The Dish’s Weekly Biotechnology News Wrap Up – June 11, 2021
This week’s headlines include: US has bought and will donate 500 million doses of Pfizer’s vaccine worldwide, FDA approves much-debated Alzheimer’s drug panned by experts, A New Type Of COVID-19 Vaccine Could Debut Soon, U.S. authorizes Regeneron’s COVID-19 antibody therapy for injection, ASCO: Gilead’s Kite soars over Novartis’ CAR-T turf with Tecartus win in type of leukemia, AstraZeneca’s Lynparza reduces relapse, death in breast cancer patients, and Moderna plans mix of COVID-19 vaccine doses with new Lonza deal.
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:
World Biopharm Forum 2021
Following on from their successful conference “Continuous Biomanufacturing: Driving value through intensified bioprocessing”, World Biopharm Forum is hosting the 2021 conference “Value Through Intensified Process II” to be held at Lady Margaret Hall, University of Oxford, UK on the 1st-3rd September 2021.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Simplifying CHO Fed-Batch and Perfusion Culture Media Evaluation from Expansion to Production
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…
Media panels for AAV manufacturing: Finding the formulation for success
Gene therapies show great potential in the treatment of a variety of currently incurable genetic diseases. While viral vectors are the preferred method for gene delivery, their cGMP production has also created a bottleneck in the industry. The answer to this bottleneck is to increase viral vector titers and reduce operating footprint. For adeno-associated virus (AAV), this involves an industry move toward the use of suspension HEK293 cell lines…
Recombinant Human Serum Albumin Excipient – Regulatory Filing and Approval for Use in Vaccine Manufacturing
During the 2020 Excipient World Conference & Expo, supported by IPEC-Americas, Kara Quinn, the Associate Director of Engineering for Merck & Co, presented a webinar detailing the first-hand account of the complex process of regulatory agency filing that led to the regulatory approval, by both the FDA and EMA, for the use of a novel excipient, Exbumin™, in the manufacture of their first-in-class Ebola vaccine ERVEBO®…
Ask the Expert – Transfection Best Practices for AAV Gene Therapy
The majority of vectors used for gene therapies are currently generated using transient production systems, primarily due to convenience and speed of process. Manufacturing viral vectors via transfection is flexible and efficient and does not require time consuming development of stable cell lines. However, transfection based methods do require optimization to ensure the highest productivity, consistency between batches, and scalability…
Get hassle-free AAV titer and empty/full characterization on Stunner
In this mini-webinar and accompanying article, Kevin Lance, PhD, Marketing Manager at Unchained Labs, shares how to obtain AAV titer and empty/full characterization quickly and efficiently with only a small amount of sample required…
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 has bought and will donate 500 million doses of Pfizer’s vaccine worldwide,” CNN
The US has purchased and will donate 500 million doses of Pfizer’s Covid-19 vaccine worldwide as it seeks to be a key player in getting other nations vaccinated, a person familiar with the move told CNN. President Joe Biden will announce the news at the G7 summit in Cornwall, England, this week, the person said…
“FDA approves much-debated Alzheimer’s drug panned by experts,” Associated Press
Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. The Food and Drug Administration approved the drug from Biogen based on study results showing it seemed “reasonably likely” to benefit Alzheimer’s patients. It’s the only therapy that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia…
“A New Type Of COVID-19 Vaccine Could Debut Soon,” NPR
A new kind of COVID-19 vaccine could be available as soon as this summer. It’s what’s known as a protein subunit vaccine. It works somewhat differently from the current crop of vaccines authorized for use in the U.S. but is based on a well-understood technology and doesn’t require special refrigeration…
“U.S. authorizes Regeneron’s COVID-19 antibody therapy for injection,” Reuters
The U.S. health regulator authorized a lower dose of Regeneron Pharmaceutical’s COVID-19 antibody cocktail that can be given by injection, a move that could ease logistical challenges stemming from administering a higher dose intravenously. The therapy, REGEN-COV, and a similar treatment developed by rival Eli Lilly (LLY.N) were being given through one-time infusion and required patients to be isolated…
“ASCO: Gilead’s Kite soars over Novartis’ CAR-T turf with Tecartus win in type of leukemia,” FiercePharma
In 2017, Novartis’ Kymriah became the first CAR-T therapy approved by the FDA with a go-ahead in acute lymphoblastic leukemia. For the following years, its close rival, Gilead Sciences’ Kite Pharma, didn’t enter the field, but that may soon change…
“AstraZeneca’s Lynparza reduces relapse, death in breast cancer patients,” Reuters
AstraZeneca Plc’s (AZN.L) drug Lynparza reduced the risk of relapse and death in breast cancer patients with certain mutations in a late-stage trial, the British drugmaker said on Thursday. The results, published in The New England Journal of Medicine, showed that the drug reduced the combined risk of recurrence of cancer or death from any cause by 42% compared to a placebo…
“Moderna plans mix of COVID-19 vaccine doses with new Lonza deal,” Reuters
Moderna is gearing up to halve the dose of its COVID-19 vaccine, the U.S. drugmaker said on Wednesday, so that it can also be used to combat variants and inoculate children. It has agreed a deal with Swiss-based drugmaker Lonza (LONN.S) which said a new drug substance production line in Geleen, Netherlands, will have capacity to make ingredients for up to 300 million doses annually at 50 micrograms per dose…