Therapeutic Class

Spark brings cell culture suspension to hemophilia gene therapy

Spark therapeutics has strengthened its manufacturing capabilities to achieve scale of 2×200-liter suspension upstream and 400-liter downstream to support its hemophilia A gene therapy candidate. Spark Therapeutics – set to be acquired by Roche for $4.3 billion – made history in December 2017 when it won approval for the first the first gene therapy for a genetic disease in the US in the form of Luxturna (voretigene neparvovec). Luxturna is approved to treat patients with a rare form of inherited…

‘All us vendors competing in gene therapy space,’ says Repligen

Key wins in gene therapy applications helped deliver a record year for bioprocessing vendor Repligen. For the full year 2018, Massachusetts-headquartered bioprocess technology firm Repligen Corporation reported sales of $194 million (€171 million), up 37% on the year prior. And looking forward, CEO Tony Hunt said his firm is “well positioned to gain further market share, as the industry continues to pivot towards flexible solutions and continuous processing to manufacture the growing number of biological drugs including promising new entrance…

Fresenius awaiting success before investing further in biosimilars

Having acquired a portfolio of biosimilar candidates in 2017, Fresenius Kabi says it needs “to earn the right to spend” further in the space through commercial sales. Fresenius Kabi entered the biosimilar space in 2017 through the €656 million ($645 million) acquisition of Merck KGaA’s pipeline and Swiss-based R&D staff. The total number of molecules in development have not been divulged, but Fresenius has said it is in the high single-digits and includes versions of AbbVie’s Humira (adalimumab), Amgen’s Neulasta…

Orgenesis brings CDMO MasTherCell to US with Texas plant

Orgenesis has begun building a 30,000 square-foot cell and gene therapy manufacturing plant in Houston to be run by its CDMO subsidiary MasTherCell. Late last year, cell therapy contract development and manufacturing organization (CDMO) MasTherCell essentially doubled its capacity through the opening of a 6,500 square foot wing at its site in Gosselies, Belgium. Now the firm is looking to bring its services to the US through the construction of a 30,000 square foot manufacturing facility in Houston, Texas. According…

Roche to buy gene therapy firm Spark for $4.3bn

The acquisition of Spark Therapeutics will add commercial product Luxturna to Roche’s portfolio, along with a pipeline of gene therapies. Swiss pharma firm Roche has announced today it is set to buy Spark Therapeutics for approximately $4.3 billion (€3.8 billion). “The merger agreement has been unanimously approved by the boards of Spark Therapeutics and Roche,” Roche spokesperson Simone Oeschger told BioProcess Insider. “Under the terms of the merger agreement, Roche will promptly commence a tender offer, to acquire all outstanding…

Allogene building Cali allogeneic CAR-T facility

Allogene has confirmed it is building a 118,000 square foot cell therapy manufacturing facility in Newark, California to support its AlloCAR T candidates. Last month, Allogene Therapeutics revealed to BioProcess Insider its intentions to establish a manufacturing facility in the San Francisco Bay area. The firm did not provide projections at the time, but has now said it has entered a lease agreement at a site in Newark, California to build a 118,000 square foot cell therapy manufacturing facility. “This…

Merck accessing cancer vaccine tech through $300m acquisition

Merck & Co. will acquire Immune Design for $300 million, adding cancer immunization and adjuvant systems technologies to its portfolio. The deal, expected to close early in the second quarter of 2019, sees Merck & Co. (known as MSD outside of North America) acquire late-stage Californian immunotherapy firm Immune Design for $5.85 (€5.15) per share in cash, totaling around $300 million. “Our primary interest to acquire Immune Design is related to their unique portfolio of approaches to cancer immunization and…

Big data-science for cell therapies: Mogrify boosted by $3.7m funding

All current cell therapies are failing on at least one of three key performance indicators: efficacy, safety and scalability, says Mogrify’s new CEO Darrin Disley. Cambridge, UK-based firm Mogrify is looking to transform the cell therapy space through its technology platform that it claims makes it possible to transform – or ‘transmogrify’ – any mature human cell type into any other without going through a pluripotent stem cell or progenitor cell state. The firm has bolstered its position by raising…

AveXis on gene therapies: ‘We’ll get better at this and it will get cheaper’

AveXis has spent about $1 billion in preparing to launch its spinal muscular atrophy (SMA) gene therapy later this year. The Novartis subsidiary is pumping a further $60 million into its North Carolina facility. In May 2018, Gene therapy firm AveXis announced a $55 million (€49 million) investment to establish a manufacturing center in Durham County, North Carolina. Nine months on, and AveXis is doubling down on the site, revealing plans to invest a further $60 million and create 200…

Immunomedics: Data integrity and quality issues cited in FDA 483

The US FDA found antibody-drug conjugate developer Immunomedics to have manipulated data during an inspection last year. In January 2019, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Immunomedics for its antibody-drug conjugate (ADC) candidate sacituzumab govitecan, being developed to treat breast cancer. The firm said at the time: “The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need…