Author Archives: Dan Stanton

Exclusive: Samsung BioLogics poised to enter cell therapy space

After building three large-scale biomanufacturing plants, CDMO Samsung BioLogics has told BioProcess Insider it is adding single-use capacity and is considering expanding into stem cell therapy services. It has been nine years since Samsung BioLogics entered the third-party biologics space, in which time it has brought two commercial biomanufacturing facilities online with a third expected to be fully validated by the end of this year. When operational, the firm’s site in Incheon, South Korea will boast a total of 362,000…

Sanofi deal shows demand for CHO alternatives, says Dyadic

Sanofi-Aventis Deutschland has teamed with Dyadic to test the potential of the C1 fungus-based expression system for the manufacture of biologics and vaccines. The fully funded proof of concept research deal will see Sanofi-Aventis use Dyadic International’s C1 platform to overcome specific gene expression challenges across some of its vaccine and protein-based biologics “Sanofi sees huge value in C1 and the future of bioprocessing and biomanufacturing efficiencies with such a power horse and we are excited for the collaboration as…

Thermo Fisher back on the M&A train through BD buy

The addition of BD’s Advanced Bioprocessing business will boost Thermo Fisher Scientific’s cell culture media formulations offering. At the BioProcess International Conference in Boston, Massachusetts last week, news broke that equipment and reagent supplier Thermo Fisher agreed to buy the Advanced Bioprocessing business of medtech firm Becton, Dickinson and Company (BD). The business, which clocks in around $100 million (€86 million) annually, will add several peptones that enhance cell culture media formulations, aimed at improving yield and reduce variability in…

Sanofi prepped for production after EU Nanobody success

Ten weeks after acquiring Ablynx, Sanofi has received European approval for lead Nanobody-based drug Cablivi (caplacizumab). In June this year, Sanofi acquired Belgian biotech Ablynx for €3.9 billion ($3.5 billion), adding the firm’s pipeline of biotherapeutics based on the small-sized antibody, or Nanobody, technology. Now the French biopharma firm is set to commercialize lead product caplacizumab (anti-vWF Nanobody) in Europe under the brand name Cablivi after the European Commission granted it marketing authorization for the treatment of rare blood-clotting disorder…

BioMarin building $50m Irish fill/finish plant for orphan enzymes

The drug product plant in County Cork will support the fill and finish of BioMarin’s rare disease drugs Vimizim (elsulfase alfa) and Brineura (cerliponase alfa). The filling facility at BioMarin’s site in Shanbally, County Cork represents an investment of €43 million ($50 million) and will create 51 additional jobs. “We regularly evaluate our manufacturing capabilities and which capabilities we do ourselves and which make sense to outsource,” BioMarin spokesperson Debra Charlesworth told BioProcess Insider. “Based on our current business needs…

Vendors ‘awakening’ to the needs of cell and gene therapy makers

Equipment suppliers are vying to fill gaps in processing say cell and gene therapy experts, but understanding what end-users need will be central for success. In 2017, the US FDA approved two chimeric antigen receptor T (CAR-T) cell therapies. Since then there have been several other cell and gene therapies approved across several markets, including Europe’s first allogeneic stem cell in the form of Takeda’s Alofisel (darvadstrocel). And with several hundred cell and gene candidates moving through the clinical stages…

Sartorius combination tech deal a ‘win-win,’ says Repligen

Bioprocessing vendors Sartorius Stedim Biotech and Repligen Corporation have combined their bioreactor technologies to offer control integrated bioreactors for perfusion. Announced at the BioProcess International Conference in Boston this week, Sartorius and Repligen have inked a deal to integrate their respective technologies into a combined offering for biomanufacturers. Under terms of the deal, Repligen’s XCell ATF cell retention control technology will be combined into Sartorius’ BIOSTAT STR large-scale single-use bioreactors offering customers bioreactors used in perfusion cell culture applications between 50…

False biosimilar communications: Originators rebuff Pfizer’s claims

Pfizer has accused Amgen, J&J and Roche of sending misleading communications about biosimilars in a Citizen Petition asking the US FDA to issue guidance on such behavior. In a Citizen Petition published on August 22, Pfizer said communication tools intended to incentivize the adoption of and switching of biosimilars have led to a robust uptake of biosimilars in Europe, but in the US “payer reimbursement policies are in fact impeding adoption of biosimilars.” The firm continued: “Dissemination of false or misleading…

With third bio-train complete, Catalent eyes fourth and fifth in Wisconsin

CDMO Catalent is considering adding two more manufacturing trains at its Madison facility due to anticipated demand for sub-5,000 L biomanufacturing. For Catalent’s fourth quarter FY2018, sales from its Biologics and Specialty Drug Delivery business stood at US$196 million (€168 million), twice that of the same period last year. The contract development and manufacturing organization (CDMO) attributed much of this increase to the acquisition of Cook Pharmica and the addition of a biomanufacturing facility in Bloomington, Indiana. However, management told…

Gilead says CA plant will supply Yescarta to EU until 2020

Kite’s manufacturing plant in El Segundo, California, will supply Europe with the newly approved CAR-T therapy Yescarta while a facility in The Netherlands is being prepared. Gilead Sciences has received marketing authorization from the European Commission (EC) for its chimeric antigen receptor T (CAR-T) cell therapy Yescarta (axicabtagene ciloleucel). The therapy is approved to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL). “Across the European Union, it is estimated that…