Author Archives: Dan Stanton

Bayer elusive on $2.2bn manufacturing revamp plan

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Bayer says a three-year production reorganization will modernize its manufacturing network and streamline its supply chain, but specific details remain scarce. The Germany-headquartered biopharma firm announced “it is strengthening the production network of its pharmaceutical division†yesterday through a three-year, €2 billion ($2.2 billion) restructure plan. According to the release, “Bayer is planning to invest in its core manufacturing plants and strengthen their operational responsibilities to sustainably support the implementation of the company’s strategy for its pharmaceuticals business. A significant…

April 1, 2022

Vetter and Rentschler double down on CDMO collaboration

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Having originally teamed up in 2020, the two CDMOs have rebranded their combined drug substance and fill/finish service offering under the ‘Xpert Alliance’ umbrella. The German contract development and manufacturing organizations (CDMOs) formed a strategic alliance in July 2020 to offer customers Rentschler’s drug substance manufacturing capacity in combination with Vetter’s aseptic fill and finish and secondary packaging services. Nearly two years on, and the partnership has been formalized further through the creation of the ‘Xpert Alliance’ brand; a “visualization…

March 31, 2022

Latent application: Moderna lauds mRNA manufacturing for herpes, HIV and beyond

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Moderna says the flexibility and footprint of mRNA production can overcome scaling-up issues seen with current latent virus vaccines like GSK’s Shingrix. Moderna entered the ‘Big Pharma’ space in 2021 when its COVID-19 vaccine Spikevax became the second messenger RNA (mRNA) product to achieve commercial success. Last year, 807 million doses of the vaccine were sold, bringing in $17.7 billion for Moderna. For comparison, Moderna reported total sales in 2020 of $803 million and $60 million in 2019. Going forward,…

March 28, 2022

Gilead closing Immunomedics plant in NJ operations overhaul

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Manufacturing of cancer drug Trodelvy will be moved to Oceanside, California as part of a restructuring of Gilead Science’s New Jersey operations. In September 2020, Gilead paid $21 billion to acquire Immunomedics. The deal added antibody-drug conjugate (ADC) Trodelvy (sacitizumab govitecan) – approved in April 2020 to treat triple negative breast cancer – to Gilead’s portfolio, along with an biomanufacturing facility in Morris Plains, New Jersey. But plans to create a corporate hub in Northern New Jersey will result in…

March 25, 2022

Rolontis review: Spectrum confident manufacturing deficiencies resolved

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Spectrum Pharmaceuticals has resubmitted the BLA for eflapegrastim following the remediation of manufacturing deficiencies at a drug substance facility in Korea. In August 2021, Spectrum received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its long-acting granulocyte-colony stimulating factor (G-CSF) agent Rolontis (eflapegrastim). The letter, which put a hold on Spectrum’s Biologics License Application (BLA) for eflapegrastim, identified manufacturing challenges. But during his firm’s fourth quarter 2021 financial call last week, CEO Tom Riga…

March 23, 2022

Manufacturing must align with new modalities to drive efficiency, AltruBio

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Innovation has realized the potential of advanced therapies, but bioprocess and manufacturing tech advancements are now needed to feed future demand, says AltruBio’s Judy Chou.  While the COVID-19 pandemic kept industry physically apart – making the meet in San Diego this week the first BPI West since 2019 – it brought the biotech space together, resulting in the rapid approval and rollout of the first two mRNA vaccines. Concurrently, the past few years have seen numerous cell and gene therapy successes,…

March 17, 2022

Sanofi refills ADC pipeline with Seagen pact

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The deal will see Sanofi and Seagen collaborate on antibody-drug conjugate (ADC) candidates targeting up to three cancer targets.  Sanofi will leverage its monoclonal antibody (mAb) technology with Seagen’s ADC platform in the partnership. Specific financials are scarce, but Sanofi will make an undisclosed payment to Seagen for each of the three targets as they are selected. The development costs and future profits will be shared between the two companies.  “This collaboration will enable the synergistic combination of molecules and platforms to produce candidate medicines with the potential of bringing renewed hope to cancer patients…

March 16, 2022

J&J taking ‘disciplined’ approach to CAR-T rollout

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“CAR-T cell manufacturing is not a finished product,†says J&J EVP Mathai Mammen as he speaks about his firm’s rollout of recently approved myeloma therapy Carvykti. Last month, Johnson & Johnson received the regulatory thumbs up for its chimeric antigen receptor T-cell (CAR-T) therapy Carvykti ( ciltacabtagene autoleucel; ciltacel), developed with China-focused partner Legend Biotech. The therapy is the second BCMA CAR-T approval – Bristol-Myer Squibb’s Abecma (ide-cel) received FDA approval in March 2021 – and the first cell therapy success…

March 16, 2022

Novartis playing in cell therapy CDMO space with Carisma

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Novartis will make a macrophage-based cell therapy targeting breast cancer for Carisma Therapeutics from its Morris Plain, New Jersey site. An initial agreement signed this week will see Novartis manufacture a HER 2 targeted CAR-Macrophage (CAR-M) cell therapy for Carisma from the beginning of 2023. The candidate, CT-0508, is the first CAR-Macrophage cell therapy to enter clinical trials. Preclinical trials have shown the potential to overcome key challenges faced by other cell therapies treating solid tumors, including: The capacity to…

March 14, 2022

Sanofi’s $1bn French booster part of 5-year mRNA plan

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The announced investment is not news, but rather an opportunity for Sanofi to drive France’s mRNA ambition as it lays the foundation stone at a production site in Lyon. Sanofi issued a press release (in French) this week announcing plans to invest €935 million ($1 billion) between 2022 and 2026 “in order to provide France with a complete and autonomous value chain in mRNA technology.†The announcement was made during the groundbreaking ceremony for Sanofi’s Evolutive Vaccines Facility (EVF) in…

March 11, 2022