Author Archives: Dan Stanton

Inovio’s COVID-19 vaccine enters clinic buoyed by VGXI manufacturing success

Inovio Pharmaceuticals has asked VGXI to scale-up manufacturing of a potential DNA vaccine against COVID-19 after an initial production run provided materials for a Phase I trial that began this week. The first dosing of INO-4800, a DNA vaccine candidate designed to prevent COVID-19, took place this week after the US Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application. The Phase I study of INO-4800 will enroll up to 40 healthy adult volunteers at the…

BAT biotech using tobacco to make COVID-19 vaccine candidate

British American Tobacco (BAT) will use its tobacco-based expression technology to make a not-for-profit vaccine candidate targeting the novel coronavirus. The vaccine candidate has been developed by Kentucky BioProcessing (KBP), the wholly owned subsidiary of the Big Tobacco firm BAT. “KBP recently cloned a portion of the genetic sequence encoding the selected coronavirus antigen – a substance which induces an immune response in the body and the production of antibodies,” a BAT spokesperson told this publication. “This sequence was then…

Allogene turns to MaxCyte’s tech for its off-the-shelf CAR-T therapies

MaxCyte says its clinically validated electroporation technology will help increase efficiency and improve yield of Allogene’s allogeneic CAR-T therapy candidates. Pfizer-backed biotech Allogene launched in 2018 with a focus on developing allogeneic, or off-the-shelf, chimeric antigen receptor (CAR) T-cell therapies. To achieve this, the firm has regularly stressed the importance of manufacturing, devoting “considerable time and resources” to the process. Now the firm has inked a deal to use MaxCyte’s ExPERT platform to develop and advance its candidates through to…

Akron buys Cambryn plant on back of high CGT demand

The addition of a biomanufacturing plant in Florida will support the high demand for Akron Biotech’s cytokine and media products from the blossoming cell and gene therapy sector. Akron Biotech has expanded its operations by acquiring a biologics facility in Sarasota, Florida second manufacturing plant. The firm makes cGMP-compliant cytokines that are embedded in numerous clinical and commercial cell therapies and the addition of a second facility is needed to expand capacity to meet the tremendous demand, according to Akron…

J&J to expand vaccine capacity as part of $1bn BARDA coronavirus collaboration

Johnson & Johnson (J&J) says it will leverage and expand facilities in The Netherlands and Pennsylvania in efforts to reach one billion doses of a potential COVID-19 vaccine. In February, J&J teamed up with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS) to develop a vaccine against the novel coronavirus (COVID-19). At the time the company said it would work to upscale production and manufacturing capacities, leveraging its AdVac and PER.C6…

Cytiva rises out of GE Healthcare as Danaher completes $21bn deal

It’s “absolutely business as usual” says Cytiva, the bioprocess vendor formerly known as GE Healthcare Life Sciences, despite a new owner and an ongoing coronavirus pandemic.   Three months later than originally planned, Danaher Corporation has completed the largest ever acquisition in the bioprocess space, adding the biopharma business unit of GE Healthcare to its life sciences portfolio. The $21.4 billion (€19.4 billion) deal brings Danaher a range of products including the AKTA, Hyclone, MabSelect, Wave, and Xcellerex brands, along…

Translate Bio, Sanofi secure CDMO capacity for potential COVID-19 mRNA vaccine

Sanofi has become the latest firm to leverage mRNA vaccine technology to tackle COVID-19. Its partner Translate Bio, meanwhile, has secured dedicated manufacturing capacity at AMRI to respond to the potential global demand. France’s Sanofi Pasteur announced it is extending an alliance formed in 2018 with Translate Bio specifically to target the novel coronavirus (COVID-19). Translate is already producing multiple mRNA constructs through its MRT platform, and now the platform will be used to discover, design and manufacture a number…

Lonza media launch to support Sf9 insect cells for gene therapy production

Insect-based expression systems remain effective in making gene therapies says Lonza as it launches a medium specifically to produce Adeno Associated Virus (AAV) in Spodoptera Frugiperda (Sf9) cells. According to Lonza, the TheraPEAK SfAAV Medium is the first chemically defined, non-animal origin medium designed specifically for the production of AAV in Sf9 insect cells for gene therapy applications. “This medium is chemically defined and we have compared its performance with four other media on the market currently. It allows for…

Sensationalist press propagating unfounded COVID-19 therapies, says ISCT

Industry consortium the International Society for Cell & Gene Therapy (ISCT) has warned of the dangers of unproven therapies as unscrupulous players look to take advantage of COVID-19 uncertainties. The 1918 Spanish flu outbreak saw the advocation of a host of unproven remedies by the media and advertising firms. These included tobacco, heroin, cocaine, laxatives, malted milk, and literal snake oil. Over a hundred years on with the world caught up in another pandemic, quack remedies and snake oil are…

Vaccine production plant forms part of Canada’s COVID-19 response

The University of Saskatchewan’s (USask) has received funding from the Canadian government to construct a pilot manufacturing plant to support trials of a COVID-19 vaccine candidate. Like many governments, Canada’s is ploughing funds into tackling the coronavirus pandemic currently sweeping the globe. A CAD 275 million ($195 million) fund for COVID-19 health research has been announced, and includes several investment in USask’s Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac), which it says is one of the largest and most…