Author Archives: Gareth Macdonald

Mesoblast planning capacity hike if GVHD candidate is effective against COVID-19

Mesoblast says extra capacity will be needed to scale-up production of its GVHD candidate Ryoncil for use against COVID-19. When Australia’s Mesoblast raised $90m last month it said most of the money would be used to scale up production of its graft versus host disease (GVHD) candidate Ryoncil (remestemcel-L). CEO Silviu Itescu expanded on this last week, telling analysts the funds would be used to increase production of remestemcel-L in light of the coronavirus pandemic. “The proceeds from this offering…

Immobilize growth factors to cut cell therapy COGS say researchers

Cell therapy manufacturing costs could be reduced dramatically using immobilized growth factors in culture according to research. Industry interest in cell therapies has increased significantly in recent years. According to a report by US industry group PhRMA, there are 362 cell and gene therapies in clinical development, up from 289 in 2018. The surge in cell therapies entering the clinic is the “result of years of pioneering research by America’s biopharmaceutical research companies,” according to PhRMA. It also reflects the…

Oxford Biomedica to make AstraZeneca’s coronavirus vaccine for trials

Oxford Biomedica will make trial supplies of AZD1222 – AstraZeneca’s SARS-CoV-2 candidate vaccine – under a deal agreed this week. The cell and gene therapy contractor will make the adenovirus vector-based vaccine at its recently established manufacturing facility – known as Oxbox – at the Oxford Science Park in Oxford, UK. The agreement – which is for one year – will see Oxford Biomedica supply AstraZeneca with multiple batches of vaccine, the majority of which are expected to be produced…

Merck exercises option to use Vaxxas vaccine delivery patch

Merck & Co. will use Vaxxas’ delivery patch technology in one of its vaccine candidate development programs. Brisbane, Australia based Vaxxas announced the agreement today, explaining the US drug firm exercised an option under a co-development accord signed in 2012. Vaxxas CEO David Hoey told us the technology – known as the High Density Microarray Patch (HD-MAP) platform – “uses an ultra-high density array of very short projections applied briefly to the skin to rapidly deliver vaccine to the abundant…

AZ aims to ship Oxford’s COVID vaccine from September using BARDA’s $1bn

AstraZeneca says $1 billion from the US Biomedical Advanced Research and Development Authority (BARDA) will fund production of Oxford University’s SARS-CoV-2 vaccine. The Anglo-Swedish drug firm said it would begin production of the vaccine candidate – previously known as ChAdOx1 nCoV-19 and now called AZD1222 – in the autumn. It added that the BARDA funding will also support a support a Phase III trial involving 30,000 participants and a pediatric study. AstraZeneca set the funding as part of an effort to…

Cytiva to help Takara gear up for COVID-19 vaccine production

Cytiva will help Japan’s Takara Bio prepare manufacturing processes for a DNA-based SARS-CoV-2 vaccine candidate. Cytiva announced the collaboration this week, explaining it will work with Takara and partners Osaka University and AnGes to develop production processes and technology for the vaccine. Stephane Perrey, general manager for Cytiva in Japan, Australia, and New Zealand, told us “Cytiva is providing process design consultation, prioritization of equipment manufacturing and prioritization of consumables manufacturing. “We worked closely with Takara Bio to help them…

Rapid Micro Biosystems to fund EU facility construction with $120m fundraising

US sterility testing tech firm Rapid Micro Biosystems will build a European plant and expand its business with $120 million raised this week. The Lowell, Massachusetts firm – which makes automated microbial detection systems – completed a $120 million financing round this week, attracting equity investment from The Ally Bridge Group, Endeavour Vision, and existing investors including Asahi Kasei. CEO Robert Spignesi told Bioprocess Insider the firm’s “growth plan includes establishing new manufacturing capacity, beyond our current US manufacturing facility…

Swiss biomanufacturing revived in 2019 says industry group

Swiss biomanufacturing had a “resurgence” in 2019 according to an industry group which cited plant investments by drug firms and CDMOs as growth drivers. The Swiss Biotech Association – which represents biopharmaceutical companies, biotech and the services sector – made the comments in a recently published report. It wrote that, “Switzerland’s manufacturing prowess has experienced a revival in 2019, following years of “exporting” manufacturing capabilities aboard.” The organization highlighted Biogen’s decision to invest CHF 1 billion ($1 billion) in a…

FDA demands more manufacturing info to review ide-cel, says Bluebird

The US FDA has rejected Bluebird Bio’s Biologics license application (BLA) for ide-cel and asked for more details of how the candidate blood cancer therapy is made. Bluebird announced receipt of a “refuse to file letter” (RTF) in an SEC filing on Wednesday. The firm said the US Food and Drug Administration (FDA) asked for supplemental information on validation and control processes used in lentiviral vector and drug product manufacturing processes for Idecabtagene vicleucel (ide-cel), an investigational chimeric antigen receptor…

Greenlight raises $17m for mRNA vaccine capacity hike citing COVID-19 target

GreenLight Biosciences says a manufacturing expansion will allow it to make billions of doses of its mRNA-based COVID-19 vaccine. The Boston biotech announced the expansion plan last week, explaining it will use $17 million raised in a recent funding round to build out its scalable mRNA production capability. GreenLight is developing several mRNA vaccine candidates against SARS-CoV2, the virus responsible for COVID-19 disease. The aim is to establish “a scaled process under current good manufacturing practices (cGMP), capable of supporting…