Author Archives: Dan Stanton

AveXis â€flexible’ NC plant a step closer to fully internal gene therapy network

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AveXis has opened a gene therapy plant in Durham it says will be able to produce up to seven products simultaneously. President Dave Lennon talks timelines, capacity, and taking production inhouse. AveXis and its owner Novartis have invested a total of $115 million (€106 million) into a site in Durham, North Carolina to support the production of US Food and Drug Administration (FDA) approved product Zolgensma (onasemnogene abeparvovec) and its pipeline of gene therapy candidates. With the doors opening last…

February 24, 2020

Another WuXi Vaccines deal? No, just a repurposed press release

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Contrary to some reports, WuXi Biologics is not building a second facility for its recently formed vaccines joint venture but has merely secured the $3 billion contract announced last May. Nine months ago, WuXi Biologics and Shanghai-based Hile Bio-Technology formed WuXi Vaccines, a contract development and manufacturing organization (CDMO) to service a Letter of Intent (LOI) inked with an undisclosed multinational vaccine company. In November, plans were laid to build a $240 million (€222 million) three-story dedicated manufacturing facility in…

February 21, 2020

KKR pumps €50m into Univercells through Gamma funding platform

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Over a quarter of Gamma Bioscience’s $200 million funding for next-generation bioprocessing technologies will be used to support Univercells’ biomanufacturing tech platforms. In January, global investment firm KKR launched Gamma Bioscience, a portfolio of life sciences tools subsidiaries. The first company to fall under the umbrella was Astrea Bioseparations, a ligand discovery and adsorbent development services firm, previously known as Prometic Bioseparations, acquired by KKR for around $100 million (€93 million) in November 2019. Now KKR and co-investors have committed…

February 19, 2020

Audentes $109m NC expansion boon for Astellas gene therapy plans

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Astellas acquisition Audentes has laid plans to build a 135,000 square-foot gene therapy manufacturing plant in Sanford, North Carolina. The $109 million (€100 million) plant is expected to be operational in 2021 and will support Audentes’ gene therapy portfolio. The firm’s lead product is AT132, a Phase I/II clinical-stage experimental treatment for X-linked myotubular myopathy (XLMTM), though the firm is also developing gene therapies for Pompe disease and Duchenne Muscular Dystrophy (DMD). “Our investment in large-scale manufacturing has always been…

February 19, 2020

Charles River eyeing up HemaCare expansion and more CGT acquisitions

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Charles River Laboratories says it is “seriously pursuing” geographical expansion of its recently acquired HemaCare business as it assesses further opportunities in the cell and gene therapy space. In December last year, contract research organization (CRO) Charles River picked up HemaCare for $380 million, bolstering its cell therapy services portfolio. The firm predicted the acquisition would add at least $50 million to its 2020 consolidated revenue and expects revenue growth for the business to substantially increase over the next five…

February 13, 2020

MilliporeSigma looks to â€ReForm’ bioformulations with excipient collaboration

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MilliporeSigma has teamed with ReForm Biologics to develop and license excipients for use in biologic formulations. The agreement will see the life science business of Germany’s Merck KGaA – known as MilliporeSigma in North America – access proprietary excipients from ReForm Biologics. The bioprocess vendor will fund the development of these excipients for use in the formulation of biological drugs, as well as take charge of manufacturing and commercializing them. “The parties have agreed to keep the exact terms to…

February 12, 2020

Catalent’s $315m Masthercell buy: Frothy exuberance or the new CMO norm?

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Catalent has completed its $315 million takeover of cell therapy manufacturer Masthercell. But is this latest CMO acquisition a sign of frothy exuberance, or consolidation of the new normal? Dark Horse Consulting’s Anthony Davies thinks the latter. Last week, Catalent announced it had entered into an agreement to buy Orgenesis’ third-party cell and gene therapy business Masthercell for $315 million (€285 million). Yesterday the deal closed, bringing autologous and allogeneic cell therapy manufacturing and analytical services to Catalent’s capabilities. The…

February 12, 2020

Latest insulin injection sees Novo Nordisk pump $117m in Danish plant

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A plant in Kalundborg that makes “around half of the world’s insulin” will benefit from another upgrade and expansion, says Novo Nordisk. Novo Nordisk’s site in Kalundborg, about 100 km west of Danish capital Copenhagen, has been making insulin products for over 50 years. The firm has heavily invested in production at the site over the past few years, and this latest expansion announced Friday sees a further DKK 800 million ($117 million) in upgrading and expanding facilities there. “Part…

February 10, 2020

With capacity stretched, GSK says limited growth for Shingrix vaccine until 2024

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With demand for shingles vaccine Shingrix continuing to outstrip supply, GSK says there is limited opportunity for further growth until extra capacity comes online. Meanwhile, the firm is investing $564 million at its vaccine operations in Belgium For GlaxoSmithKline’s vaccine business, sales grew 21% year-on-year to ÂŁ7.2 billion ($9.3 billion). The firm attributed this primarily to the growth in sales of Shringrix, its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster). The vaccine has continually seen quarterly…

February 7, 2020

FDA approves Seqirus’ adjuvant cell-based flu vaccine Audenz

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Seqirus says it is confident of supply of its newly approved cell-base influenza A (H5N1) vaccine Audenz in the case of a pandemic. The US Food and Drug Administration (FDA) gave the thumbs up to Seqirus for its vaccine Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted), making it the first adjuvanted, cell-based influenza vaccine approved to protect against influenza A (H5N1) in the event of a pandemic. Seqirus, a subsidiary of CSL Limited, is not planning to market the product…

February 7, 2020