Author Archives: Dan Stanton

Get your TOX off: Piramal looks to next generation of ADCs

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Non-cytotoxic payloads, immune-stimulating antibody conjugates, and peptide-delivery mechanisms all form part of the new drug-conjugate landscape, says Piramal Pharma Solutions. It has been over 20 years since the first antibody-drug conjugate (ADC) hit the market. However, the sector has only taken off over the past three years with six US FDA approvals tallying the total number of marketed ADCs to 11, the latest being ADC Therapeutics’ Zynlonta (loncastuximab tesirine). Download our ebook ‘ADCs – Evolving Links in the Biopharmaceutical Pipeline’…

June 7, 2021

Cytiva looks to mechanistic modeling in GoSilico deal

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Cytiva says the acquisition of scientific software maker GoSilico will boost its position of leadership in the chromatography and process development spaces. The deal, financials of which have not been divulged, sees vendor Cytiva acquire Germany’s GoSilico, adding a portfolio of scientific software based on mechanistic modeling for use in bioprocessing functions. “In the simplest of terms, mechanistic modeling uses software to model a process and predict how something is going to respond – think weather forecasting,†Olivier Loeillot, VP…

June 4, 2021

Resilience to support AavantiBio’s gene therapy programs long-term

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AavantiBio has hired Resilience to make its gene therapies candidates, including a therapy for the currently untreatable progressive disorder Friedreich’s Ataxia (FA). Under the contract – described as a strategic collaboration – Resilience will provide process development and manufacturing as well as including cell lines and viral banks for in pre-clinical studies and clinical trials. The contract development and manufacturing organization (CDMO) will also develop and optimize processes for AvantBio’s other candidate therapies, with all of the work scheduled to…

June 4, 2021

Avantor boosts single-use production with RIM buy

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Avantor has added a manufacturing plant in Changzhou, China through the acquisition of single-use bag and system producer RIM Bio. The acquisition – financials of which have not been divulged – brings Avantor a facility in China that produces single-use systems including 2D bags, 3D bags, tank liners, bag assemblies and multi-bag manifolds used in the manufacturing of biologics, vaccines, and advanced therapies. Avantor said the addition of its first Asian single-use facility will help boost its global capabilities and capacity…

June 2, 2021

Moderna further expands CDMO partnerships to support COVID vaccine

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A triumvirate of CDMO expansions will increase production of Moderna’s COVID-19 vaccine: Lonza will repurpose a suite at a Dutch facility to up drug substance, and Aldevron will increase plasmid DNA supply. Meanwhile, Thermo Fisher will provide fill/finish capacity from North Carolina, as will Samsung Biologics from korea. Last month, Moderna announced plans to increase both internal and third-party production of its mRNA COVID-19 vaccine, currently being rolled out under an FDA Emergency Use Authorization (EUA). This included making an…

June 2, 2021

Venair doubling single-use capacity as global demand rockets

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Biopharma tubing firm Venair has broken ground on a $6 million facility in Spain to support a jump in demand triggered by COVID-19. The 2,200m2 ‘Excellence Center’ Venair Group near Barcelona, Spain will be fully operational by Q4 2022 and will double the firm’s global capacity for single-use equipment and tubing used in bioprocessing functions. “This center will focus on: Extrusion of silicone and TPE tubing, manufacturing of single-use bags, assembling of single-use kits, [and an] innovation center for the…

May 28, 2021

Robotic CAR? Cytiva and Multiply team on cell therapy automation

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Cytiva has partnered with Multiply Labs to create a fully automated robotic system intended to support commercial-scale cell therapy manufacturing. “Cytiva and Multiply Labs want to develop a robotic system that will automate the manufacturing processes for cell therapies and drastically bring down the cost to do so,†Parker Donner, head of Business Development, Cell and Gene Therapy at Cytiva told BioProcess Insider. “While these therapies have proven to be very effective, the manufacturing workflow is overly reliant on manual…

May 27, 2021

Alvotech latest to challenge AbbVie on US Humira exclusivity

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AbbVie is confident that no biosimilar will challenge Humira sales in the US until 2023 despite a legal challenge from Alvotech seeking to end the monopoly. Humira (adalimumab) is the world’s top selling drug, pulling in $19.8 billion in revenues for AbbVie in 2020. Of this, $16.1 billion was from the US, a region currently protected from adalimumab competition due to AbbVie’s web of patents and legal agreements with numerous biosimilar makers. But while the likes of Amgen, Samsung Bioepis,…

May 26, 2021

Gamma adds transfection reagents for RNA and gene therapy delivery in Mirus deal

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Gamma Biosciences has acquired a controlling stake in lipid-polymer nanocomplex (LPNC) developer Mirus Bio, bolstering its cell line development, viral vector manufacturing, and cell engineering offerings. Investment firm KKR launched Gamma Biosciences last year to operate a portfolio of life sciences tools investments and acquisitions. The latest deal has seen Gamma take a controlling stake in Madison, Wisconsin-headquartered Mirus, a supplier of transfection reagents used to support gene therapy and messenger RNA vaccine production. Financial terms have not been divulged.…

May 25, 2021

eBook: ADCs — Evolving Links in the Biopharmaceutical Pipeline

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Antibody–drug conjugate (ADC) developers both old and new are talking about the next generation of drug candidates coming through their pipelines. In April 2021, Zynlonta (loncastuximab tesirine, from ADC Therapeutics) became the eleventh such product to receive approval from the US Food and Drug Administration (FDA). But with dozens of ADC candidates currently in clinical trials, those 11 products represent the tip of the ADC iceberg. In this eBook, Dan Stanton (founding editor of BioProcess Insider) explores ADC production history,…

May 24, 2021