Author Archives: Dan Stanton

Teva Migraine MAb Approval Reliant on Celltrion Plant Fix

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

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…

eBook: The Future of Monoclonal Antibody Manufacturing — Incremental Improvement or Industrial Revolution?

Monoclonal antibody manufacturing is at a crossroads. Biomanufacturers could continue exploring new technologies and fine-tuning proven systems such as mammalian cell expression systems in stirred-tank bioreactor fed-batch cultures. But some experts say an opportunity is arising to turn the industry on its head by taking lessons from other branches of bioprocessing, such as the industrial enzyme sector. Drug makers are criticized often these days for the high prices of their products. The lay media, governments, payers, and patients themselves all…

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…

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

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…

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…

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

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

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…