Author Archives: Dan Stanton

AGC Biologics doubling Danish capacity in $192m expansion

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Construction of a 19,000m2 facility at its site in Copenhagen is the latest example of the CDMO’s growth strategy. In February 2017, Japan’s AGC Asahi Glass (AGC) acquired CMC Biologics, a contract development and manufacturing organization (CDMO) with facilities in Seattle, Washington, and Copenhagen, Denmark. Later that year, the firm rolled out an expansion at the Danish site adding five 2,000 L single-use bioreactors to be run in single unit operations or in unison. In 2018, the CDMO – now…

December 1, 2020

mRNA vaccine: Pfizer’s inhouse approach vs Moderna’s use of third parties

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Though not heavily reliant on external suppliers, Pfizer is taking a higher distribution risk than Moderna and CureVac due to making its mRNA vaccine inhouse, says research firm Third Bridge. Earlier this month, both Pfizer and Moderna reported Phase III trial data showing their respective messenger RNA (mRNA) vaccines were above 90% effective against COVID-19. Pfizer submitted an Emergency Use Authorization (EUA) application with the US Food and Drug Administration (FDA) earlier this month, and Moderna is doing so today.…

November 30, 2020

Mustang expands ‘bubble boy’ gene therapy footprint with European CDMO

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Mustang Bio has established a European manufacturing base for its lentiviral gene therapy candidate MB-107 through a deal with cell and gene therapy CDMO Minaris. Developed with St. Jude Children’s Research Hospital, MB-107 is Mustang Bio’s lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID), also known as bubble boy disease. The candidate, which received US FDA Orphan Drug Designation in September, is manufactured from a facility in Worcester, Massachusetts but the firm is now looking outside…

November 26, 2020

Roche licenses cell line-based AAV vector tech from CEVEC

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Roche will access an adeno-associated virus (AAV) vector manufacturing platform for its gene therapy portfolio in a deal CEVEC says validates its ELEVECTA technology. The deal, financials of which have not been disclosed, will see Swiss pharma giant Roche use CEVEC’s ELEVECTA Technology for AAV vector manufacturing across its gene therapy portfolio, including products being developed by its acquisition Spark therapeutics. ELEVECTA, launched in April this year, is a platform that allows for the large-scale production of AAV vectors from…

November 24, 2020

Pharming doubling downstream capacity for commercial HAE therapy

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Pharming Group will build a facility at its site in Oss, the Netherlands to increase downstream manufacturing capacity for Ruconest, a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with hereditary angioedema (HAE). Dutch pharma firm Pharming is building a new facility to expand downstream processing capacity at its site in Pivot Park, Oss. Once operational, the facility will carry out the purification, filtration and concentration of the starting material for lead product Ruconest…

November 24, 2020

Samsung Bio in $150m deal to make COVID antibodies for Lilly

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Korean CDMO Samsung Biologics will produce COVID-19 antibody therapies for Eli Lilly as it signs another multi-hundred-million-dollar contract with a Big Pharma firm. Eli Lilly originally approached contract development and manufacturing organization (CDMO) Samsung Biologics in May as it looked to secure capacity for its range of potential COVID-19 treatments. Samsung was able to manufacture and deliver an initial supply of Active Pharmaceutical Ingredients (API) within five months, and as such the CDMO has become a strategic partner for Eli…

November 23, 2020

Pfizer looks to freezer farms and thermal shippers to make COVID vaccine distribution ‘doable’

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Pfizer says it is prepped to overcome the logistical challenges of distributing its mRNA vaccine against COVID-19 as it submits an Emergency Use Authorization (EUA) to the US FDA. Today, Pfizer submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of BNT162b2, an mRNA vaccine candidate codeveloped with Germany’s BioNTech, against SARS-CoV-2. The news follows Phase III trial data showing the vaccine has an efficacy rate of 95% and marks a major milestone…

November 20, 2020

Celltrion commits $453m for third plant with 60,000 L capacity

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Celltrion is constructing a third manufacturing plant at its site in Songdo, Korea and has a fourth in the works as it aims to have 600,000 L of bioreactor capacity operational by 2030. Korean drugmaker Celltrion has four biosimilars on the market and a pipeline consisting of five other potential biosimilar products and two novel biotherapeutics. Currently the firm has 190,000 L of bioreactor capacity available to it across two biomanufacturing facilities at its site in Songdo, Incheon, but aims…

November 19, 2020

Lonza making 400m doses of COVID vaccine and can scale up further if Moderna asks

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With four manufacturing lines prepped to produce 400 million doses, Lonza has congratulated Moderna on positive interim results for its mRNA vaccine against COVID-19. Biopharma has appeared to gain the upper hand on its battle against COVID-19 in the past week. First Pfizer and BioNTech reported positive interim results – a 90% efficacy rate – in a Phase III study of its mRNA vaccine candidate, and days later Moderna topped this reporting that its mRNA vaccine was shown to be…

November 18, 2020

Seqirus injects $580m into Australian cell-based flu vaccine plant

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The site in Melbourne will be the first cell-based manufacturing facility in the southern hemisphere to produce flu vaccines, along with Seqirus’ adjuvant MF59 and Australian antivenoms. Seqirus has been making seasonal flu jabs since 2015 after parent company CSL Limited acquired Novartis’ global influenza vaccine business. The firm has increasingly moved away from egg-based vaccine production towards cell-based manufacturing and has scaled up its capacity to meet demand. The latest investment announced this week is a plan to spend…

November 17, 2020