Author Archives: Gareth Macdonald

No official cases but North Korea looks to up coronavirus testing

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North Korea has asked for help to increase COVID-19 monitoring capacity and has received reagents needed for testing, according to the WHO. Officially no COVID-19 cases have been reported in North Korea (DPRK). However, only a few hundred people have been tested for SARS-CoV2, the virus that causes the disease, according to World Health Organization (WHO) representative to DPR Korea, Edwin Salvador. “The WHO has been receiving weekly updates from the [DPRK] Ministry of Health on COVID-19. As of 2…

April 14, 2020

Orgenesis signs muscle-derived stem cell pact with Revatis

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Orgenesis has added muscle-derived stem cells to its offering through a manufacturing joint venture with Revatis. The partnership will supply developers of autologous cell therapies with exosomes and other cellular products obtained from muscle-derived mesenchymal stem cells (mdMSCs). The firm told us “The objective is to spin-off Revatis technology developed in the vet field into the human field; the JV  is currently planned to be  called “REVACEL. “After technology transfer, REVACEL will conduct development of muscle derived MSCs first and then as sourcing of…

April 13, 2020

Establish gene therapy tech early says Daiichi as it inks Ultragenyx deal

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Daiichi Sankyo has licensed a commercial-scale gene therapy manufacturing technology from Ultragenyx Pharmaceutical in a $200m deal. The Japanese firm will use Ultragenyx’s HeLa producer cell line and HEK293 transfection system for adeno-associated virus (AAV) manufacture in its gene therapy development programs. Masayuki Yabuta, head of Daiichi’s biologics division, set the deal as part of a wider investment in the firm’s gene therapy business. “In order to provide these drugs to patients in the future, manufacturing technology must be established…

April 9, 2020

Takeda, CSL and others working on plasma-derived COVID-19 therapies

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Takeda says COVID-19 therapy accord will work on TAK-888 and other plasma-derived meds developed by its partners. The Japanese drug firm teamed up with CSL Behring, Biotest, BPL Group, LFB and Octapharma this week. The aim is to turn blood plasma from recovered patients into treatments for COVID-19. The initial focus will be TAK-888, an anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine. But a Takeda spokeswoman told us the idea is to work on all in-progress development efforts. “Companies collaborating as part…

April 8, 2020

In-house advanced therapy production paves way for smaller facilities, expert

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Cell and gene facilities will get smaller according to an expert, who says automation and the vogue for in-house manufacturing will drive the change. Traditional biopharmaceutical manufacturing has relied on processes or platforms that can be used to make a range of products. For example, CHO-based expression systems are used to make many of the best-selling therapeutic proteins. While the specific processes differ for each product, the technologies and methods are common. The platform approach has influenced facility design. Most…

April 7, 2020

Growing interest in stem cells for COVID-19 ailments, says Cynata

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Stem cell therapies can treat COVID -19 complications says Cynata Therapeutics, which is in talks with potential development partners. The Australian biotech announced it was in talks in a March R&D update, telling investors industry interest in using mesenchymal stem cells (MSCs) to treat patients with conditions caused by severe COVID-19 infection had increasing. CEO Ross Macdonald confirmed talks are ongoing but told us “We cannot disclose the names of any of the companies or other parties with which we…

April 6, 2020

Wuxi Biologics signs R&D license for fungal expression tech

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Wuxi Biologics is testing a gene expression system that Dyadic International claims is faster and more efficient than competing systems. Dyadic shared details of the non-exclusive research license on March 30, explaining the Chinese contract development and manufacturing organization (CDMO) will evaluate the C1 technology and cell lines in a cGMP environment. The deal was confirmed by Wuxi Biologics spokesman Kevin Huang, who told us “This is to initiate a test of their C1 strain for microbial protein expression.†He…

March 31, 2020

Later in-licensing deals impacting biopharma CDMOs, says expert

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Biopharma firms are in-licensing candidates later according to an industry expert, who says the trend is impacting the CDMO sector. In-licensing – the practice of paying for rights to develop and commercialize a product discovered by another company – is a widely used strategy in the biopharmaceutical industry. According to a recent report in Nature the top 10 drug licensing deals in the first three quarters of 2019 were worth $34 billion (€31 billion), an increase of 10% from the…

March 27, 2020

Rapid response vaccine capacity vital for pandemics, BIO-Europe

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Experts fighting COVID-19 say governments and industry must invest in vaccine plants that can be brought online during future pandemics. The call came during the online conference BIO-Europe Spring plenary session. Moderna CEO Stéphane Bancel – whose RNA vaccine entered Phase I trials weeks after the SAR-COv2 sequence was published – told delegates rapid scale-up is vital during a pandemic. “The piece we are missing is infrastructure – Moderna is using a development plant to make vaccine for trials and…

March 24, 2020

Danaher closes in on $21bn GE takeover after FTC approval

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Danaher says the GE Biopharma takeover will complete this month after US competition authorities grant conditional approval for the $21.4 billion deal. The condition imposed by the US Federal Trade Commission (FTC) is that Danaher sells some bioprocessing technologies and products. The Commission announced its decision on March 20, explaining the original deal would have unfairly reduced competition. The divested techs will include microcarrier beads, various chromatography columns and skids, single use tangential flow filtration systems, label-fee molecular characterization instruments…

March 23, 2020