This week’s headlines include: US backs waiving intellectual property rules on vaccines, Canada authorizes COVID-19 vaccine for adolescents, Novavax expands COVID-19 vaccine study to include adolescents, Congo declares end of Ebola outbreak that killed six, FDA scraps another last-minute Trump-era policy, Novavax handed an extra $147M from legacy Warp Speed program as spotlight shines brighter, and Boundless Bio corrals $105M financing round to prep aggressive cancer programs for clinic.

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

Ask the Expert – Using Disease Models at the Air Liquid Interface to Advance Respiratory Disease Studies

Air-liquid Interface (ALI) is ideal for studying respiratory tract epithelial cells because it exposes one side of the culture to liquid media and surrounds the other with air. ALI systems therefore allow researchers to more accurately mimic in vivo conditions compared to using conventional cell culture models. This makes them ideal to perform mechanistic studies of respiratory epithelial cells as drug permeation barriers; to model respiratory diseases like cystic fibrosis and asthma; to investigate essential dermal processes such as wound healing; and to advance understanding of respiratory epithelium infections including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). From asthma to COPD, ALI models have been critical in researching respiratory diseases. With the recent outbreak and severity of the COVID-19 virus, this technology is becoming even more critical in the race to understand and treat disease.

With the popularity of these more complex models growing, we have assembled a team of experts to answer your questions on disease modeling using ALI tools and systems. Session opens for questions on Monday!

Conferences:

World Biopharm Forum 2021

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

Proteogenomic Strategies to accelerate Drug Discovery and Increase Success

There are countless diseases that are in desperate need of new, more effective therapeutics to address unmet needs or to improve current standards of care. Addressing these needs is no easy task considering the long timeline to approve new drugs coupled with how few drugs successfully make it through clinical trials in the first place. The challenges of moving a therapeutic candidate through clinical trials was highlighted in the report Biopharmaceutical Research & Development: The Process Behind New Medicines, published by PhRMA. In the report authors’ state that the process for researching and developing new medicines is growing in difficulty and length with the overall probability of clinical success estimated to be less than 12%…

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…

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…

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:

“US backs waiving intellectual property rules on vaccines,” The Associated Press

The Biden administration on Wednesday joined calls for more sharing of the technology behind COVID-19 vaccines to help speed the end of the pandemic, a shift that puts the U.S. alongside many in the developing world who want rich countries to do more to get doses to the needy. U.S. Trade Representative Katherine Tai announced the government’s position, amid World Trade Organization talks about a possible temporary waiver of its protections that would allow more manufacturers to produce the life-saving vaccines…

“Canada authorizes COVID-19 vaccine for adolescents,” The Hill

Canada on Wednesday became the first country to open up coronavirus vaccinations for adolescents by authorizing the use of the Pfizer-BioNTech coronavirus vaccine for residents ages 12 to 15. The Canadian health department announced the move in a press release, which comes just weeks after the government received an application to expand the vaccine to the younger age group…

“Novavax expands COVID-19 vaccine study to include adolescents,” Reuters

Novavax Inc said on Monday it had expanded the late-stage study testing its COVID-19 vaccine candidate to include up to 3,000 adolescents aged 12 to 17. Rivals Moderna Inc and Pfizer Inc are also testing their COVID-19 vaccines in younger age groups. Moderna’s vaccine is authorized for emergency use in the United States in adults aged 18 or above, while Pfizer’s shot is authorized for use in people aged 16 and above…

“Congo declares end of Ebola outbreak that killed six,” Reuters

The Democratic Republic of Congo on Monday declared the end of an Ebola outbreak that infected 12 people in the eastern province of North Kivu and killed six of them. The outbreak was contained using Merck’s (MRK.N) Ebola vaccine, which was given to more than 1,600 of the patients’ contacts and contacts of contacts, the aid group Medecins Sans Frontieres (MSF), said…

“FDA scraps another last-minute Trump-era policy,” Regulatory Focus

The US Food and Drug Administration (FDA) on Friday revoked a policy issued in the final days of the Trump administration that was purportedly aimed at increasing transparency related to drug review timelines. The policy, announced by the Department of Health and Human Services (HHS) on 15 January 2021, would have required FDA to publish “redundant” information on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the agency for review…

“Novavax handed an extra $147M from legacy Warp Speed program as spotlight shines brighter,” FierceBiotech

A biotech with a long and often troubled past is hoping 2021 will be its year, and it’s just been handed a major tranche of cash to help make that happen. Novavax has been in existence for more than 30 years but has never seen an approved product and has been close to having to turn the lights off and call it a day a few times. Then, COVID-19 came along and changed its fortunes, quite literally. It was handed millions to get on with vaccine trials against the virus last year, and now, according to a Securities and Exchange Commission filing, the Operation Warp Speed pact is still handing over cash: The company was given an additional $147.34 million, bringing its total from the program to $1.74 billion…

“Boundless Bio corrals $105M financing round to prep aggressive cancer programs for clinic,” FierceBiotech

Boundless Bio has wrapped a $105 million series B financing to launch the company’s extrachromosomal DNA (ecDNA) programs for aggressive cancers into the clinic. The financing was co-led by RA Capital Management and Nextech Invest and also included Fidelity Management & Research Company LLC, Redmile Group, Wellington Management and others. Launched in 2019, Boundless is developing precision oncology drugs targeting ecDNA cancers that have resisted treatment. Since raising $46 million in a Series A, Boundless has quietly been working on its tech and has singled out three targets through a custom platform called Spyglass…