Author Archives: Dan Stanton

Podcast: Biopharma’s evolving relationships with CDMOs

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M&A, new modalities, and COVID-19 have all changed the way drug sponsors work with their third-party manufacturers, according to delegates from Samsung Biologics, Catalent, and AGC Biologics. The BioProcess Insider Expression Platform (BIEP) podcast is back, with an in-depth look at the evolving relationships between biopharma and their contract development and manufacturing organization (CDMO) partners. Recorded live from EBD’s BIO Europe Spring event last month, BioProcess Insider discussed the changing dynamic and reliance drug sponsors have with their CDMOs with:…

May 4, 2022

Pfizer pledges to pull out of Russian manufacturing pacts

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Pfizer says it is ceasing all future investment to build manufacturing capacity in Russia due to Vladimir Putin’s war against Ukraine. Putin’s universally criticized invasion of Ukraine has sent shockwaves across the world, with the pharma industry just one of many affected. Clinical trials have been disrupted, and the deepening conflict has driven concerns surrounding supply chains. Big Pharma has had a mixed response regarding its presence in the area, but several companies have announced they have scaled back activities…

May 4, 2022

Repligen: Robust bioprocess market will offset reduced COVID demand

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Repligen has tweaked its guidance in the wake of diminishing COVID-related orders but remains positive going forward due to a “very strong order book†for its base business. For the first quarter 2022, Repligen Corporation reported record revenue of $206.4 million, 45% up on the same period last year. Despite this, the bioprocess vendor has reduced its full year guidance by 4% from $800-$830 million to $770-$800 million due to the fall in COVID-related demand, something expected to continue throughout…

May 3, 2022

Despite pandemic, Samsung Bio set to open ‘super plant’ early

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Samsung Biologics says its fourth plant will begin operations by October — six months ahead of schedule.  Samsung Biologics announced plans for its so called ‘P4 Super Plant’ in August 2020. This week, the Korean contract development and manufacturing organization (CDMO) told stakeholders the first phase of biomanufacturing operations will begin in the coming months. “Samsung Biologics’ Plant 4 construction is expected to be partially operational by October 2022 to support 6 X 10 kL production capacity,†the firm said in…

April 29, 2022

Novartis CGTs first quarter 2022: Zolgensma up, Kymriah down

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Novartis reports increased sales for gene therapy Zolgensma due to expanded global access, but the failure in the second-line DLBCL setting will affect Kymriah sales. For Swiss Pharma giant Novartis’ cell and gene therapy (CGT) division, first quarter 2022 results were mixed. On the positive side, Zolgensma (onasemnogene abeparvovec) pulled in $363 million during the quarter, up 18% year-on-year due to increased access outside of the US. Sales of the one-time spinal muscular atrophy (SMA) gene therapy — approved in the…

April 27, 2022

Formulation lap: Sanofi turns to McLaren for manufacturing efficiency

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Sanofi has teamed with Formula 1 racing team McLaren to optimise manufacturing efficiencies within its network. The multiyear deal will see Sanofi’s Industrial Affairs team benefit from McLaren Racing team’s digital and analytical expertise tto achieve excellence in manufacturing operations. “Analysis of losses, modelling and simulation of production line scheduling, and specifically product change-overs, will be key areas to maximise performance in Sanofi manufacturing sites,†McLaren said in a press release. Both Sanofi and McLaren Racing “operate in a truly…

April 27, 2022

Danaher and Sartorius: COVID just one variable affecting bioprocess growth

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Comments from J&J have led to questions surrounding the long-term revenues from COVID-19 vaccines. However, the sector is just one area driving bioprocess growth, both Danaher and Sartorius say. While the COVID-19 virus is still virulent in some areas, the rapid development, scale-up, and delivery of vaccines over the past two years has helped bring the world back to some sense of normality. The unprecedented roll-out has resulted in hundreds-of-billions of dollars ending up in the pockets of several vaccine…

April 25, 2022

Seagen building $400m WA manufacturing plant

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Seagen will spend between $350 and $400 million over the next three years to construct a greenfield biomanufacturing site in Everett, Washington. Antibody-drug conjugate (ADC) pioneer Seagen (previously Seattle Genetics) will imminently begin constructing a biologics facility in Everett, Washington, close to its existing site in Bothell. The 270,000 square-foot plant is expected to be operational in 2024 and will employ up to 200 workers to produce clinical and commercial products. “In cancer research and development, Seagen must continue to…

April 25, 2022

Akron Bio launches plasmid DNA plant in Florida

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Akron Bio says the facility in Sarasota will support the growing demand for gene therapies and vaccines. In March 2020, Akron Bio – a supplier of biomanufacturing media and consumables – acquired a 60,000 square-foot biomanufacturing plant from Cambryn Biologics for an undisclosed fee. At the time, the firm told us that “with only minor adaptations, this plant will allow us to rapidly scale our existing products such as cGMP cytokines and media, while also establishing new lines of business…

April 15, 2022

Advanced therapy CDMO roundup: Deals for WuXi, Resilience, Fujifilm

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Resilience will make gene therapies for Opus; WuXi Advanced Therapies will make CAR-Ts for Chimeric; and Fujifilm will make RNA oncology candidates for Chimeron. First up in our roundup of advanced therapy contract manufacturing deals this week is Opus Genetics, which has struck a deal with (National) Resilience to support its pipeline of adeno-associated viral (AAV) vector-based gene therapies for inherited retinal diseases. The contract development and manufacturing organization (CDMO) will provide process and analytical development, quality control testing, and…

April 14, 2022