Therapeutic Class

FDA commissioner resignation ‘a great day for rogue stem cell clinics’

Scott Gottlieb will step down from his position as commissioner of the US FDA next month. He issued more cell and gene therapy guidance in his two-year tenure than had appeared in the previous ten. In May 2017, the US Senate confirmed Dr Scott Gottlieb as commissioner of the US Food and Drug Administration (FDA). This week, nearly two years on, and Gottlieb announced he is to step down from the role in the next month. Among Gottlieb’s achievements are…

Autolus: ‘Fully-enclosed and machine-made’ CAR-Ts to lower COGS

Having begun to build out its CAR-T network, Autolus says its fully contained, semi-automated manufacturing process will increase efficiencies and reduce costs. Last June, Autolus Therapeutics raised $150 million (€132 million) in its initial public offering (IPO) with the intention of using some of the funds to support the manufacturing of its personalized Chimeric Antigen Receptor (CAR) T-cell therapy pipeline. In January, the UK-headquartered firm began building out a commercial manufacturing facility in Enfield, London, and signed a long-term full…

Celltrion injects $51m to get under the skin of infliximab competitors

Celltrion Pharm has pledged KRW 58.2 billion won ($51 million) to establish a production site for Remsima SC, a subcutaneous version of its Remicade biosimilar. Korean drugmaker Celltrion has achieved regulatory success for its biosimilar of J&J’s Remicade (infliximab) across several key markets and is now looking to receive approval and launch a subcutaneous version of the immunosuppressive monoclonal antibody. To prepare for launch, the firm has committed KRW 58.2 billion won ($51 million) to its site in Cheongju, South…

Adaptimmune on the merits of inhouse T-cell production

Adaptimmune says the only way an autologous T-Cell firm can control the evolution of production technologies is to have the process under its own roof. Adaptimmune Therapeutics began working with contract development and manufacturing organization (CDMO) PCT – now known as Hitachi Chemical Advanced Therapeutics Solutions (HCATS) – in 2013 and entered into a five-year strategic partnership in 2016 for the manufacture of its autologous SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell cancer immunotherapies. But the firm has also been…

NASA teams with Pluristem for cell therapy space program

NASA will conduct studies assessing Pluristem’s placental-derived cell therapies in astronauts who are planning space travel. NASA’s Ames Research Center has been awarded a 2019 NASA Ames Research Innovation Award (ARIA) to look at how Pluristem Therapeutics’ cell therapies can tackle serious medical conditions during travels in space. “During space missions, astronauts are exposed to a challenging environment, which could lead to serious medical conditions, including muscle atrophy,” Efrat Kaduri, a spokesperson from Pluristem, told BioProcess Insider. “Given the promising…

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…