Author Archives: Dan Stanton

Sartorius’ strong Q1 shows ‘defensiveness of bioprocess industry,’ analysts

Sartorius reported pronounced year-on-year increases in sales and orders for its first quarter 2020, indicating the opportunities for bioprocessing and the resilience of biopharma amid the coronavirus pandemic. For many businesses, the first quarter 2020 could be described as exceptional; at best subdued, but more realistically unsettling or even disastrous. Since January, the novel coronavirus (SARS-CoV-2) has led to systematic shutdowns and lockdowns, creating fiscal uncertainty and forcing many businesses to shut up shop. But for Sartorius Stedim Biotech, the…

MilliporeSigma invests $110m in gene therapy CMDO biz

MilliporeSigma is building a second facility at its gene therapy site in California, adding 11 production suites and more than doubling its viral vector capacity. The life sciences services division of Merck KGaA, MilliporeSigma, has been involved in the gene therapy area since 1997 through its site in Carlsbad, California. In 2016, the company expanded the site from 44,000 square feet to 65,000 square feet to meet growing demand for viral and gene therapy products. Now the firm has announced…

FairJourney and Iontas: Speed and collaboration key to developing coronavirus antibodies

Antibodies must be developable and manufacturable say FairJourney and Iontas, the latest partnership aiming to bring a therapy against COVID-19 to fruition. Recently we published a comprehensive guide to all the antibody-based therapies being developed to treat COVID-19, caused by the novel coronavirus (SARS-CoV-2). The latest firms looking to this modality in the battle against the virus are UK-based biotech Iontas and Portugese contract research organization (CRO) FairJourney Biologics, which announced a partnership to combine the latter’s phage display antibody…

COVID-19 pipeline: Industry flexing its Abs in fight against coronavirus

From Regeneron to GSK, monoclonal to bispecific, industry is increasingly looking at antibody (Ab) therapies to tackle the novel coronavirus. We bring you a comprehensive guide to what’s in the pipeline. Only six weeks ago, Bioprocess Insider brought to you a highlights reel of the treatments and prophylaxis in the development pipeline to treat COVID-19, caused by the novel coronavirus (SARS-CoV-2). But six weeks is a very long time in a global pandemic, and since then new projects have begun…

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…