Author Archives: Dan Stanton

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,…

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…

Changing Regulations and ‘Sea Turtles’ Drive China Biotech Boom

Backed by US$260 million, Brii BioSciences is the latest firm benefiting from regulatory and economic changes in China. Insider spoke with expert David Deere to discover why the Chinese market is finally opening up. Funded by a group of six venture capitalists firms, Brii Bio is the latest, and one of the largest, examples of the surge of investment and innovation in Chinese biotech. “Brii Bio aims to accelerate the development and delivery of breakthrough medicines in China through partnerships,…

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,…

‘There is No Life Sciences Equivalent of Apple,’ Horizon Discovery’s New CEO

Horizon Discovery’s new CEO Terry Pizzie says the rate of technology evolution is greater than at any other time in his illustrious career as he reflects on the state of the bioprocessing services industry. Terry Pizzie joined Horizon Discovery Group in 2017 as head of commercial operations, but in May this year he was appointed to the top job. Pizzie has worked in life sciences for close to 30 years and spoke with BioProcess Insider about the changes he has…

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…