online Platform Makes Customizing Cell Therapy Media Effortless with 400 Publicly Available Formulas and Real Time Pricing Information

Media development for cell therapies can be a time consuming and costly effort, often involving testing of multiple formulas prior to selection. Some opt to select an off-the-shelf media option to save time and streamline development. However, additional customization to these formulations is often difficult because they involve proprietary formulations. In addition, cell therapy companies frequently include media composition as part of their intellectual property portfolio, which isn’t possible with an off-the-shelf formulation…

Single-Use Tangential Flow Filtration (TFF) Offers Advantages for Viral Vectors and Vaccines

The advantages of single-use systems have been well documented in biomanufacturing for over a decade and are frequently used in the manufacture of monoclonal antibodies. Key areas where single-use systems provide real benefit over stainless steel counterparts is in reducing production change-over time and decreasing the cleaning and validation that requires significant time, labor, water and utility costs. Single-use systems also enable flexible facilities, require less capital investment and are quicker and easier to initiate than stainless steel facilities. These technologies are also often compatible with process automation…

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…

Headlines:

“New Pfizer Results: Coronavirus Vaccine Is Safe and 95% Effective,” The New York Times

The drug maker Pfizer said on Wednesday that its coronavirus vaccine was 95 percent effective and had no serious side effects — the first set of complete results from a late-stage vaccine trial as Covid-19 cases skyrocket around the globe. The data showed that the vaccine prevented mild and severe forms of Covid-19, the company said. And it was 94 percent effective in older adults, who are more vulnerable to developing severe Covid-19 and who do not respond strongly to some types of vaccines…

“FDA to make emergency use authorization data public for COVID-19 vaccines,” Reuters

The U.S. Food and Drug Administration said on Tuesday it would make public reviews of all data and information regarding the emergency use authorization (EUA) granted to COVID-19 drugs and vaccines. “Today’s transparency action is just one of a number of steps we are taking to ensure public confidence in our EUA review process for drugs and biological products, especially any potential COVID-19 vaccines,” FDA Commissioner Stephen Hahn said in a statement…

“NHS launches 40 ‘long COVID’ clinics,” PharmaTimes Online

The NHS is rolling out a network of more than 40 long COVID specialist clinics in the next few weeks to help thousands of patients who are suffering debilitating effects of coronavirus months after infection. The clinics will house doctors, nurses, therapist and other NHS staff under one roof offering physical and psychological assessments of those experiencing enduring symptoms…

“Senate panel recommends $96 billion for health department,” The Hill

The Department of Health and Human Services (HHS) would get $96 billion under a draft funding bill released Tuesday by the Senate Appropriations Committee, an increase of $2 billion from last year. The fiscal 2021 draft spending bill funds several programs intended to prepare the country for public health threats and emergencies like COVID-19. Public health experts argue Congress has underfunded their efforts for decades…

“New Type of Test May Better Discern Immunity to the Coronavirus,” The New York Times

A new type of test can detect a person’s immune response to the coronavirus better than a widely used antibody test, according to research released on Tuesday. The test, if authorized by the Food and Drug Administration, would be the first commercial product to detect the response of a T cell — a type of immune cell — to the virus. Antibodies have dominated the conversation on immunity since the start of the pandemic, but scientists believe that T cells may be just as important in preventing reinfection…

“Adagio, ‘firing on all cylinders,’ grabs $80M for COVID-19 antibody,” FierceBiotech

In a time when speed is of the essence, Adagio Therapeutics is gathering steam. It picked up $80 million to propel its COVID-19 antibody into the clinic next year, just four months after launching with $50 million and a plan to go after multiple members of the coronavirus family. The company is developing its lead prospect, ADG20, for the prevention of COVID-19 infection, as well as for the treatment of patients who have fallen ill. It may be zeroing in on SARS-CoV-2—the virus that causes COVID-19—but ADG20 and Adagio’s other antibodies are designed to protect against other coronaviruses, too. They bind to a piece of the spike protein that is found on multiple viruses, including SARS-CoV-1 and some coronaviruses circulating in bats…

“Prepandemic coronavirus antibodies may react to COVID-19,” CIDRAP

Two preliminary retrospective studies in the United Kingdom, sub-Sahara Africa, and the United States suggest that some people who were never infected with the virus that causes COVID-19 have cross-reactive antibodies against it—perhaps from previous exposure to similar human coronaviruses…