Therapeutic Class

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…

Automated Tech Ups Hitachi’s Cell Therapy Interest

Recent entrant to the regenerative medicine space Hitachi Chemical has partnered with Invetech to commercialize the Counter-Flow Centrifugation system – an automated platform for cell therapy manufacturing. The partnership will allow customers of Hitachi Chemical Advanced Therapeutics Solutions (HCATS) to access Invetech’s Counter-Flow Centrifugation (CFC) system in the clinical and commercial manufacturing of cell-based therapies using closed single-use disposables. Hitachi entered the regenerative medicine space in 2017 through the $US75 million (€64 million) acquisition of cell therapy contract development and…

Dyadic to Develop Biosimilars Using CHO-Challenging Expression System

Dyadic International has begun developing a pipeline of biosimilars using a fungal expression system it says achieves much higher productivity than CHO cell lines. Dyadic began looking to its enzyme production fungal expression technology for biopharmaceutical purposes in 2015 and has forged several sub-license and partnerships in the biologics space. But now the Florida-based firm has revealed it is set to develop its own biosimilar and biobetter pipeline using the expression system. “We began in earnest an R&D effort on…

First US Neulasta Biosimilar Approval on Second Try for Mylan

The FDA has approved the first US biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim). Mylan’s Fulphila is the tenth biosimilar to be approved in the US. Mylan’s biosimilar, developed with Indian biomanufacturer Biocon, will launch Fulphilia in the coming weeks, spokesperson Julie Knell told BioProcess Insider. “Mylan is the first company to obtain approval for a biosimilar version of Neulasta in the US. Other manufacturers have sought licensure from the FDA but, to our knowledge, do not yet have approval.” She…

Biosimilar Bulletin: EU Success for Sandoz, Amgen Stumbles Stateside

Sandoz says it will use a third-party manufacturer as its proposed Humira biosimilar receives recommendation in Europe. Meanwhile, the US FDA has rejected Amgen’s proposed Herceptin biosimilar. Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Halimatoz, Hefiya and Hyrimoz – all versions of AbbVie’s best-selling Mab Humira (adalimumab) submitted by Novartis subsidiary Sandoz. “To ensure the majority of eligible patients gain access to our biosimilar medicines as soon as possible,…

TxCell Opts for Lonza to Make CAR-Treg Clinical Batches

Lacking the resources to manufacture in-house, French biotech firm TxCell has chosen Lonza to produce its HLA-A2 CAR-Treg cellular product, TX200. In February, TxCell finalized its manufacturing process to make Tx200, and began transferring tech to its contract manufacturing organization (CMO). Now the French biotech has revealed the CMO is Lonza, which will manufacture clinical batches of the CAR-Treg product from its production site in Geleen, the Netherlands. TxCell CEO Stephane Boissel told Bioprocess Insider Lonza will produce Phase I/II…

Bavarian Nordic: Smallpox Vaccine Plant ‘Encouraged’ by US Government

Bavarian Nordic is constructing a US$75 million fill & finish facility in Denmark on the back of future US government contracts to supply smallpox vaccine Imvamune. Last September, the US government’s Biomedical Advanced Research and Development Authority (BARDA) awarded Danish vaccine manufacturer Bavarian Nordic a contract for the manufacturing and storage of its smallpox vaccine Imvamune. The deal, worth more than $539 million (€460 million), is the third such award to manufacture vaccine bulk to the US Department of Health…

Topical Herpes Virus-Based Gene Therapy Granted FDA Fast Track

Krystal Biotech’s lead candidate has received FDA fast track designation for the treatment of dystrophic epidermolysis bullosa (DEB). The firm is building a GMP facility in Pennsylvania to support future scale-up. The US Food and Drug Administration (FDA) granted fast track designation to KB103, a topically-applied gene therapy engineered to deliver a human collagen protein to patients suffering from DEB. The designation will help expedite the development and review process of the allogeneic gene therapy, and is a boost for…

Fujifilm Adds Automated Filler for Late-Stage Gene Therapies at Texas Plant

Recent gene therapy approvals have driven the demand for third-party services, says Fujifilm as it expands fill & finish capabilities at its recently opened site. In January 2018, Fujifilm Diosynth Biotechnologies opened an 80,000 sq-ft facility in College Station, Texas, for the manufacture of gene therapies. This week, the contract development and manufacturing organization (CDMO) has expanded the plant to support the fill & finish of Phase III and commercial products by adding a Vanrx Pharmasystems’ SA25 automated filler. “We…

Gilead Flies a Kite for ZFN Gene Editing Tech Over CRISPR

Gilead’s CSO spoke about its choice of zinc finger nuclease (ZFN) for ex-vivo gene editing at the Bank of America Merrill Lynch Healthcare Conference. In February, Kite Pharma – acquired by Gilead Sciences for US$11.9 billion in last August – struck a deal to use Sangamo Therapeutic’s ZFN technology to modify genes in the development of its autologous and allogeneic cell therapies. Kite/Gilead paid $150 million up front to the fellow Californian firm but Sangamo could be entitled to a…