This week’s headlines include: J&J COVID-19 shot gets better boost from Moderna or Pfizer in NIH study, Merck seeks first U.S. authorization for COVID-19 pill, FDA drafts safety reporting guidance for drug and device investigators, A ‘Historic Event’: First Malaria Vaccine Approved by W.H.O., In a first, COVAX to send COVID shots only to least covered nations, and How exploiting a protective gene mutation might shield the brain from Alzheimer’s disease.

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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:

Media Optimization for Cell Therapy Production

In cell-based therapies, the cultured cells are the therapeutic product, which necessitates different manufacturing processes as compared with other biologics productions. As a cell therapy developer, the big considerations in the scale-up process include the input cells, culture vessels, and culture media. Inadequate consideration and planning can not only impact the efficacy of the cell therapy, but also present costly regulatory roadblocks that can delay progress through the product pipeline. Since the culture media is linked to the growth and productivity of the cells, it is one of the most critical aspects of process development during scale-up…

Utilizing Optimized Protein Expression Systems to Advance Development of Therapeutics Against Infectious Diseases

The rapid emergence and spread of novel infectious diseases such as COVID-19 caused by the SARS-CoV-2 virus has highlighted the need for innovative protein expression solutions to support rapid and comprehensive virus characterization, serological testing, therapeutic antibody and vaccine development to mitigate these threats to global health. A recent white paper published by Thermo Fisher Scientific entitled Advancing the development of therapeutics against infectious diseases with optimized protein expression systems highlights how their comprehensive portfolio of mammalian and insect transient protein expression systems can accelerate and streamline infectious disease research and meet high-yield bioproduction requirements for the development of diagnostics and therapeutics that can mitigate virus spread…

3D Human Liver Spheroids: Moving Towards Meaningful In Vitro Assays

During the Society of Toxicology virtual meeting held between March 12–26, 2021, Corning® Development Associate Feng Li, Ph.D. gave an interesting presentation alongside Michael Johnson, Ph.D., CEO of Visikol, Inc., on the use and physiological relevance of 3D human liver spheroids to conduct in vitro hepatotoxicity assays and other applications. Corning offers a wide range of matrices and tissue-culture plates (i.e., Corning Elplasia® plates) as well as primary human hepatocytes to support small and large-scale production of liver spheroid cultures for drug toxicity screens…

Hassle-free nanoparticle characterization with Stunner

The use of nanoparticles in medicine offers exciting new possibilities to deliver RNA, DNA, and protein payloads with more diverse therapeutic applications than ever before. Notably, lipid nanoparticle carriers are integral to the success of the COVID-19 messenger RNA (mRNA) vaccine aimed at activating immune cells against the SARS-CoV-2 virus. The diversity of potential payloads and applications has led to the creation of many forms of organic nanoparticles and includes liposomes, lipid nanoparticles (LNP), solid lipid nanoparticles, nano-emulsions, polymeric lipid nanocarriers and other proprietary or specially formulated particles for targeted delivery…

The Evolution of Cell Therapy Manufacturing: Part II – A Promising Future

In Part I the rather wide spectrum of medical treatments referred to as Cell Therapy was introduced.  This diversity includes the proximate source of the cells, the cell type, any activation or engineering required, the mode of cell culture, and the therapeutic indication. Processes in the early days of adoptive transfer therapies, such as Rosenberg’s in-house produced TIL were described.  That outline presented current practices, general facility requirements, equipment currently employed, and examples of newly commercialized cell therapy (CT) equipment including those providing semi-automated and locally closed processing…

Mastering the Fundamentals of Oligo Development

With over 300 candidates in clinical trials, oligonucleotides are one of the most promising therapeutic modalities and for the foreseeable future – and solid phase synthesis remains the gold standard approach for manufacturing. Benefits include the relative ease of developing a synthesis route, the straightforward path to scale-up and improved in-process controls. For all the complexity that exists in oligonucleotide development – from end to end – a mastery of synthesis fundamentals can go a long way toward a successful run…

Future-proof Bioprocesses: Flexible Single-use Technology that Adapts to an Evolving Industry

The one constant in biopharmaceutical manufacturing is change. There is an ever-present need to adapt to new therapeutic modalities, more cost-effective approaches, higher product demands, and now a worldwide pandemic. Thus, the best way to ensure efficient biomanufacturing is to future-proof bioprocesses with flexible systems that enable companies to respond to changing priorities, new opportunities, and increasing demands. Processes frequently change as a result of new enabling technologies. The advent of single-use systems, perfusion culture, as well as better analytical tools and sensors are just a sampling of the technologies that have changed bioprocessing over the past decade; however, implementing these improvements is not straightforward. Bioprocesses are not always built with the kind of flexibility that allows them to quickly adapt to improvements…

Evolving Beyond the Status Quo with Next Generation Buffer Prep Solutions

In this podcast, we spoke with Chris Rombach, Vice President of Sales and Marketing at Asahi Kasei Bioprocess America about buffer prep and delivery systems. We discussed current pain points and how next generation buffer prep solutions can greatly improve upon the status quo, including increasing the use of automation and remote operation, while reducing the overall footprint, labor and cost associated with more traditional approaches…

Integrated Freezing Solutions to Minimize Risk and Preserve Product Quality

In this podcast, I talked with Claire Jarmey-Swan, Global Product Manager, Pall Corporation about the evolution of freeze-thaw technologies and how these new methods can streamline the process, minimize loss and maintain the highest product quality…

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…

Headlines:

“J&J COVID-19 shot gets better boost from Moderna or Pfizer in NIH study,” Reuters

People who got Johnson & Johnson Inc’s (JNJ.N) COVID-19 vaccine as a first shot had a stronger immune response when boosted with vaccines from Pfizer Inc (PFE.N)/BioNTech SE or Moderna Inc (MRNA.O), a study run by the National Institutes of Health showed on Wednesday. The study, which is preliminary and hasn’t been peer reviewed, is the latest challenge to J&J’s efforts to use its COVID-19 vaccine as a booster in the United States…

“Merck seeks first U.S. authorization for COVID-19 pill,” Reuters

Merck & Co Inc (MRK.N) said on Monday it has applied for U.S. emergency use authorization for its drug to treat mild-to-moderate patients of COVID-19, putting it on course to become the first oral antiviral medication for the disease. An authorization from the U.S. Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home…

“FDA drafts safety reporting guidance for drug and device investigators,” Regulatory Focus

The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting duties for investigational drugs and devices. The draft, published on 29 September 2021, is focused exclusively on the role of investigators – not sponsors – and merges past final guidance from 2009 and 2012 on safety reporting that was previously mixed in with advice to sponsors…

“A ‘Historic Event’: First Malaria Vaccine Approved by W.H.O.,” The New York Times

Malaria kills about 500,000 people each year, about half of them children in Africa. The new vaccine isn’t perfect, but it will help turn the tide, experts said…

“In a first, COVAX to send COVID shots only to least covered nations,” Reuters

A global scheme designed to ensure fair access to COVID-19 vaccines will this month for the first time distribute shots only to countries with the lowest levels of coverage, the World Health Organization said. Co-led by the WHO, COVAX has since January largely allocated doses proportionally among its 140-plus beneficiary states according to population size…

“How exploiting a protective gene mutation might shield the brain from Alzheimer’s disease,” FierceBiotech

Despite the recent introduction of Biogen’s controversial Alzheimer’s disease drug Aduhelm, the work on finding better treatments continues. To help with the search, scientists at the Mayo Clinic have shed light on how a genetic mutation might protect the brain from the neurodegenerative disorder…