Author Archives: Dan Stanton

Over-capacity concern drives Bellicum to sell Texas CAR-T plant for $15m

The University of Texas MD Anderson Cancer Center has acquired the 60,000 square-foot Houston facility and entered into an agreement to manufacture cellular therapies for Bellicum Pharmaceuticals. The $15 million (€13.8 million) sale, first announced in January, went through this week and sees MD Anderson Cancer Center take over operations at the Houston, Texas site less than a year after Bellicum completed the buildout of the manufacturing space. The sale took place following an evaluation of Bellicum’s manufacturing strategy as…

J&J’s COVID-19 vaccine: ‘Four production plants, one billion doses by end of 2021’

J&J says its Janssen Adeno vector and PER.C6 technologies provide the ability to rapidly develop and upscale production of its COVID-19 vaccine candidate Not unexpectedly, much of Johnson & Johnson’s Q1 2020 financial call was taken up with talk of coronavirus. “COVID-19 is one of the most severe global health challenges we have seen in our lifetimes, but at the same time, we have unprecedented science and technology available today to help us mount a false and effective response,” said…

Patient Access Tops the List of Advanced Therapy Milestones at Phacilitate 2020

In a highly anticipated presentation at the 2020 Phacilitate Leaders World event — part of Advanced Therapies Week, along with the World Stem Cell Summit in Miami, FL — Susan Nichols (chief executive officer for Falcon Therapeutics), highlighted 10 events from 2019 that drove conversation, investment, and innovation in regenerative medicine. Although clustered regularly interspaced short palindromic repeats (CRISPR), business consolidations, and production capacity powered the cell and gene therapy (CGT) space in 2019, a new proactive focus on patient…

The Technology of Tomorrow — Today

Sponsored by BioProcess International and its sister publication BioProcess Insider, the “Tech of Tomorrow Zone” at Phacilitate 2020 played host to a number of companies showcasing platforms and ideas that they believe can revolutionize cell and gene therapy (CGT) manufacturing. Some common themes arose in this diverse zone, highlighting technologies from stem-cell supply solutions to viral-vector filling. Participating companies are aware of the complexities involved in producing regenerative medicines, and each proposed solution was intended to reduce the burden on…

Vir and GSK add CDMO Samsung Bio to COVID-19 MAb program in $362m deal

Speed and mass production capacity are key when manufacturing potential COVID-19 treatments, says Samsung Biologics as it becomes the latest CDMO to support Vir’s SARS-CoV-2 monoclonal antibody programs. Vir Biotechnology has a technology that identifies antibodies in people who are protected from, or who have recovered, from infectious disease. The firm is using this platform to tackle the novel coronavirus, and has partnered with GlaxoSmithKline (GSK) to bring lead candidates VIR-7831 and VIR-7832 through the clinic. The company says both…

Novel R&D approaches and the need for flexibility make single-use key in tackling COVID-19

Manufacturers are unlikely to look to traditional stainless-steel systems when developing COVID-19 vaccines despite the very high doses potentially needed, says MilliporeSigma. The list of biopharma companies rapidly developing vaccines is growing in response to the novel coronavirus (COVID-19) pandemic. Moderna Therapeutics has a messenger RNA (mRNA) in Phase I trials, Inovio Pharmaceuticals’ DNA vaccine entered human trials last week, while others including Novavax, which is developing a vaccine based on its recombinant protein nanoparticle platform, are racing towards the…

Cytiva on board for University of Queensland COVID-19 vaccine project

Cytiva – formerly known as GE Healthcare Life Sciences – will develop a prototype affinity resin to support a COVID-19 vaccine candidate being developed by the University of Queensland A team from the University of Queensland (UQ), Australia is working on a fast-tracked vaccine for the novel coronavirus, COVID-19, using its molecular clamp’ technology. The platform tech, invented by UQ scientists and patented by UniQuest, aims to provide stability to the viral protein that is the primary target for our…

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…