Author Archives: Millie Nelson

Lonza experiences CGT headwinds but hails pipeline for bounce back

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Lonza says a slowdown in funding and clinical trial issues in 2022 led to slower cell and gene therapy (CGT) sales growth compared to 2021. Contract development manufacturing organization (CDMO) Lonza reported sales of 6.2 billion CHF ($6.7 billion) in Q4 2022, a 15.1% sales increase on 2021. Its biologics division sales grew by 21.7% compared to 2021 and the firm’s CGT business sales increased by 13.6%. Lonza’s chief financial officer (CFO) Philippe Deecke attributed the smaller sales growth of…

January 26, 2023

AGC builds on Provention partnership with diabetes mAb production

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AGC Biologics’ Bothwell, Washington site is commercially manufacturing Provention Bio’s type 1 diabetes (T1D) monoclonal antibody Tzield (teplizumab). Provention Bio said it selected AGC Bio to produce Tzield – the first authorized drug that can delay onset T1D –  after the contract development manufacturing organization (CDMO) supported the drug ahead of its approval by the US Food and Drug Administration (FDA) in November 2022. Tepilzumab is manufactured in two main stages: the upstream process followed by the downstream process,” Kevin…

January 26, 2023

Biomanufacturing Lotte! CDMO to invest $3bn in Korea

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Lotte will invest $3 billion over the next seven years to construct three ‘mega’ plants in Korea with a production capacity of 360,000 L. Contract development manufacturing organization (CDMO) Lotte Biologics said each plant will have the ability to produce 120,000 L of antibody drugs. Furthermore, the plants will have additional expansion plans to include a small-scale incubator for clinical drug substance manufacture and a commercial drug product production facility. The build-out of its first plant will start in the…

January 24, 2023

Normax and MTIF take mRNA tech to UK Uni

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Normax Biomed has partnered with Medical Technologies Innovation Facility (MTIF) at Nottingham Trent University (NTU) to provide access to Telesis Bio’s BioXP system. The agreement, of which financial details have not been divulged, will see NTU develop and discover gene therapies and messenger RNA (mRNA) vaccines using the BioXP system. Irish mRNA-based company Normax claims the BioXP platform, created by Californian firm Telesis Bio, is the world’s first commercially available end-to-end fully automated bench top synthetic biology system . The…

January 23, 2023

FDA rejects early approval for Lilly’s Alzheimer’s drug

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The US FDA has declined to grant Eli Lilly accelerated approval of monoclonal antibody drug, donanemab. Eli Lilly said the complete response letter (CRL) received from the US Food and Drug Administration (FDA) has been issued due to the limited number of patients with at least one year of drug exposure data provided in the application and stated that no other deficiencies have been identified. The FDA specifically requested that Lilly provide data from a minimum of 100 patients who…

January 20, 2023

Pfizer to acquire Abzena’s NC manufacturing plant

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Pfizer is set to acquire a drug substance facility in Sanford, North Carolina from Abzena to expand capacity and support its CentreOne clients. British contract development manufacturing organization (CDMO) Abzena announced the addition of a sixth global site in the US in January 2021. Three months later, the firm revealed it had selected Sanford, North Carolina as the site of a biologics manufacturing facility, which would cost the firm over $200 million and be equipped with 12x 2,000 L bioreactors.…

January 19, 2023

Catalent and Avantor ink multi-year supply and services deal

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Avantor will supply Catalent with clinical and production materials, services, and laboratory supplies. Avantor, a company that provides products and services to clients in the life sciences space, has entered into a multi-year supply and services agreement with contract development manufacturing organization (CDMO) Catalent. No financial details of the deal are being disclosed but the partnership will see Catalent work with Avantor across more than 50 facilities situated across the globe. “Avantor is an existing supplier to Catalent,” a spokesperson…

January 18, 2023

Resilience steps out of North America to build UAE facility

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Resilience has signed a deal with its investor Mubadala Investment Company PJSC to establish a secure supply chain and will construct a facility in Abu Dhabi, UAE. Under the terms of the deal, Abu Dhabi sovereign investment firm Mubadala will be responsible for the build-out of the manufacturing facility. However, the plant will be operated by National Resilience to produce specific biopharmaceutical-related products in the United Arab Emirates (UAE). “As many other governments across the globe, Mubadala has recognized the…

January 17, 2023

Hospira experience will aid Abzena success, says new CEO

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The experience of leading the operational turnaround at Hospira provides a robust framework for advancing Abzena’s success, says newly appointed CEO Matthew Stober. Contract development manufacturing organization (CDMO) Abzena, which focuses on antibody drug conjugates (ADCs) and biologic molecules, announced this month that Stober would replace Jonathon Goldman as CEO. Most recently, Stober held position of CEO at CastleVax and Istari Oncology. However, while all of his past job roles are undoubtedly influential, his experience of leading the turnaround of…

January 16, 2023

Argonaut to expand fill/finish capabilities in California

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CMO Argonaut Manufacturing Services will use capital investment led by Telegraph Hill Partners to expand its manufacturing capabilities in Carlsbad, California. Contract manufacturing organization (CMO) Argonaut serves the life sciences, biopharma, and molecular diagnostics space. While specific financial details have not been disclosed, the firm said the investment will be focused on expanding its Carlsbad manufacturing facilities by installing a fill/finish line. According to Argonaut, the addition of a fill/finish line will expand the CMO’s footprint on the west coast…

January 16, 2023