Author Archives: Dan Stanton

Sartorius Pumps $100m in Puerto Rico, Doubles SU Bag and Filter Capacity

North American demand for aseptic filters and single-use bags drove Sartorius to expand its facility in Yauco, Puerto Rico. German bioprocessing supplier Sartorius began expanding its Yauco production and distribution center in 2016 and has invested more than US$100 million (€86 million), according to spokesperson Timo Lindemann. The investment brings Sartorius an additional area covering nearly 190,000 square meters – around two million square feet – he told BioProcess Insider. “A focal area of investment will be on expanding aseptic…

Patheon On Keeping Up With Biologics Demand

  Patheon is doubling its biomanufacturing capacity through a $50 million investment in Missouri. We spoke with the CDMO about the continued demand for biologics services and its relationship with owner Thermo Fisher. In April, contract development and manufacturing organization (CDMO) Patheon announced plans to add 16,000 L of single-use capacity at its St Louis, Missouri facility. The US$50 million (€43 million) expansion effectively doubles the firm’s global biomanufacturing capacity. According to David Kenyon, senior director of Global Scientific and Technical…

Sanofi: ‘Ablynx Nanobody Tech Will Fuel Innovation’

Sanofi has completed the acquisition of Ablynx and says it will use the ‘small antibody’ tech platform to drive innovation across a range of therapeutic areas. After rebuffing offers from Novo Nordisk, Belgian biotech Ablynx agreed to an acquisition bid of €3.9 billion (US$4.5 billion) from Sanofi in January. This week, the French pharma giant closed the deal and spoke about its integration plans. “Sanofi and Ablynx have already initiated efforts to better understand the company’s respective areas of expertise…

Plant on the Road to Remediation as Celltrion Resubmits Biosimilars

Celltrion has completed the resubmission of versions of Herceptin and Rituxan to the US FDA after receiving complete response letters for the two biosimilars in April. Earlier this year, the US Food and Drug Administration (FDA) issued complete response letters (CRLs) to South Korean drugmaker Celltrion for its rituximab and trastuzumab biosimilars. The letters cited a warning letter​ sent to the firm in January highlighting “multiple poor aseptic practices” at its production site in Songdo, Incheon. The firm resubmitted CT-P10, a proposed biosimilar…

Lack of Interchangeable Biosimilars Keeps J&J in the Infliximab Game

While US infliximab biosimilars lack interchangeability approval, Remicade (infliximab) can continue to compete in an open market place, says Janssen. Pfizer launched its a biosimilar to Remicade (infliximab), Inflectra, in 2016. The following year, Samsung Bioepis/Merck & Co.’s Renflexis became the second direct threat to Johnson & Johnson subsidiary Janssen’s blockbuster monoclonal antibody. But both products, while deemed by the US Food and Drug Administration (FDA) to be biosimilar to Remicade, have not been approved to be interchangeable with the…

Sanofi Inks $850m mRNA Vaccines Deal with Translate Bio

Sanofi Pasteur has teamed with Translate Bio to develop messenger RNA (mRNA) vaccines for up to five infectious disease pathogens. Under terms of the deal, French vaccine developer Sanofi Pasteur will make an upfront sum of US$45 million (€38 million) to Massachusetts-based firm Translate Bio but total payments could reach $850 million on the back of developmental milestones and royalties. The R&D for the undisclosed vaccine targets will be jointly conducted during an initial three-year period. mRNA vaccines work by…

Benitec Scale-Up Success with Insect-Based Tech Ahead of IND Filing

Benitec Biopharma says it has successfully scaled-up its investigational oculopharyngeal muscular dystrophy (OPMD) gene therapy using a baculovirus-based expression system. Benitec Biopharma’s lead candidate BB-301 is a gene therapy for the treatment of oculopharyngeal muscular dystrophy (OPMD), a disease caused by a mutation of the poly(A)-binding protein nuclear 1 (PABPN1) gene. The candidate received orphan drug status from the US Food and Drug Administration (FDA) in January this year, and the firm hopes to bring it into the clinic by…

Coming to America: WuXi Biologics Expands Again

WuXi Biologics will construct its first biomanufacturing facility in the US. The US$60 million plant is the third overseas expansion announced in the past month by the Chinese CDMO. Chinese contract development and manufacturing organization (CDMO) WuXi Biologics has rapidly begun expanding its biomanufacturing capacity. A string of investments over the past few weeks will add new capacity in China as well as see the firm venture overseas, including in the US where a US$60 million (€51 million) plant in…

Longstanding Bio Partner Celltrion Launches Full CDMO Unit

The Korean firm, which boasts Teva and Pfizer as partners, has consolidated its third-party services to offer a full CDMO platform. Celltrion announced at BIO in Boston last week it is launching a “Bio CDMO” (contract development and manufacturing) business. According to the South Korean biologics maker, the service consolidates its current third-party offerings, combining cell line development and production process, with clinical and commercial biomanufacturing. Spokesperson Gunhyuk Lee told BioProcess Insider: “You could consider this CDMO business as a…

Media Control: Fujifilm Buys Irvine Scientific for $800m

The acquisition of cell culture media firm Irvine Scientific complements Fujifilm’s bioprocessing business and helps ensure supply chain control, the company told us at BIO. Fujifilm Corporation has completed the acquisition of Irvine Scientific (ISUS) and IS Japan (ISJ) for US$800 million (€680 million) from fellow Japanese-headquartered firm JXTG Nippon Oil & Energy Corporation. The deal, first announced in March, brings Fujifilm an increased presence in the life sciences service industry, adding a range of media for industrial cell culture,…