The Dish’s Weekly Biotechnology News Wrap Up – June 5, 2020

June 05, 2020 Written by Brandy Sargent

This week’s headlines include: Trump administration selects five coronavirus vaccine candidates as finalists: NYT, Fauci: Moderna’s Phase 3 Covid-19 Vaccine Trial Of 30,000 Individuals Will Begin In July, Gilead’s next step on coronavirus: inhaled remdesivir, other easier-to-use versions, Hahn: FDA will make some changes amid COVID-19 permanent, Exclusive: Lonza sets new goal to make Moderna COVID-19 vaccine ingredients, Pfizer to invest up to $500 million in small and medium-sized biotech companies, U.S. awards new $628 million contract to boost output of potential COVID-19 vaccine, Lilly’s Cyramza, after split decision from FDA advisers, wins first-line lung cancer nod, Eli Lilly Begins Testing Covid-19 Drug Derived From Blood of Survivor, Pharma leaders shoot down WHO voluntary pool for patent rights on Covid-19 products, and FDA explains impact of COVID-19 on applications, formal meetings.

Podcasts:

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Webinars:

Harnessing the Power of Protein Expression Systems in Vaccine Development

Available On-Demand

In just a few months COVID-19 has risen from a regional crisis to a global threat, and drug makers are now scrambling to develop vaccines aimed at thwarting a pandemic. To meet this urgent and life-threatening situation, vaccine developers are actively seeking the most efficient and robust production platforms to accelerate development timelines. Throughput, productivity, and scalability of the expression platform as well as the availability of well-documented production cell lines are key selection criteria when initiating a vaccine development campaign under such urgent circumstances. To this end, the Gibco Expi Expression Systems are complete platforms that can accelerate vaccine development by enabling rapid, high-yield, and scalable production of proteins, viral antigens and viral-like particles from mammalian (ExpiCHO and Expi293) and insect (ExpiSf) cells. By providing flexible and highly productive expression systems for three different cell hosts that employ optimized and chemically defined components, the Expi systems support every stage of vaccine development. This unified, end-to-end approach reduces key product quality risks during development as one can use the same cell line from research to large-scale production while streamlining process development by utilizing integrated reagents for unmatched performance.

Learning Objectives:

Understand how to accelerate vaccine development timelines
Discover new technologies for rapid, high-yield, and scalable production of proteins, viral antigens, and viral-like particles

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

Multistem – A Stable, Off-the Shelf Regenerative Medicine Has Demonstrated Promise in Treating Patients with Acute Respiratory Distress Syndrome or ARDS

In this podcast and accompanying article, we talked with Dr. Gil Van Bokkelen, Chairman and CEO, Athersys about recent clinical breakthroughs in regenerative medicine and manufacturing challenges. We also discussed Multistem and how it has been demonstrated to help patients with ARDS (Acute Respiratory Distress Syndrome)…

3D Model Systems: Spheroids, Organoid and Tissue Model Systems

Here, we look to demystify Spheroid and Organoids and discuss the distinct differences between them and their utility in scientific research as well as more advanced 3D tissue model systems like organ-on-a-chip technology…

COVID-19 Therapeutics in Clinical Trials: The Antivirals

As the SARS-CoV-2 pandemic spreads around the world in early 2020, scientists, doctors, and clinicians are rushing 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. Due to the magnitude of the effort by the medical community, it is difficult to keep track of the numerous therapeutic approaches. We scanned clinicaltrials.gov and found roughly 50 medications, world-wide, that have been in trial, currently are in trial, or are soliciting applicants for study. The medications include a broad array of activities which include antivirals, antiviral cell mediators, immunomodulators, and others. They are being evaluated singly, or in combinations, and usually across multiple clinical sites…

Bi-Specific Antibodies – The development, manufacture and promise of these cutting-edge therapeutics

In this podcast, we conducted a panel discussion with experts from Selexis and KBI Biopharma on bi-specific antibodies. We examined bi-specific antibody development and manufacturing, including current challenges and key solutions. We also discussed the promise of these cutting-edge therapeutics and their future in medicine…

Rapid At-line Media Analyzer Speeds Process Development by Eliminating Analytics Bottleneck

In this podcast, we talked with Dr. Glenn Harris, Director of Integrated Life Sciences Platforms at 908 Devices, about the benefits and challenges of implementing rapid media analysis in process development, including the bottleneck created by outsourcing samples to core labs. We also discussed an easy to implement, benchtop media analyzer that permits comprehensive media analysis in real-time, thus speeding process development efforts…

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…

Innovative Single-Use Freeze and Thaw Platform for Bulk Drug Substance

Successful bulk drug substance freeze and thaw is a critical aspect of biologics manufacturing. It is also time consuming and labor intensive. Historically, cryovessels have been the most common technology used for freeze and thaw due to their durability and scalability. However, cryovessels require extensive cleaning processes and infrastructure and labor to maintain them. These challenges, led companies to look for single-use alternatives. While single-use significantly reduces cleaning requirements, they are difficult to scale due to limitations of the size of the bags. Another downside is that they can be prone to integrity issues…

