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IBIO Molecular Farming Manufacturing Possibilities in South Africa
https://rybicki.blog/2020/04/04/plant-made-vaccines-and-reagents-for-sars-cov-2-in-south-africa/

Our group in the BRU, our recent spinout partners* Cape Bio Pharms, and a group at the SA Council for Scientific and Industrial Research (CSIR) are the three premier molecular farming research and development teams in South Africa. We have jointly made a host of candidate vaccines, virus-derived reagents for use in molecular biology labs and in diagnostics, and mAbs for use as reagents and potentially as therapeutics. Presently, Cape Bio Pharms and possibly the CSIR represent the only pilot-scale manufacturing facilities in South Africa for plant-made biologics, despite initiatives over years involving us and the CSIR and various government departments. A symposium in Franschhoek in the Western Cape Province in November 2017, hosted by the BRU and by iBio Inc of Bryan Texas, pitched a plan to assembled invited delegates for public/private partnership to construct a facility in this country to make pharmaceutical products using molecular farming technology. In announcing it, we said the following
Quote:
“The conference brings together leaders from public agencies, academic institutions, parastatals, private companies, regulators and private capital to map out concrete steps to establish the plant-based manufacturing platform in South Africa. The Department of Science and Technology (DST) leads a broad science and technology innovation effort including of advanced health care products to create socio-economic opportunities. The Technology Innovation Agency (TIA) is an active funder of human and animal health care initiatives in South Africa. The Industrial Development Corporation (IDC) is a primary developer of manufacturing capacity and has important initiatives in biotechnology. Other participating agencies include the Council for Scientific and Industrial Research (CSIR), with its own molecular farming pipeline, and the Department of Trade and Industry (DTI).

AzarGen Biotechnologies is a private South African biotechnology company will be part of the private sector representation. AzarGen, primarily funded by the IDC, has worked with iBio for the last three years to develop biotherapeutics that include surfactin for infant respiratory distress syndrome and a biobetter rituximab monoclonal antibody for the treatment of non-Hodgkin’s lymphoma and certain autoimmune diseases. The BioVac Institute and Onderstepoort Biologicals, manufacturers of human and animal vaccine products respectively, will also present. ENSafrica will speak to Intellectual Asset Management and Cape Venture Partners will overview the private capital opportunities in South Africa. Technology Innovation Group, a US based consulting group, will talk about the structure of successful public/private partnerships.”
While the idea of a full-scale facility similar to iBio’s – costed at around USD30 million/R450 million – did not appeal to funders present, the idea of a cGMP-certified pilot manufacturing facility costing USD10 million – R150 million at the time – constructed using iBio’s expertise and assistance, found more favour. In fact, various entities promised to survey interested parties to establish the need and feasibility of internally funding it.

To the best of my knowledge, nothing along the lines of a survey has happened to date. Since then, and in the absence of any apparent interest from what were DST, DTI, IDC, TIA and others, iBio has gone on in 2019 to announce a partnership with Azargen in the area of rituximab biosimilar production, and as of a few days ago, as a contract manufacturing organisation, is offering their services in making COVID/SARS2 reagents at industrial scale in plants. Cape Bio Pharms has also established itself as a reagent manufacturer independently of any outside associations, with only local investment and a THRIP grant from Dept of Trade and Industry (DTI). I note that a previous proposal from some years ago involving the CSIR and Kentucky BioProcessing for establishment of an even cheaper pilot facility, also fell flat. For comparison, I will point out that the cost of just the revamping of Onderstepoort Biological Products’ (OBP, SA’s premier veterinary vaccine manufacturer) facility to be able to achieve cGMP certification is estimated to be ~R500 million.

About iBio Inc
iBio is a global leader in plant-based biologics manufacturing. Its FastPharming System™ https://www.ibioinc.com/technology/fastpharming combines vertical farming, automated hydroponics, and glycan engineering technologies to rapidly deliver gram quantities of high-quality monoclonal antibodies, vaccines, bioinks and other proteins. The Company’s subsidiary, iBio CDMO LLC, provides FastPharming Contract Development and Manufacturing Services via its 130,000 square foot facility in Bryan, Texas.

Originally built in 2010 with funding from the U.S. Defense Advanced Research Projects Agency (DARPA), iBio’s FastPharming Facility was part of the “Blue Angel” initiative to establish factories capable of rapid delivery of medical countermeasures in response to a disease pandemic. iBio’s FastGlycaneering Development Service™ https://www.ibioinc.com/technology/glycan-engineering includes an array of new glycosylation technologies for engineering high-performance recombinant proteins. Additionally, iBio is developing proprietary products which include IBIO-100 for the treatment of fibrotic diseases and IBIO-200, a COVID-19 vaccine. For more information, visit https://www.ibioinc.com/.





iBio Inc COVID-19 Vaccine Program
Immunization studies for its SARS-CoV-2 Virus-Like Particle (“VLP”) program (“IBIO-200”) are proceeding at Texas A&M University System (“TAMUS”) laboratories. The work is being performed as part of the Master Joint Development Agreement established between iBio and TAMUS in 2016. Tom Isett, Co-Chairman & Chief Executive Officer of iBio, said:
Quote:
“This next stage of work on IBIO-200 is critically important as we seek to quickly enter the clinic with one of our VLP candidates. As we optimize our choice of adjuvants with both VLP types we have developed, we are fortunate to have a strong relationship with TAMUS that allows us to rapidly bring their deep insight into the pathogenesis of coronaviruses and experience with vaccine development to the task.”

iBio created its proprietary VLP candidates in just a few weeks using its FastPharming System™. iBio’s researchers then deployed this plant-based expression platform’s rapid production capabilities to deliver VLPs suitable for further development just weeks after the biologics were designed. Dr. James Samuel, Head of the Department of Microbial Pathogenesis and Immunology at Texas A&M University, said:
Quote:
“We see strong potential for the IBIO-200 program given that we have both the glycosylated and non-glycosylated iBio VLPs as options for development. We look forward to completing the preclinical immunization studies for iBio to determine the optimal combination of VLP and adjuvant to advance to human clinical trials.”





Cash Rich
iBio Inc has a deal with Lincoln Park Capital Fund, LLC, for the purchase of up to $50M of its common stock over a three-year period subject to conditions. This will give the company plenty of cash to fund operations over the next three years. Cash is the biggest concern for small biotechs and that’s no longer a concern for iBio Inc.

Bottom Line
Coronavirus is here to stay until a vaccine is commercialized. iBio Inc is at the forefront of a vaccine and one of the best plays for investors on a pandemic the modern world has never seen before. If iBio Inc succeeds, it will solve a major humanitarian crisis and shareholders will have banked big profits. Good luck to all! - Source - https://insiderfinancial.com/ibio-inc-nysemktibio-new-highs-coming/179771/





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