Author Archives: Dan Stanton

From baking to bioprocessing: Lumen leases Seattle plant to advance ‘edible’ antibodies

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Spirulina-based antibody developer Lumen Biosciences will convert a bakehouse into a biologics plant capable of producing 15 kg per week of cGMP-grade drug substance. Seattle, Washington-based Lumen turns spirulina – protein-rich cyanobacteria touted by many health enthusiasts as a ‘superfood’ – into tiny factories that churn out therapeutic antibodies. To support the development of its candidates, the firm has expanded its manufacturing footprint by leasing a former bakery in the Fremont-Wallingford neighborhood of Seattle. “All of our current products are…

July 26, 2021

Second Bluebird gene therapy approval a boon for Minaris

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CDMO Minaris says it will be the commercial manufacturer for Skysona (elivaldogene autotemcel, Lenti-D), a second Bluebird Bio gene therapy approved by the European Commission. The European Commission (EC) granted marketing authorization of Skysona for the treatment of early cerebral adrenoleukodystrophy (CALD) yesterday. The one-time gene therapy uses a patient’s own hematopoietic stem cells (HSC) to treat the underlying cause of the neurologic condition CALD. SKYSONA uses ex vivo transduction with the Lenti-D lentiviral vector (LVV) to add functional copies…

July 22, 2021

Humira: AbbVie’s biosimilar erosion woes may be overstated

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An analyst says general forecasts of biosimilar erosion for Humira (adalimumab) are too pessimistic as the size of the brand could still present upsides for AbbVie. AbbVie’s monoclonal antibody Humira continues to be the world’s top selling drug, despite biosimilar competition hitting sales outside of the US over the past few years. In 2020, global sales stood at $19.8 billion, $16.1 billion of which came from the US. As it stands, legal agreements between AbbVie and a host of biosimilar…

July 16, 2021

Forge Bio wins GentiBio AAV vector contract

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Forge Bio will develop and manufacture adeno-associated viral (AAV) vectors for GentiBio’s engineered Tregs candidates from its site in Columbus, Ohio. The deal will see contract development and manufacturing organization (CDMO) Forge Bio use its Blaze Vector production platform and HEK 293 Suspension Ignition Cells to support GentiBio’s preclinical and clinical programs. The work will be undertaken at Forge Bio’s facilities at The Hearth, Columbus, which has grown through heavy investment over the past year. “Forge has rapidly expanded our…

July 16, 2021

Rebranded AMRI on spending spree with LakePharma and Integrity buys

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A new name, the purchase of biomanufacturer LakePharma, and the addition of fill-finish firm Integrity Bio. All in a week’s work for Curia, the CDMO previously known as AMRI. Contract development and manufacturing organization (CDMO) AMRI rebranded itself this week as Curia before announcing a double acquisition expected to boost its capacity and capabilities in the manufacturing services space. The first deal sees the CDMO acquire Integrity Bio, a privately held formulation and fill-finish organization headquartered in Camarillo, California. Financials…

July 15, 2021

Poseida joins Cellares’ early-access cell therapy tech program

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Cellares Corporation has added a third firm to its early-stage partnership program, giving Poseida Therapeutics access to its closed and automated cell therapy manufacturing platform. Californian firm Cellares is looking to overcome limitations in current advanced therapy manufacturing through the development of its manufacturing platform, the Cell Shuttle. The Cell Shuttle is a modular and automated solution comprising hardware, software, robotics and consumables and according to the firm is capable of producing 10 patient doses simultaneously. Since 2020, the firm…

July 14, 2021

Chinese CDMOs eye advanced therapies and global markets

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Univercells Technologies says traditional small molecule Chinese CDMOs are rapidly expanding into the cell and gene therapy space as it partners with viral vector producer VectorBuilder. The partnership will see Univercells Technologies – a bioprocess technology firm under KKR’s Gamma Biosciences umbrella – work with VectorBuilder’s manufacturing center in Guangzhou, China to develop and optimize platform processes for the production of custom viral vectors for both cell and gene therapies and vaccine applications. “Through this partnership, both parties will leverage…

July 12, 2021

Thermo Fisher opens Korean bioprocess center

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The Bioprocess Design Center (BDC) in Incheon, Korea will offer support to the region’s continually growing biomanufacturing industry, says Thermo Fisher. The Songdo, Incheon BDC opened its doors earlier this month with the aim “to help enhance the competitiveness of the Korean bio industry,†Scott Song, director of BioProduction and Laboratory Chemical at Thermo Fisher Scientific, said during a promotional video announcing the opening of the site. “The BDC will play a pivotal role in realizing Thermo Fisher Scientific’s vision…

July 9, 2021

FDA slams unapproved flu vaccine seller Davati Medical

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Offering the sale of unapproved influenza vaccine Fluzalp Quadrivalent has landed Davati Medical Supply with a US FDA warning letter. Fluzalp Quadrivalent is an intramuscular vaccine manufactured by Indian firm Anzalp Pharmasolutions. While Anzalp’s motto is ‘Healthcare with Ethics,’ the same cannot be said for US distributor Davati Medical, which received a US Food and Drug Administration (FDA) warning letter last month for offering the vaccine to US consumers, despite it not being approved in the region. The company claims…

July 9, 2021

FDA quality concerns land Provention diabetes mAb with a CRL

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Provention Bio says the US FDA’s Chemistry, Manufacturing and Controls (CMC) concerns relating to its type 1 diabetes candidate teplizumab are addressable in the short-term. Provention Bio has hit a snag in its Biologics License Application (BLA) for teplizumab (PRV-031), its investigational anti-CD3 monoclonal antibody (mAb) being developed for the delay of clinical type 1 diabetes. On July 2, the firm received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) citing concerns relating to pharmacokinetic/pharmacodynamic…

July 9, 2021