Upstream & Downstream Processing

Patheon On Keeping Up With Biologics Demand

  Patheon is doubling its biomanufacturing capacity through a $50 million investment in Missouri. We spoke with the CDMO about the continued demand for biologics services and its relationship with owner Thermo Fisher. In April, contract development and manufacturing organization (CDMO) Patheon announced plans to add 16,000 L of single-use capacity at its St Louis, Missouri facility. The US$50 million (€43 million) expansion effectively doubles the firm’s global biomanufacturing capacity. According to David Kenyon, senior director of Global Scientific and Technical…

Benitec Scale-Up Success with Insect-Based Tech Ahead of IND Filing

Benitec Biopharma says it has successfully scaled-up its investigational oculopharyngeal muscular dystrophy (OPMD) gene therapy using a baculovirus-based expression system. Benitec Biopharma’s lead candidate BB-301 is a gene therapy for the treatment of oculopharyngeal muscular dystrophy (OPMD), a disease caused by a mutation of the poly(A)-binding protein nuclear 1 (PABPN1) gene. The candidate received orphan drug status from the US Food and Drug Administration (FDA) in January this year, and the firm hopes to bring it into the clinic by…

Coming to America: WuXi Biologics Expands Again

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…

Automated Tech Ups Hitachi’s Cell Therapy Interest

Recent entrant to the regenerative medicine space Hitachi Chemical has partnered with Invetech to commercialize the Counter-Flow Centrifugation system – an automated platform for cell therapy manufacturing. The partnership will allow customers of Hitachi Chemical Advanced Therapeutics Solutions (HCATS) to access Invetech’s Counter-Flow Centrifugation (CFC) system in the clinical and commercial manufacturing of cell-based therapies using closed single-use disposables. Hitachi entered the regenerative medicine space in 2017 through the $US75 million (€64 million) acquisition of cell therapy contract development and…

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…

‘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,…

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…