Facilities & Capacity Archives - Page 68 of 73 - BioProcess InternationalBioProcess International

AGC Bio adding 12,000L of ‘competitive and flexible’ capacity in Denmark

The CDMO will add six 2,000 L single-use bioreactors in Copenhagen and says such a configuration can be competitive compared with an equivalent scale stainless-steel run. A single-use bioreactor 6Pack suite, consisting of six 2,000 L bioreactors and a 2000 L seed train, is to be installed at AGC Biologics’ biomanufacturing plant in Copenhagen, Denmark. According to AGC’s chief business officer Robert Broeze, the ‘6pak’ set-up – consisting of the six bioreactors configurated to run consecutively to produce a total…

Samsung BioLogics says biosimilars important to utilize growing capacity

by Dan Stanton

Samsung BioLogics has begun making biosimilar versions of Enbrel and Remicade for its joint venture Samsung Bioepis, the Korean press reports. South Korean news portal BusinessKorea reported recently that contract development and manufacturing organization (CDMO) Samsung BioLogics has begun pilot production of two products on behalf of customer and joint venture entity Samsung Bioepis. The project sees the firm produce small scale amounts of Benapali and Flixabi, versions of Amgen’s Enbrel (etanercept) and J&J’s Remicade (infliximab) both approved across numerous…

Novartis constructing $92m CAR-T plant as Kymriah arrives in EU

by Dan Stanton

Up to 450 jobs will be created as Novartis commits to a production site for cell and gene therapies in Switzerland. The investment will support CAR-T drug Kymriah, which received European approval this week. A year after the US Food and Drug Admistration (FDA) approved Kymriah (tisagenlecleucel), the European Commission (EC) has granted the Novartis’ therapy approval to treat B-cell acute lymphoblastic leukemia (ALL). In the US, the chimeric antigen receptor T cell (CAR-T) product is manufactured at Novartis’ Morris…

Freedom of innovation: GE opens $17m Swedish biotech testing center

by Dan Stanton

For around $6,600 per week, firms will have access to bioprocessing laboratories and equipment to test their biotech innovations. “The innovative and entrepreneurial environment also provides important input to the GE culture,” says GE Healthcare. A €10 million ($11.6 million) investment by the Swedish government coupled with €4.5 million from life sciences vendor GE Healthcare has led to the opening of an innovation testing center at the latter’s site in Uppsala, Sweden. Named the Testa Center, the facility allows access…

Mustang to make ‘bubble boy’ candidate from newly opened cell therapy plant

by BPI Staff

A gene therapy for children with X-linked severe combined immunodeficiency (X-SCID) will be made at Mustang Bio’s facility in Massachusetts, which opened in June. Biotech firm Mustang Bio has partnered with St. Jude Children’s Research Hospital to develop a lentiviral gene therapy for the rare disease, commonly known as bubble boy disease, caused by a lack of immune cells necessary to fight off viruses, bacteria and fungi. As the therapy progresses through early-phase clinical trials, Mustang will begin to manufacture…

Bavarian Nordic: €30m loan to support smallpox vaccine fill/finish plant

by Dan Stanton

The loan will support construction of a facility aimed at bringing the full production of Imvamune in-house. The news comes a year after Bavarian Nordic won a US$539 (€472) million contract to supply the freeze-dried smallpox vaccine to the US government. Danish biotech Bavarian Nordic secured the loan from the European Investment Bank. During its second quarter results, CEO Paul Chaplin said the loan both secures the firm’s cash position and supports investments in its manufacturing network. This includes production…

Ex-Shire director to aid Catalent’s shift to commercial manufacturing

by Dan Stanton

The new general manager at Catalent’s facility in Wisconsin says his experience at Baxter and Shire will help the plant transition towards commercial manufacturing. Contract development and manufacturing organization (CDMO) Catalent has appointed Graham Brearley as general manager of its Madison, Wisconsin facility. With over 25 years’ of technical, operations and business experience in the biopharmaceutical industry, BioProcess Insider spoke to him about his move to a third-party services firm and his vision for Madison – and Catalent – going…

Jazz scales back Erwinaze push due to manufacturing disruptions

by Dan Stanton

To minimize impact on patients, Jazz Pharmaceuticals has reduced promotion of its cancer drug due to continued manufacturing issues at its CMO Porton Biopharma Limited (PBL). Erwinaze (asparaginase Erwinia chrysanthemi), an asparaginase enzyme derived from the bacteria Erwinia chrysanthemi, is used for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. The product is made for Jazz Pharmaceuticals by Wiltshire, UK-based and UK-government backed biomanufacturer PBL. However, the US Food and Drug…

Emergent: $270m PaxVax acquisition and Baltimore expansion boost CDMO biz

by BPI Staff

Emergent adds its first European biomanufacturing facility through the acquisition of vaccine maker PaxVax. Meanwhile in Baltimore, the firm has announced a $50 million fill/finish expansion. The US$270 million (€236 million) adds two vaccines approved by the US against cholera and typhoid fever to Emergent BioSolutions’ portfolio, along with several candidates including an Adenovirus 4/7 vaccine being developed for military personnel under contract with the US Department of Defense (DoD). The acquisition also brings Emergent its first biomanufacturing facility outside…

Celltrion receives FDA 483 with 8 ‘manageable and correctible’ observations

by Dan Stanton

Celltrion has received a US FDA Form 483 at its troubled biomanufacturing plant in Korea with eight observations not raised in a previous warning letter. In January, the US Food and Drug Administration (FDA) sent Korean drugmaker Celltrion a warning letter highlighting “multiple poor aseptic practices” at its production site in Songdo, Incheon. An FDA reinspection last month has now resulted in a Form 483 with eight observations. The 483 itself, uploaded by the Agency, cites issues with Celltrion’s drug product and…