Therapeutic Class

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…

Novartis Building $55m gene therapy plant, Creating 200 Jobs in NC

A week after buying AveXis, Novartis has announced plans to build a gene therapy manufacturing facility in Durham, North Carolina. On May 15, Swiss Biopharma Novartis confirmed the completion of the US$8.7 billion (€7.4 billion) acquisition of clinical stage gene therapy firm AveXis. A week later, Novartis has unveiled plans for a $55 million gene therapy production plant in Durham, North Carolina to support AveXis’ gene therapy pipeline targeting rare neurological genetic diseases. AveXis’ lead candidate AVXS-101, in development for…

Biogen Paying $650m to Up Stake in Samsung Bioepis

Biogen has opted to increase its control in biosimilar venture Samsung Bioepis to 49.5%, according to partner Samsung BioLogics. Biogen sent South Korean biomanufacturer Samsung BioLogics a letter last week declaring its intention to increase its stake in the firms’ joint venture Samsung Bioepis from 5.4% to 49.5%. According to Samsung BioLogics, Biogen will pay around 700 billion Won (US$650 million) for an additional 44.6% stake in the JV, with the deal expected to take two to three months to…

Coherus Resubmits Neulasta Biosimilar, Aims for November Approval

With successful preapproval inspections at its manufacturing sites, Coherus BioSciences is confident its CHS-1701 pegfilgrastim biosimilar will be approved by the end of the year. In 2017, California-based Coherus received a US Food and Drug Administration (FDA) complete response letter (CRL) for its version of Amgen’s Neulasta (pegfilgrastim), CHS-1701. The CRL requested a reanalysis of a subset of subject samples with a revised immunogenicity assay, along with additional manufacturing related process information. Earlier this month, Coherus announced it resubmitted its…

Gilead to Open European Plant to Support CAR-T Manufacture

The site near Amsterdam, The Netherlands will be Gilead Sciences/Kite’s third manufacturing facility to support production of its cell therapies. “The site in Hoofddorp will be Kite’s manufacturing base in Europe, enabling Kite to efficiently manufacture and deliver its cell therapies to people living with cancer in Europe,” Gilead spokesperson Sarah Swift told BioProcess Insider. When operational in 2020, the 117,000 ft2 site will provide 300 new jobs. Gilead Sciences entered the cell therapy space last August through the US$11.9…

Valerius Picks Catalent to Make ‘Specialty Biosimilar’ Pipeline

High productivities and specialized targets means Catalent’s 2,000 L scale bioreactors can easily realize production needs for its orphan biosimilar and biobetter candidates, says Valerius Biopharma’s CEO. Swiss biopharma firm Valerius Biopharma has selected Catalent Biologics to provide cell line development and cGMP manufacturing for its burgeoning biosimilar pipeline. The firm has not disclosed the specific targets but CEO Andreas Herrmann told BioProcess Insider “two are biosimilars of orphan drugs and the other two are products, where we want to…

First US Epogen Biosimilar Approved as Pfizer Fixes GMP Issues in Kansas

The FDA upgraded Pfizer’s troubled McPherson, Kansas facility in January paving the way for the approval of Retacrit – a biosimilar version of Amgen’s Epogen (epoetin alfa). The US Food and Drug Administration (FDA) approved Retacrit as the first biosimilar version of Amgen’s anemia drug Epogen yesterday. “The FDA’s decision to approve Retacrit for all indications of the reference product marks a critical and positive step forward in helping create a marketplace for biosimilars in the US, further advancing opportunities…