Author Archives: Dan Stanton

Coming to America: WuXi Biologics Expands Again

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WuXi Biologics will construct its first biomanufacturing facility in the US. The US$60 million plant is the third overseas expansion announced in the past month by the Chinese CDMO. Chinese contract development and manufacturing organization (CDMO) WuXi Biologics has rapidly begun expanding its biomanufacturing capacity. A string of investments over the past few weeks will add new capacity in China as well as see the firm venture overseas, including in the US where a US$60 million (€51 million) plant in…

June 11, 2018

Longstanding Bio Partner Celltrion Launches Full CDMO Unit

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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…

June 11, 2018

Media Control: Fujifilm Buys Irvine Scientific for $800m

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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,…

June 8, 2018

Dyadic to Develop Biosimilars Using CHO-Challenging Expression System

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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…

June 8, 2018

Changing Regulations and ‘Sea Turtles’ Drive China Biotech Boom

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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,…

June 6, 2018

First US Neulasta Biosimilar Approval on Second Try for Mylan

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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…

June 6, 2018

Biosimilar Bulletin: EU Success for Sandoz, Amgen Stumbles Stateside

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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,…

June 4, 2018

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

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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…

May 31, 2018

Teva Migraine MAb Approval Reliant on Celltrion Plant Fix

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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,…

May 29, 2018

Topical Herpes Virus-Based Gene Therapy Granted FDA Fast Track

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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…

May 28, 2018