Author Archives: Dan Stanton

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…

Jazz scales back Erwinaze push due to manufacturing disruptions

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…

YMC M&A: Lewa addition brings bioprocess tech and US market

Japanese separations resins firm YMC will buy the bioprocessing business of Lewa-Nikkiso America. The “friendly acquisition” includes a facility in Devens, Massachusetts. Privately-held Kyoto, Tokyo-based YMC will add a number of bioprocessing technologies through the acquisition, including staff and assets dedicated to the development, manufacture and sales of batch and continuous chromatography equipment, and buffer dilution systems for the biopharmaceutical market. Financial details have not been divulged. Gerard Gach, chief marketing officer at Lewa- Nikkiso America, told BioProcess Insider Lewa’s…

Samsung Bioepis: From biosimilars to novel biologics

Following success with several biosimilars, bringing a novel biologic into the clinic is the “next logical step” in becoming a fully integrated biopharma firm, says Samsung Bioepis. Almost a year to the date it announced a co-development agreement, Samsung Bioepis and Takeda Pharmaceuticals are preparing to begin a Phase I trial for its lead candidate, SB26, also known as TAK-671. The news signals the latest stage in the development of Samsung Bioepis – a joint venture between South Korean contract…

Alnylam’s success brings first RNAi therapeutic to US

The US Food and Drug Administration (FDA) has approved the first ever RNA interference (RNAi) therapy: Alnylam’s Onpattro (patisiran). Alnylam announced last week Onpattro has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The product was hailed by the FDA as the first in a new class of drugs: small interfering ribonucleic acid (siRNA) treatments. “New technologies like RNA inhibitors, that alter the genetic drivers of a disease, have the…