Author Archives: Gareth Macdonald

Mustang licenses transduction enhancer for XSCID program

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Mustang Bio will use a newly licensed cell transduction enhancer to make MB-207, its candidate therapy for “bubble boy disease.†The US biotech licensed rights to Sirion Biotech’s Lentiboost technology last week, explaining it will apply the transduction enhancer its X-linked severe combined immunodeficiency development (XSCID) program. CEO Manuel Litchman said, “Transduction enhancers were added to the cell processing of the lentiviral gene therapy in 2019 and several advantages have been observed. He added the firm plans to file an…

October 13, 2020

Lilly hires Fujifilm Diosynth Biotechnologies to make COVID-19 mAbs

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Eli Lilly has added Fujifilm Diosynth Biotechnologies to the list of firms manufacturing its candidate COVID-19 antibody therapies. The contract – which is part of Lilly’s agreement with the Bill & Melinda Gates Foundation – will see Fujifilm Diosynth Biotechnologies make commercial supplies of the product at its facility in Hillerod, Denmark. Production is expected to start in April next year. The facility – which was acquired from Biogen last year – houses six 20,000 L bioreactors for the production…

October 12, 2020

Regeneron and Pfizer sued for ‘unauthorised’ reagent use

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Allele Bio says Regeneron and Pfizer’s use of a labelling reagent during COVID-19-related vaccine and therapeutics development infringed on its IP. The San Diego biotech made the claim in lawsuits filed lawsuits against Regeneron and Pfizer this week. It said “both complaints address the infringement of Allele’s patented mNeonGreen reagent.†mNeonGreen is a fluorescent protein used in biological assays. Like Green Fluorescent protein, when mNeonGreen binds a specific molecule it gives off a fluorescent signal that can be used to…

October 9, 2020

Competition for CMOs drove inhouse investment, says Regenxbio

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Regenxbio says increasing competition for capacity in the CMO space prompted the adoption of a hybrid gene therapy manufacturing strategy. Industry demand for contract manufacturing organizations (CMOs) with the technical skills required to manufacture gene therapies has increased in recent years. According to the Alliance for Regenerative Medicine, as of Q3 last year, 370 trials involving gene therapies were ongoing, which is an increase on the 351 underway in the equivalent period in 2018. Katie Masterson, director of manufacturing operations…

October 6, 2020

Fujifilm to use PNI tech to make nanoparticles for VLP’s COVID vaccine

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VLP Therapeutics has hired Fujifilm Corp to help it manufacture its COVID-19 vaccine candidate for clinical trials. Under the deal, financial terms of which were not disclosed, Fujifilm will produce the lipid nanoparticle that is used to deliver the mRNA-based vaccine. The firm will also be involved in process and formulation development. The aim is to support efforts to move the vaccine into clinical trials. Mizuki Itou, a spokesperson for Fujifilm Holdings – Fujifilm Corp’s parent company – told us…

October 6, 2020

Sartorius set to acquire BIA Separations for $423m

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Sartorius Stedim Biotech has announced plans to buy Slovenian purification tech firm BIA Separations for €360 million ($423 million). The deal will see Sartorius pay €240 million upfront and €120 million in shares. The firm will also pay tranches of earn-out payments over the next five years. The transaction is expected to complete before the end of the year. AjdovÅ¡Äina, Slovenia-headquartered BIA develops and manufactures products for purification and analysis of large biomolecules, including viruses, plasmids and mRNA. Sartorius CEO…

October 5, 2020

Arranta says GMP plant on track despite pandemic

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Microbiome contractor Arranta Bio says construction of its commercial scale manufacturing plant is on schedule despite the coronavirus pandemic. The contract development and manufacturing organization (CDMO) announced the mechanical completion of GMP suites at the facility in Watertown, Massachusetts this week. CEO Mark Bamforth thanked, “Our construction management partner, DC Beane and Associates Construction Company…and the numerous sub-contractors who have supported Arranta and worked through the pandemic in a safe and efficient manner to keep our commercial-ready manufacturing facility build-out…

October 1, 2020

Single-use tech “unstoppable†if suppliers can meet soaring demand, says GSK

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COVID-19 has further increased already soaring demand for single-use tech according to a GSK expert who says boosting supply is key. Most biopharmaceuticals are made in stainless steel systems. But the past decade has seen interest in using disposable single-use systems increase. Initially the focus was in clinical supply. However, as Weibing Ding, director of GSK Pharma in King of Prussia, Pennsylvania told BPI East virtual conference delegates, a growing number of companies are trialing single-use systems for commercial-scale production.…

September 28, 2020

Pfizer to make Vivet’s Wilson disease gene therapy for Phase I/II trial

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Pfizer will make a candidate gene therapy for the liver condition Wilson disease under an agreement with Vivet Therapeutics. The US pharmaceutical firm will make supplies of the candidate – known as VTX-801 – for a Phase I/II clinical trial due to start early next year. Wilson disease is characterized by the accumulation of copper in tissue. It is an inherited disorder caused by mutations in the gene encoding the ATP7B copper transporter. VTX-801 is an AAV liver tropic capsid…

September 24, 2020

Biopharma set for COVID-related single-use shortages, says survey

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Biopharma faces delays obtaining single-use systems according to a survey that suggests disruption caused by the COVID-19 pandemic and increasing demand will result in shortages. Single-use bioprocessing technologies now dominate the pre-commercial manufacturing space according to research by Bioplan Associates. The organization quizzed 130 executives at biopharma firms and contract development and manufacturing organizations (CDMOs) and 150 tech suppliers and found that demand for single-use systems (SUS) has continued to increase in recent years. According to Bioplan managing partner Eric…

September 21, 2020