This week’s headlines include: J&J COVID-19 vaccine in limbo as U.S. panel delays vote on resuming shots, Tango finds a quick step to Wall Street via $353M SPAC deal, Pfizer to deliver 10% more doses to U.S. by end of May- CEO, Biden Trade Chief Meets Drugmakers, WTO Vaccine-Waiver Advocates, Regeneron to seek U.S. OK for COVID-19 cocktail to be used for prevention, EU nod for new formulation of Biogen’s Tysabri, and Sanofi to invest 400 mln euros in new vaccine production site in Singapore.

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.  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:

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:

“J&J COVID-19 vaccine in limbo as U.S. panel delays vote on resuming shots,” Reuters

Johnson & Johnson’s COVID-19 vaccine remained in limbo on Wednesday evening as a U.S. health panel called for more data before making a decision on how and whether to resume use of the one-dose shot, putting off a vote for a week or more. The U.S. Centers for Disease Control and Prevention (CDC) advisory panel decided to delay a vote on how best to use the J&J shot even after a U.S. Food and Drug Administration scientist told advisers he believed warnings could mitigate the risk of extremely rare but serious blood clots…

“Tango finds a quick step to Wall Street via $353M SPAC deal,” Fierce Biotech

Tango Therapeutics is aiming for the public markets, one year after raising its latest private round. But instead of going the traditional IPO route, the synthetic lethality biotech is joining a swelling wave of life sciences companies that are hitting Wall Street by merging with a special purpose acquisition company, or SPAC, raising $353 million in the process…

“Pfizer to deliver 10% more doses to U.S. by end of May- CEO,” Reuters

Pfizer Inc (PFE.N) can deliver 10% more doses of its COVID-19 vaccine to the United States by the end of May and meet its target of supplying 300 million doses two weeks earlier than expected, Chief Executive Officer Albert Bourla said in a tweet on Tuesday. Pfizer had promised to provide the U.S. government with 100 million doses by the end of March and another 100 million by the end of May, with the rest being delivered by the end of July…

“Biden Trade Chief Meets Drugmakers, WTO Vaccine-Waiver Advocates,” Bloomberg

President Joe Biden’s trade chief met with drugmakers and with groups seeking a waiver for sections of the World Trade Organization’s intellectual-property rules to improve vaccine access for poorer nations. U.S. Trade Representative Katherine Tai held three separate meetings on Tuesday, according to statements from USTR. One was with civil-society organizations including Public Citizen and Human Rights Watch, and another with labor groups such as the United Steelworkers and American Federation of Teachers. Later, she met with business leaders in PhRMA, the biopharma industry’s lobbying group, and the Biotechnology Innovation Organization, another industry trade group…

“Regeneron to seek U.S. OK for COVID-19 cocktail to be used for prevention,” Reuters

Regeneron is pursuing U.S. approval for its COVID-19 monoclonal antibody cocktail as a preventative treatment after it helped cut the risk of symptomatic infections in households where someone else is ill, the U.S. drugmaker said on Monday. REGEN-COV, a combination of casirivimab and imdevimab, protected household contacts from exposure to SARS-CoV-2, with 72% protection against symptomatic infections in the first week, and 93% after that, according to trial data released by the company…

“EU nod for new formulation of Biogen’s Tysabri,” PharmaTimes Online

European regulators have approved Biogen’s application to market a subcutaneous (SC) injection of Tysabri (natalizumab) to treat relapsing-remitting multiple sclerosis (MS). The new formulation offers comparable efficacy and safety to intravenous (IV) Tysabri, and makes the drug the only high-efficacy MS therapy to offer two routes of administration…

“Sanofi to invest 400 mln euros in new vaccine production site in Singapore,” Reuters

French drugmaker Sanofi (SASY.PA) said on Monday it would invest 400 million euros ($475.40 million) over five years in a new vaccine production site in Singapore. The new site would provide Sanofi with the ability to produce innovative vaccines on a massive scale for Asia and respond to future pandemic risks, the company said in a statement…