Author Archives: Dan Stanton

Amgen begins building $550m North Carolina plant

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Amgen hopes the Holly Springs facility will be operational by 2025, broadening the firm’s stainless steel and single-use drug substance capacity. The planned $550 million investment was made in August 2021, but this week Amgen broke ground on the 350,000 square-foot facility. When operational – expected 2025 – the North Carolina site will provide Amgen with ‘FleXBatch’ manufacturing, a combination of single-use technologies and stainless steel-fed batch production capabilities taking place in one plant. “For over four decades, Amgen has…

March 9, 2022

The 4 degrees of automation in cell therapy manufacture

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With cell therapy firms looking beyond manual production methods, Cellares claims its ‘factory-in-a-box’ Cell Shuttle platform can offer the ultimate in walk-away automation on an industrial-scale. For years, industry has looked to automated processes to make cell therapies safely and at scale. Success has been variable, but developers continue investing in automated technologies to help make their complex therapies cost-effective. “A lot of people agree that automation is the way to go,†Fabian Gerlinghaus, co-founder and CEO of Cellares told…

March 8, 2022

Biovian to make AAVs for ANLBIO Alzheimer’s gene therapy candidate

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CDMO Biovian Oy says it has the capacity to support viral vector needs through trials and beyond for ANLBIO from its Turku, Finland facilities. The deal sees biotech ANLBIO contract Biovian to support upcoming trials of its Alzheimer’s disease gene therapy candidate ANL-101. Financials have not been disclosed, but the Finnish contract development and manufacturing organization (CDMO) will supply GMP Cell Bank manufacturing, process and analytical development, and validation of product-specific analytical methods from its site in Turku. “This is…

March 7, 2022

Emergent lowers CDMO guidance as J&J assesses COVID vaccine demand

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Emergent Biosolutions will bring forward maintenance work at its Bayview plant on the back of customer J&J evaluating its COVID-19 vaccine supply network. J&J’s so-called ‘Janssen’ vaccine became the third to be approved under the FDA’s Emergency Use Authorization (EUA) in February 2021, and while the firm had plans to produce one billion doses, the single-shot jab has played third fiddle in Europe and the US to Pfizer and Moderna’ mRNA vaccines. The firm recently told us it has millions…

March 3, 2022

Maravai LifeSciences: $11bn+ would deliver Sartorius a nucleic acid unit

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According to media reports, Sartorius is looking to buy Maravai LifeSciences. We look at how such an acquisition may bolster Sartorius’ biopharma arsenal through a robust nucleic acid business. A Reuters exclusive last week claimed Sartorius made an offer to buy fellow life science vendor Maravai for $42 per share, or roughly $11 billion. The offer was allegedly rebuffed, according to sources close to the matter. Maravai provides products and services to enable the development and manufacture of drug therapies,…

March 1, 2022

Biocon buying Viatris biosimilar biz in $3.3bn deal

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Indian drugmaker Biocon will add a portfolio of biosimilars – estimated to bring in $875 million in 2022 sales – through the planned acquisition. The deal, announced Sunday, will see Biocon Biologics pay up to $3.335 billion, made up of $2.335 billion in cash and $1 billion in Compulsorily Convertible Preference Shares (CCPS), for its partner Viatris’ biosimilars division. Viatris will own at least 12.9% of Biocon Biologics once the deal goes through. Kiran Mazumdar-Shaw, Biocon’s executive chair, described the…

February 28, 2022

eBook: Gene Therapies —
Developers Slowly Emerge from a Pandemic

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This eBook gauges shifting expectations for the gene therapy industry amid the COVID-related uncertainties and clinical setbacks of the past couple years. BioProcess Insider founding editor Dan Stanton reports on the January 2022 Phacilitate Advanced Therapies Week event, specifically a standing presentation on the 10 most important industry drivers from the past year. Since 2017, advancements in gene therapies have featured prominently in these presentations. In 2021, gene therapies again made the list, but this time for more troubling reasons,…

February 18, 2022

EUAs for rare disease advanced therapies? Not likely, says FDA

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The FDA has dismissed using special emergency authorization powers for rare disease advanced therapeutics but does hope to significantly speed up its feedback to sponsors. The US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) authority allows the use of unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threats when certain criteria are met. Most recently, EUA powers have…

February 17, 2022

Takeda contracts Resilience to bolster plasma network

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The deal sees CDMO Resilience support the development and manufacture of Takeda’s plasma-derived medicines portfolio from its site in Ontario, Canada. Reporting on its third quarter FY2022 at the beginning of this month, Takeda posted revenues of 363.2 billion yen ($3.2 billion) from its plasma-derived therapy (PDT) immunology division, up 10% year-on-year and driven by immunoglobulin and albumin sales. The firm also told stakeholders it is undergoing a strategy to increase plasma supply and manufacturing capacity by more than 65%…

February 17, 2022

UK reportedly selling £200m vaccine plant that never produced a single dose

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It is reported the UK government has turned its back on the Vaccine Manufacturing & Innovation Centre (VMIC), a facility setup in response to COVID-19 that never actually opened its doors. The UK Government’s Vaccine Taskforce launched several programs to tackle the COVID-19 pandemic as it emerged in early 2020, including one to address the country’s lack of vaccine manufacturing capacity. The VMIC in Harwell, about 50 miles west of London, planned to offer up to 70 million doses of…

February 14, 2022