Facilities & Capacity Archives - Page 71 of 73 - BioProcess InternationalBioProcess International

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…

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

by BPI Staff

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…

Teva Migraine MAb Approval Reliant on Celltrion Plant Fix

by Dan Stanton

FDA approval of Teva’s fremanezumab depends on a speedy resolution of a plant run by CMO Celltrion but this is looking increasingly likely, an analyst says. The US Food and Drug Administration (FDA) had set the Prescription Drug User Fee Act (PDUFA) action date for fremanezumab, a humanized monoclonal antibody targeting calcitonin gene–related peptide (CGRP) for mid-June. But Teva Pharmaceutical Industries envisioned a delay after its contract manufacturer Celltrion received an FDA warning letter in January. Celltrion’s site in Incheon,…

Topical Herpes Virus-Based Gene Therapy Granted FDA Fast Track

by Dan Stanton

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

by Dan Stanton

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…

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

by BPI Staff

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…

WuXi Biologics: Zero to 220,000L of Capacity in 10 Years

by Dan Stanton

WuXi Biologics has invested US$60 million to build a biomanufacturing facility in Singapore. By 2022, the CDMO will have 10 plants – an achievement it attributes to disposable and modular technologies. WuXi Biologics has announced plans to add a S$80 million (US$60 million) clinical and commercial biologics manufacturing in Singapore to its growing global network. When operational, the site will boast 4,500 L biomanufacturing capacity comprised of two 2,000 L traditional fed-batch and one 500 L perfusion based continuous processing…

Novasep Invests in Belgian Fill & Finish Site; Cites Lack of Global Capacity

by BPI Staff

The tension on the market surrounding the lack of fill & finish capabilities is ‘visible,’ says Novasep as it pumps US$12 million into a site in Belgium. The investment at Novasep’s site in Seneffe, Belgium will support the fill & finish for viral vectors, mAbs and other low-volume biologics. According to Laure Saloin, a spokesperson from the French life sciences services firm, the €10 million (US$11.8 million) spend supports the “one-stop-shop approach for our monoclonal antibodies and our viral-vectors bulk…

Multi-Media Player: GE Invests in EU and US Plants to Tap $1.4bn Market

by Dan Stanton

The increased demand for cell growth media from biomanufacturers has driven capacity expansions at sites in Utah and Austria, says GE Healthcare. Globally, GE Healthcare has cell culture media production in Tuas (Singapore), Pasching (Austria), and Logan (Utah, US). To support growing demand from the biopharma industry, the life sciences firm has announced capacity expansions at the two latter plants. “Cell culture media is the fastest growing segment within the cell culture market and it was valued at US$1.4 billion in…

Gilead to Open European Plant to Support CAR-T Manufacture

by Dan Stanton

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…