This week’s headlines include: Pfizer COVID-19 vaccine can be stored in refrigerator for a month, Bristol Myers hands over $200M upfront, $1.36B in biobucks for Agenus’ preclinical TIGIT asset, Positive mid-stage results for Medicago and GSK’s plant-derived COVID-19 vaccine,Gamma Biosciences Acquires Controlling Stake in Mirus Bio to Expand Reach in Gene Therapy and Next Generation Vaccines, Biden to send 20 mln doses of U.S.-authorized vaccines abroad for first time, Autolus’ CD19 CAR-T posts 100% complete response rate, zero grade 3 CRS in small lymphoma trial, and Univercells Technologies Collaborates with NIBRT.

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:

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…

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…

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…

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:

“Pfizer COVID-19 vaccine can be stored in refrigerator for a month, U.S. says,” Reuters

The U.S. Food and Drug Administration on Wednesday authorized storage of Pfizer Inc (PFE.N) and German partner BioNTech SE’s (22UAy.DE) COVID-19 vaccine at standard refrigerator temperatures for up to one month, in an effort to make the vaccine more widely available. Unopened, thawed vials of the vaccine can be stored in a refrigerator at 2 to 8 degrees Celsius for up to a month, up from a previous maximum limit of five days…

“Bristol Myers hands over $200M upfront, $1.36B in biobucks for Agenus’ preclinical TIGIT asset,” FierceBiotech

The headline hopeful is its preclinical TIGIT candidate, AGEN1777, currently in the later stages of preclinical development, with an IND for a clinical trial expected imminently. BMS also nabs rights to “a second undisclosed target” but gave no details on that. TIGIT, or T-cell immunoreceptor with immunoglobulin and ITIM domain, is a promising new target for cancer immunotherapy and is upregulated by immune cells including activated T cells, natural killer cells and regulatory T cells…

“Positive mid-stage results for Medicago and GSK’s plant-derived COVID-19 vaccine,” PharmaTimes Online

Medicago and GlaxoSmithKline’s (GSK) plant-derived COVID-19 vaccine has generated some promising mid-stage trial results, the companies revealed today. Interim results from a Phase II trial evaluating the vaccine candidate, which is being tested in combination with GSK’s pandemic adjuvant, found that neutralising antibody responses were ten times higher in vaccinated participants compared to people recovering from COVID-19…

“Gamma Biosciences Acquires Controlling Stake in Mirus Bio to Expand Reach in Gene Therapy and Next Generation Vaccines,” PR Newswire

Gamma Biosciences, a global life sciences company serving the advanced therapy market, today announced that it has agreed to make a controlling investment in Mirus Bio, an innovator and developer of biomimetic, cell-adaptive lipid-polymer nanocomplexes (LPNCs) for nucleic acid delivery based in Madison, Wisconsin. Current Mirus shareholders will retain a substantial equity ownership stake in the company. The transaction will support Mirus’ plans to expand good manufacturing practice (GMP) production and commercialization of its flagship product TransIT® VirusGEN for large scale manufacturing of AAV and LV-based viral vectors for gene therapy, as well as further development and commercialization of the platform for in vivo delivery applications. Originally developed for therapeutic delivery of RNA, Mirus LPNCs have been adapted for a wide range of gene delivery applications. Demand for efficient and scalable gene delivery technologies continues to increase as larger volumes of viral vector are required to support the growing number of gene therapies in development. TransIT® VirusGen and Mirus’ portfolio of additional products and services enable customers at both research and clinical scales achieve cost effective, industry leading functional titers…

“Biden to send 20 mln doses of U.S.-authorized vaccines abroad for first time,” Reuters

President Joe Biden will send at least 20 million more COVID-19 vaccine doses abroad by the end of June, marking the first time the United States is sharing vaccines authorized for domestic use. The move marks a notable pivot from the White House as the administration seeks to use the country’s vaccine supply as a diplomatic tool with the pandemic outlook brightening at home…

“Autolus’ CD19 CAR-T posts 100% complete response rate, zero grade 3 CRS in small lymphoma trial,” FierceBiotech

Autolus Therapeutics has linked its CD19 CAR-T to a 100% complete response rate in a small indolent B-cell lymphoma trial. AUTO1 drove the responses without causing any grade 3 or worse cytokine release syndrome (CRS), sending shares in the biotech up 35%. The results, full details of which Autolus will share at the European Hematology Association Virtual Congress next month, come from nine adults with relapsed or refractory low grade B-cell lymphoma despite high disease burden. All patients went into complete remission. No patients suffered grade 3 CRS, and only one participant had a grade 2 cytokine reaction. There were four cases of grade 1 CRS…

“Univercells Technologies Collaborates with NIBRT,” ContractPharma

Univercells Technologies, a global provider of next-generation biomanufacturing technologies, and the National Institute of Bioprocessing Research and Training (NIBRT) in Dublin, Ireland, are collaborating to address the need for training in cell and gene therapies (CGTs) using next-generation technologies for viral products manufacture. The intermediate capacity scale-X carbo system from Univercells Technologies, featuring a fixed-bed bioreactor and in-line concentration, will be introduced at the Dublin facility for hands-on demonstration and training to support continued education and workforce sustainability…