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Vaccine Manufacturing: Chasing COVID’s Long Tail

January 31, 2022

By Mid-December 2021, the RAPS (Regulatory Affairs Professionals Society) COVID-19 Vaccine Tracker listed 91 active COVID-19 candidates in development around the globe. That’s in addition to the 25 vaccine products already approved by various international regulatory authorities.

Just months ago, one might have questioned the business case for jumping into – or even remaining in – that crowded race.

Then, along came Delta. And Omicron after that. And then the ensuing questions—and lack of immediate answers—about the Moderna, Pfizer, and J&J products’ efficacy against mutations, or how many doses of each it might take to achieve protection from these emerging variants. And the next one. And the one after that. Because the next mutation isn’t an if proposition so much as a question of when it’s detected. It’s already out there, somewhere.

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Why Biopharma Should Consider Plant-Based Manufacturing

August 4, 2021

As I wrote last month, using plant cells to make biopharmaceuticals is not a new idea. However, while several plant-made biopharmaceuticals, including treatments for diabetes, hepatitis, and an Ebola vaccine, have been approved, the vast majority are still produced in cells culture in bioreactors.

And this means biopharma is missing out according to Randy Maddux, COO of iBio, who cites scalability, the absence of mammalian viruses as well as cost reduction as advantages of a plant-based expression system.

“Cost advantages come in the form of lower CapEx to build the upstream, and lower overall company costs to go from hit to IND, given months are saved as we take manufacturing off of the critical path,” he says. “The speed advantage to manufacturing GMP material will get new medicines to patients faster.

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Plant-based production of antifibrotic peptides receives U.S. patent

January 30, 2021

Scarring, or fibrosis, can lead to organ failure and is the end stage of many diseases, including lung, liver and heart disease. Before coming to MUSC, Carol Feghali-Bostwick, Ph.D., the Kitty Trask Holt Endowed Chair for Scleroderma Research and a professor of medicine, identified antifibrotic properties of a peptide that not only stopped fibrosis but reversed it in mice and cultured human tissue.

The peptide was licensed to iBio Inc., a biologics company that develops therapeutics in plants. Since then, iBio has been producing the protein using a plant-based system. In November 2020, MUSC, iBio and Novici Biotech received a U.S. patent on plant-based production for the peptide that is being developed by iBio. This novel production method is inexpensive and should ensure an adequate supply of the peptide for clinical trials and later for clinical use.

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Customized Glycoengineering in Plant-Based Expression Systems

January 8, 2021

The past few years have seen an explosion in interest in immuno-oncology approaches that leverage monoclonal antibodies (mAbs) as therapeutics for a range of cancers. These therapies take advantage of the ability of antibodies to trigger antibody-dependent cellular cytotoxicity (ADCC) within the innate immune response, in which the patient’s immune cells (predominantly natural killer T cells) respond to the binding of the mAb to antigens on the surfaces of cancer cells by actively lysing the cancer cells.

Recent research has shown that the glycosylation state of therapeutic antibodies––particularly fucosylation––can modulate the activity of the antibodies and thus the robustness of the ADCC response. The Fc region of mAbs functions as a critical bridge between the adaptive and innate immune response, notably including the activation of ADCC via natural killer Tcells.

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Exploring Plant-Based Bioreactors for Developing COVID-19 Therapeutics and Vaccines

October 2, 2020

Biologics company iBio, is focused on developing therapeutics and vaccines using a novel plant-based system. It recently announced a worldwide licensing agreement with Planet Biotec> to develop and manufacture a novel COVID-19 therapeutic calledACE2-Fc.

Technology Networks spoke with iBio’s CEO and Chairman of the Board Thomas Isett, to learn more about the company’s efforts to develop ACE2-Fc as well as two vaccine candidates IBIO-200 and IBIO-201 against SARS-CoV-2. Isett also discusses the key benefits of plant-based manufacturing and highlights additional disease areas that they are working to develop biotherapeutics for.

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