Facilities & Capacity

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

Galaxy Life Sciences buys plot on Reactory campus for biopharma plant

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Biopharma factory developer Galaxy Life Sciences has bought a plot at an emerging biomanufacturing hub in Worcester, Massachusetts. The deal will see Galaxy build a $50 million facility to support research, development and manufacture of biopharmaceuticals or pharmaceuticals according to the Worcester Business Development Corporation, the organization that runs the “Reactory†campus. Galaxy CEO Mike O’Brien told us “We are talking to several tenants already and expect to have a commitment from at least one in the next month or…

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

How BARDA locked up COVID-19 vaccine manufacturing capacity for Operation Warp Speed

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The government agency that develops medical countermeasures for the US stockpile says it had to move quickly to secure contract manufacturing plant capacity for COVID-19 vaccines before the private sector could “capture†it. There was no time to give other contract manufacturers a chance to bid for the work, which the Health and Human Services Department’s Biomedical Advanced Research and Development Authority, or BARDA, recently awarded in a pair of task orders totaling nearly $900 million. BARDA awarded a $628…

August 12, 2020

Iovance hires Avid to make IL-2 receptor antagonist cancer candidate

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Avid Bioservices will make IOV-3001, Iovance Therapeutics’ candidate interleukin-2 receptor agonist intended for the treatment of cancer. Avid will commence analytical activities, upstream and downstream process development, and pilot-scale non-GMP manufacturing for IOV-3001. The firm will also work with Aragen Biosciences, which is carrying out cell line development activities. The next stage will see Avid manufacture the drug at its Myford facility in Tustin, California. News of the contract comes just a month after Avid said it planned to increase…

August 11, 2020

VGXI buys site and starts designing gene therapy and DNA vaccine plant

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VGXI has started designing a gene therapy and DNA vaccine manufacturing facility in Conroe, Texas that it says will be operational in early 2022. The contract development and manufacturing organization (CDMO) announced the acquisition of a site at the Deison Technology Park last week, also revealing that it is working with engineering consultancy BE&K on the facility design. The firm said it expects to start work on the plant in Q3 and predicted that construction will be completed late next…

August 10, 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

Kriya opportunities: Biotech sets up RTP manufacturing facility

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Kriya Therapeutics has set up a facility in North Carolina to support the production of its pipeline of AAV-based gene therapies. The site at Research Triangle Park (RTP) will house a process development lab, quality control and analytical development capability, pilot production suite. In addition, the facility will also have a current good manufacturing practice (cGMP) standard production infrastructure for gene therapies. CEO Shankar Ramaswamy told Bioprocess Insider: “By establishing our own internal manufacturing facility, we can help ensure that we have…

August 9, 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

ABC news: Lonza to scale-up ophthalmic therapy for Kodiak

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CDMO Lonza will use its global network, including a dedicated facility in Switzerland, to produce Kodiak Sciences’ antibody biopolymer conjugate (ABC) KSI-301. KSI-301 is an anti-VEGF biopolymer conjugate being developed by Kodiak Sciences for various ophthalmic retinal diseases. The candidate is in Phase II/III studies for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and as the firm looks to commercialization it has inked a deal for manufacturing scale-up with Lonza. The contract development and manufacturing organization…

July 29, 2020