Author Archives: Gareth Macdonald

Akron says biopharma needs GMP framework for ancillary materials

Akron Biotechnology says biopharma needs a common GMP framework for ancillary materials used in the production of advanced therapies Ancillary materials (AMs) are components and reagents used during cell therapy production. They are not supposed to be present in the finished products, but often are which can impact quality and safety. Despite this, at present there are no specific regulations governing the composition, compliance, and qualification of AMs. Instead there are several independent GMP frameworks for such materials. These include…

Thermo says Chinese Gov policy will drive growth

Thermo Fisher Scientific says Chinese Government support for biopharma will help grow its business in the country. The life science services, tools and technology firm saw full-year revenue increase 5% to $25.54 billion in 2019 according to documents filed with the US SEC last week. The contribution from Thermo’s operations in China increased 13% year-on-year. And China was a major topic of discussion for CEO Marc Casper during Thermo’s fourth quarter call. “Government priorities in China are aligned with the…

US FDA predicts gene therapy surge and moves to clarify expectations

Gene therapy developers targeting the US market have a clearer idea of what it will take to win approval thanks to new guidance documents issued by the FDA. The US regulator set out its expectations for developers in six documents published last week. There are final guidance documents on gene therapies for hemophilia, retinal disorders and rare diseases. In addition, there are final guidance documents on chemistry, manufacturing and controls (CMC), observational studies and on the assessment of gene therapies…

Repligen fighting fit in $10bn bioprocess sector, eyes CGT for growth

Repligen says planned tech launches and growing cell and gene therapy sector demand will drive market expansion and growth in 2020. The bioprocess and life science tech supplier shared its thoughts at the JP Morgan Healthcare conference. CEO Tony Hunt said a “surge” in clinical activity is driving expansion in the CDMO space – citing announcements by Catalent and Thermo Fisher Scientific – and at large pharma firms like Amgen, Novartis and BeiGene. “If you go back a few years…

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…