This week’s headlines include: U.S. administers 215.9 mln doses of COVID-19 vaccines – CDC, Breakthrough designation granted for Amgen’s bemarituzumab, Abbott Profits Triple As Over-The-Counter Covid Tests Hit Drugstore Shelves, Moderna’s Upcoming Clinical Trials, U.S. to spend $1.7 billion tracking Covid variants as dangerous new strains make up half of all cases, Startup aims to treat Alzheimer’s by invigorating neurons’ garbage-disposal abilities, and Regeneron to request FDA clearance to use Covid antibody drug as a preventative treatment.

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 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.

Virtual event platform is open & live event runs April 27-28. Readers of The Dish can receive a 10% discount if they register with VIP code DISH10 online at https://informaconnect.com/bioprocess-international-covid-19/

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

Enabling process development for continuous bioprocessing: Answering the call for small scale tools that are fit for purpose

In this podcast, we discuss the challenges facing biotech companies as they move their therapeutic candidates through the clinic and on to commercial manufacturing. The priority of speed to market is often at odds with issues around development resources, facility space, and infrastructure for both development and manufacturing. Continuous bioprocessing provides solutions for many of these challenges in certain applications, but to deliver on this promise we need fit-for-purpose tools and technologies to enable process development and provide reliable transfer to commercial manufacturing…

The need of a therapeutic gene editor to develop the next generation of CAR T Therapy

Two chimeric antigen receptor (CAR) T-cell therapies (Kymriah^® and Yescarta^®) are approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to treat B-cell acute lymphoblastic leukemia in children and young adults and diffuse large B cell lymphoma in adults, respectively. Both therapies resulted in high objective response rates (~80% of treated patients) during clinical trials  (Neelapu, 2017) (O’Leary, 2018). Despite these approvals, questions remain over whether cell therapies, such as CAR-T-cells, represent a new era of frontline therapy with potential significance to match that of monoclonal antibodies or whether they will be an effective but niche approach for a narrow range of indications and a relatively small number of patients. This is primarily owing to the challenges encountered when treating patients with solid as opposed to liquid tumors. It is likely that CAR T-cells will need to up their game through genetic engineering if they are to have efficacy in the notoriously immunosuppressive solid tumor microenvironment…

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 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:

“U.S. administers 215.9 mln doses of COVID-19 vaccines – CDC,” Reuters

The United States has administered 215,951,909 doses of COVID-19 vaccines in the country as of Wednesday morning and distributed 277,938,875 doses, the U.S. Centers for Disease Control and Prevention said on Wednesday. Those figures are up from the 213,388,238 vaccine doses the CDC said had gone into arms by April 20 out of 272,030,795 doses delivered…

“Breakthrough designation granted for Amgen’s bemarituzumab,” PharmaTimes Online

Amgen’s investigational medicine bemarituzumab has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). The FDA has granted bemarituzumab a BTD for the first-line treatment of patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) cancer…

“Abbott Profits Triple As Over-The-Counter Covid Tests Hit Drugstore Shelves,” Forbes

Demand for Abbott’s portfolio of tests for Covid-19 continued to drive company profits in the first quarter of this year ahead of the company’s launch of its over-the-counter Coronavirus diagnostics this week in Walmart, Walgreens and CVS drugstores. Abbott, which sells an array of established drugs, medical devices for people with diabetes and diagnostics, said Covid-19 diagnostic-testing related sales were $2.2 billion of the company’s global sales of nearly$10.5 billion in the first quarter…

“Moderna’s Upcoming Clinical Trials,” Seeking Alpha

One of the ways in which this pandemic will be looked back on as a pivot point will (almost certainly) be in the use of mRNA vaccines. It seems clear at this point that these have come through spectacularly against the coronavirus: every new study of their effects in the broad population just adds to the efficacy story, and safety concerns have been minimal. We are extremely fortunate that this is the case – never forget that. The huge amount of work that’s gone into this platform over the years paid off at just the right time for us to quickly get such therapies into human trials, and what’s more, they worked when they got there. That’s not always the case – never forget that, either. Vaccines for infectious disease have a historic two-out-of-three failure rate in the clinic (which is nonetheless the lowest such failure rate by far compared to all other drug development areas!) We had a substantial leg up on the current virus because of all the work that went into SARS and MERS, but even so we’ve seen coronavirus vaccine failures from large, well-resourced, extremely competent outfits like Merck (NYSE:MRK), Sanofi (NASDAQ:SNY), and GSK. There is a timeline in which this happened to everybody, and I’m glad I’m not living in it…

“U.S. to spend $1.7 billion tracking Covid variants as dangerous new strains make up half of all cases,” CNBC

The Biden administration announced Friday it will allocate $1.7 billion toward tracking the highly infectious coronavirus variants that now pose a major threat to the United States’ fight against the pandemic. The funds, taken from the $1.9 trillion Covid relief plan signed into law last month, will be used to help improve the detection, monitoring and mitigation of “new and potentially dangerous strains,” the White House said in a press release…

“Startup aims to treat Alzheimer’s by invigorating neurons’ garbage-disposal abilities,” FierceBiotech

All cells maintain a network of cleaning systems that remove and recycle unwanted proteins. One school of thought holds that when the process, called autophagy, malfunctions in neurons, the toxic buildup of proteins can promote neurodegenerative diseases such as Alzheimer’s…

“Regeneron to request FDA clearance to use Covid antibody drug as a preventative treatment,” CNBC

Regeneron Pharmaceuticals said Monday it will ask the Food and Drug Administration to allow its Covid-19 antibody therapy to be used as a preventative treatment. The therapy, which was given to former President Donald Trump shortly after he was diagnosed with Covid-19 last year, has already been authorized by the FDA to treat adults with mild-to-moderate Covid-19 and pediatric patients at least 12 years of age who have tested positive for the virus and are at high risk of severe disease…