Author Archives: Dan Stanton

CDMO deals and investments from AGC, Avid, and Fujifilm

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New deals inked by AGC Biologics, Avid Bioservices, and Therapure, while Fujifilm breaks ground in Texas. Welcome to Friday’s CDMO round-up. AGC Biologics has been contracted by Japan’s Ono Pharmaceutical for the manufacture of clinical materials. Details are scant but the agreement marks the latest deal announced by the contract development and manufacturing organization (CDMO) in recent months. Since the coronavirus pandemic began, AGC has been named as one of the manufacturers of Novavax’s COVID-19 vaccine candidate NVX-CoV2373; recently said…

August 21, 2020

Charles River boosts cell therapy offering with $38m Cellero buy

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The addition of cellular product supplier Cellero will complement last year’s acquisition of HemaCare says Charles River Laboratories. In December 2019, contract research organization (CRO) Charles River Laboratories expanded its services into the cell therapy space through the $380 million acquisition of HemaCare. The deal brought Charles River human primary cells as well as a core offering of leukapheresis – the separation of white cells from blood samples. Fresh from the purchase, Charles River said it was eyeing up further…

August 19, 2020

Passage: ‘Dedicated gene therapy suite gives us supply chain control’

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Manufacturing of GM1 gene therapy candidate PBGM01 from a dedicated suite at CDMO Catalent will begin by the end of the of the year, says Passage Bio. In July 2019, Passage Bio announced it had contracted Paragon Bioservices – fresh from its $1.2 billion acquisition by Catalent – to build a dedicated suite at its Harmans, Maryland facility to produce its AAV-delivered gene therapies for its monogenic central nervous system diseases; specifically GM1 gangliosidosis. GM1 is a rare monogenic recessive…

August 18, 2020

Samsung Bio plans ‘P4 Super Plant’ on back of COVID, bulging orders and capacity constraints

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A fourth plant at its site in Incheon, South Korea will bring Samsung Biologics a total of 620,000 liters of biomanufacturing capacity – approximately 30% of the total global biologics CMO capacity The contract development and manufacturing organization (CDMO) announced plans for what it calls the “P4 Super Plant†this week, explaining it plans to break ground at the site in Songdo within a year. Samsung Biologics said the decision was prompted by increasing demand for “COVID-19 treatments as well…

August 17, 2020

Lonza adding capacity to service Servier and high microbial demand

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As it expands capacity in Switzerland, Lonza says demand for antibody fragments, scaffolds and bioconjugates services is driving microbial manufacturing. Contract development and manufacturing organization (CDMO) will add a sixth microbial manufacturing facility at its biopark in Visp, Switzerland, currently under construction. The 3,000 L scale microbial facility will be used to service an extended manufacturing agreement with Servier, producing the asparaginase-based active pharmaceutical ingredient (API) for its acute lymphoblastic leukemia (ALL) therapies. Speaking with Lonza directors Clemens Jakobi and…

August 10, 2020

Robust first half results as Repligen feels COVID-19 tailwinds

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A robust quarter included a ramp-up in COVID-19-related orders, something Repligen says will set the scene for increased revenues in the second half of 2020. “Our results for the second quarter and through the first half of 2020 have been stellar,†Repligen CEO Tony Hunt told stakeholders last week. “We delivered overall revenue growth of 25%, including organic growth of 19% in the second quarter.†This equates to $164 million for the first half, compared to $131 million over the…

August 7, 2020

Moderna on $1.3bn manufacturing scale-up of mRNA COVID vaccine

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Moderna is confident of attaining 500 million doses of its COVID-19 vaccine candidate after using proceeds from a stock offering to scale-up manufacturing at its site in Massachusetts and at CDMO Lonza. In May, Moderna Therapeutics raised $1.3 billion through the sale of shares. According to the prospectus, the funds were to be used for “raw materials, labor and capital equipment purchases related to the manufacturing of mRNA-1273,†Moderna’s messenger RNA vaccine candidate in late-stage trials for COVID-19. This money…

August 6, 2020

Staying single: Lilly looks to optimize antibody manufacturing for COVID-19

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Eli Lilly is testing several antibodies in its efforts against COVID-19 but says a monotherapy, if successful, would help optimize manufacturing. Eli Lilly has several potential therapies in the clinic attempting to take on COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus. But speaking during the firm’s second quarter financial call last week, chief scientific officer Dan Skovronsky said the two programs he is most excited about are virus neutralizing antibodies for the treatment and prevention of COVID-19 are…

August 5, 2020

Merck betting on ‘swish-and-swallow’ and single administration COVID vaccines

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A recombinant vesicular stomatitis virus-based COVID-19 vaccine may be active when administered orally, says Merck as it begins clinical manufacture from facilities in Pennsylvania. Merck & Co. (known as MSD outside North America) entered the battle against COVID-19 relatively late, inking a triumvirate of deals in May. Two of the programs focused on vaccine development, one of which – a collaboration with non-profit research organization IAVI – is expected to begin clinical studies in the next few months. The program,…

August 4, 2020

MolMed latest add-on for expansion hungry AGC Biologics

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AGC Biologics has acquired Molecular Medicine (MolMed), increasing its presence in the CDMO space and adding a pipeline of cell and gene therapy candidates. In March, contract development and manufacturing organization (CDMO) AGC Biologics launched a voluntary tender offer to acquire Italian cell and gene therapy developer and manufacturer MolMed for €240 million ($284 million). Today the deal has been completed, bulking out AGC’s biopharma offering. On the services side, AGC adds two GMP sites in Milan and Bresso, both…

August 3, 2020