Automated Buffer Preparation – Increasing Production Capacity While Maintaining Footprint

Buffer preparation requires extensive footprint and is also resource-intensive. In fact, it is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required as production capacity increases. Thus the question exists how can buffer preparation be more efficient and not require footprint expansion. Is there a way to increase manufacturing capacity without increasing footprint and time spent on buffers? One possible solution is automating buffer preparation and I am pleased to share the following guest blog that discusses the advantages and addresses concerns about moving from manual to automated buffer preparation. I was fortunate to be able to interview the author about his article and have provided the transcript of our conversation following the guest blog…

Viral Filtration Validation Study Design – A Systematic Method for Choosing the Most Appropriate Test Approach

Viral filter validation is important to ensure the removal of viruses under the conditions seen at process scale when using scale-down models. When designing an effective study, there are key components that must be decided on. First, it is important to select a virus spike level that will allow for quantification of virus removal, without having a negative impact on the scaled down process. Second, it is important to understand how a virus prefilter will be incorporated into the study design…

Headlines:

“Trump administration selects five coronavirus vaccine candidates as finalists: NYT,” Reuters

The Trump administration has selected five companies, including Moderna Inc, AstraZeneca Plc and Pfizer Inc, as the most likely candidates to produce a vaccine for the novel coronavirus, the New York Times reported on Wednesday, citing senior officials…

“Fauci: Moderna’s Phase 3 Covid-19 Vaccine Trial Of 30,000 Individuals Will Begin In July,” Forbes

Dr. Anthony Fauci said the Phase 3 trial of Moderna’s experimental COVID-19 vaccine will begin in July and include study of 30,000 patients who will be as young as 18 and include elderly Americans as well…

“Gilead’s next step on coronavirus: inhaled remdesivir, other easier-to-use versions,” Reuters

Gilead Sciences Inc (GILD.O) is developing easier-to-administer versions of its antiviral treatment remdesivir for COVID-19 that could be used outside of hospitals, including ones that can be inhaled, after trials showed moderate effectiveness for the drug given by infusion…

“Hahn: FDA will make some changes amid COVID-19 permanent,” Regulatory Focus

The US Food and Drug Administration (FDA) will look to permanently implement some of the processes and policies adopted in its response to the coronavirus disease (COVID-19) pandemic, FDA Commissioner Stephen Hahn said during a virtual briefing hosted by the Alliance for a Stronger FDA on Monday…

“Exclusive: Lonza sets new goal to make Moderna COVID-19 vaccine ingredients,” Reuters

Lonza aims to speed completion of two commercial production lines for Moderna Inc’s trial COVID-19 vaccine so manufacturing could start four to six weeks earlier than planned if the project is successful, the Swiss drugmaker’s chairman said on Tuesday…

“Pfizer to invest up to $500 million in small and medium-sized biotech companies,” MarketWatch

Pfizer Inc. said Tuesday it is planning to invest up to $500 million in biotech companies to support the sector’s most promising clinical development programs. “There has never been a more important moment to pursue new collaborations in our industry,” said John Young, Pfizer’s chief business officer, as he unveiled the Pfizer Breakthrough Growth Initiative. The program will focus on small to medium-sized biotech company in the areas of internal medicine, inflammation and immunology, oncology, rare disease, vaccines and hospital. Pfizer shares rose 1.2% in premarket trade, but are down 9% in the year to date, while the S&P 500 has fallen 5% and the Dow Jones Industrial Average has fallen 11%…

“U.S. awards new $628 million contract to boost output of potential COVID-19 vaccine,” Reuters

The U.S. government on Monday entered into a $628 million contract with drugmaker Emergent BioSolutions (EBS.N) to boost manufacturing capacity for a potential COVID-19 vaccine…

“Lilly’s Cyramza, after split decision from FDA advisers, wins first-line lung cancer nod,” FiercePharma

When an FDA advisory panel narrowly backed Eli Lilly’s Cyramza for use in newly diagnosed non-small cell lung cancer (NSCLC), a final approval didn’t seem so certain. Now, the company can breathe a sigh of relief, as the agency has decided to follow the experts’ recommendation…

“Eli Lilly Begins Testing Covid-19 Drug Derived From Blood of Survivor,” The Wall Street Journal

Eli Lilly & Co. said Monday it began the first study of an experimental drug derived from a blood sample of an early U.S. survivor of Covid-19, a new effort to take advantage of the molecular defenses developed by recovered patients…

“Pharma leaders shoot down WHO voluntary pool for patent rights on Covid-19 products,” STAT

The heads of some of the world’s largest drug makers expressed a mix of confusion and resistance to a World Health Organization voluntary pool to collect patent rights, regulatory test data, and other information that could be shared for developing Covid-19 therapies, vaccines, and diagnostics…

“FDA explains impact of COVID-19 on applications, formal meetings,” Regulatory Focus

The US Food and Drug Administration (FDA) on Tuesday issued immediately effective guidance explaining how the coronavirus disease (COVID-19) public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications…

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