Author Archives: Dan Stanton

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

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

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…

Bioreactors from Ireland to China: ABEC gains second license

ABEC has received approval to supply bioprocessing equipment to China from its facility in Kells, Ireland. Bioreactor and bioproduction equipment vendor ABEC has been supplying the Chinese market for the best part of a decade, after its Springfield, Missouri facility obtained a China Manufacture License (CML) in 2010. Now the firm can supply its tech from a second facility, the Kells plant in County Meath, Ireland, after the government granted the plant a China Manufacture License (CML) to manufacture pressure…

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

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…

US made biosimilars: Competitive advantage or marketing spin?

Coherus says American healthcare providers and payers favor biosimilars made in the US over those made overseas. But an industry analyst has dismissed this saying location should not matter provided the facility is approved. Coherus’ second quarter 2018 contained several regulatory milestones relating to its candidate Udencya (pegfilgrastim-cbqv), a biosimilar candidate to Amgen’s Neulasta. A resubmission to the US Food and Drug Administration (FDA) was accepted in May, while in July Europe’s Committee for Medicinal Products for Human Use (CMPH)…

WuXi Biologics launches bispecific antibody tech

WuXi Biologics says it can expedite the development of bispecific antibodies by up to 18 months compared to current offerings through its new ‘WuXiBody’ platform. The Chinese contract development and manufacturing organization (CDMO) WuXi Biologics announced the additional service offering during its 2018 interim results and said its proprietary tech can potentially transform the bispecific industry. “We can take any two sequences of the MAbs [monoclonal antibodies] and engineer into WuXiBody bispecific in two to three months. The resulting bispecifics…

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

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…

Oxford Genetics: CRISPR patent war casts shadow over use in cell line development

CRISPR engineered mammalian cell lines are more cost effective than other gene editing platforms says Oxford Genetics, but adopting such tech is perceived a risk due to ongoing patent issues. Oxford, UK-based synthetic biology firm Oxford Genetics has inked a multi-billion-dollar deal with an undisclosed ecommerce provider of reagents and tools for its high throughput automated genomic engineering platform for CRISPR modification of mammalian cell lines. While details are undisclosed, the deal shows how the firm has harnessed the gene-editing…

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

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…