Author Archives: Gareth Macdonald

Tech JV will help cell and gene therapy firms commercialize, say founders

Bio-Techne, Fresenius Kabi, and Wilson Wolf have partnered to cell and gene therapy developers commercialize their products. The joint venture – ownership of which will be split equally – will offer scalable manufacturing technologies and process development know-how to biopharmaceutical developers on a contractual basis. Specifically, Wilson Wolf will contribute its G-Rex cell therapy generation platform, while Bio-Techne will provide its range of proteins, reagents, media, and gene-editing technologies. Fresenius Kabi’s Lovo cell processing system will be available to developers…

Trump tax and pipelines behind Lilly’s $470m NC injection

Eli Lilly says its injectables pipeline and Trump-era tax laws prompted the decision to build new plant in North Carolina. Earlier this week Lilly announced it would build an injectable drug manufacturing facility in Durham County, North Carolina as part of a $470 m investment. The facility located at Research Triangle park will make injectable drugs and delivery devices according to Lilly, which said it expects to create more than 460 new jobs. A Lilly spokeswoman told us “The new…

GE Healthcare building Swiss cell processing kit plant

GE Healthcare Life Sciences says a single-use kit plant it is building in Grens, Switzerland will serve cell and gene therapy firms in the EU and beyond. The 7,360 square meter facility will be located in Grens near the French border. According to GE Life Sciences the facility will meet global regulatory requirements. A spokesperson told us: “The new site will manufacture the single use kits for Sepax and Sefia cell processing systems and will allow us to increase our…

Celltrion outlines 120,000L China plant and corporate rejig

Celltrion has confirmed it will build a biosimilars plant in China and may merge its healthcare and pharma units. A spokesman told Bioprocess Insider: “Celltrion plans to build a plant in China in a move to directly advance into the world’s second-largest biopharmaceutical market. Celltrion signed a business agreement with the city government of Wuhan and the provincial government of Hubei Province on 20 January 2020. “The company’s business roadmap centers on building a plant with a production capacity of…

Regeneron lays down the bispecifics at JP Morgan

Regeneron says it can now roll out a lot more bispecific antibody-based therapies including a new class of costimulatory bispecifics. Regeneron just rejigged its Praluent and Kevzara co-marketing deal with Sanofi. The “simplified” accord was covered at the JP Morgan healthcare conference last week. However, Regeneron devoted much more of its presentation to bispecific antibodies. CEO Len Schleifer told delegates progress made by two bispecific drug candidates – REGN1979 and REGN5458 – were indicative of the utility of its VelocImmune and…

Sarepta plans gene editing center; files DMD therapy for review

Genetic disease-focused firms need infrastructure says Sarepta, which shared plans for a gene editing center of excellence at the JP Morgan healthcare conference. The gene editing center will be in Durham, North Carolina according to CEO Douglas Ingram, who said investing in capacity and knowhow is key to Sarepta’s longevity. “If one is going to be an enduring genetic medicine company, we are going to need infrastructure,” he said, citing partnerships as an important part of the expansion. “We’re deepening…

Horizon says base editing tech could make cell therapies safer

Horizon Discovery Group says a new DNA editing tech could move multi-gene knockout cell therapies through trials with improved safety profiles. The technology in question – called the Pin Point system – is an editing platform that allows developers to precisely modify DNA at the base-level. The approach differs from CRISPR/Cas9 and other conventional editing techniques that create cuts in genes, which could result in unintended changes and lead to deleterious effects in patients Horizon says. The firm will offer…

Yposkesi to make Genethon and Sarepta’s DMD gene therapy

Genethon and Sarepta have contracted Yposkesi to make AAV material for a Duchenne muscular dystrophy (DMD) gene therapy they are developing. The therapy in question is called GNT0004. It consists of an AAV-type viral vector and a shortened version of the dystrophin gene (microdystrophin). According to preclinical data published in the journal Nature the therapy is able to produce significant restoration of muscle function with stabilization of clinical symptoms. Under the new manufacturing deal Yposkesi will produce clinical and large-scale…

UMass Lowell opens pilot freeze-drying development lab

UMass Lowell has opened a lyophilization testing facility where researchers and biopharma can develop freeze-drying processes in a non GMP environment. The facility – dubbed LyoBay – is located in the Mark and Elisia Saab Emerging Technologies and Innovation Center at UMass Lowell, which is located northwest of Boston. It is intended as a development space for scientists and biopharmaceutical companies according to executive director, Karen Hamlin. “The LyoBay offers users the opportunity to take their product technology from the…

iBio aims to cut manufacturing costs and improve data management with AI

iBio will use blockchain tech to cut costs and improve traceability in a deal that may also see Mateon spin-out a biopharma AI specialist. Plant-based biologics CDMO iBio asked EdgePoint AI – a unit of Mateon Therapeutics – to install artificial intelligence (AI) technologies at its manufacturing facility in Bryan, Texas. The idea is that the systems – known as TrustPoint Vision Fabric and TrustPoint Smart Protocols – will monitor production operations conducted and store data in a “blockchain.” Cost savings…