Author Archives: Dan Stanton

Novartis opens its largest gene therapy plant to support Zolgensma

The doors have opened at a facility in Longmont, Colorado nine months after Novartis acquired it to support its gene therapy business unit AveXis. In April 2019, Novartis bought the Longmont facility from fellow Big Biopharma player AstraZeneca in efforts to grow out its gene therapy production network. Nine months on and the Swiss Biopharma has confirmed the site is open and prepped to support its AveXis unit in the production of therapies including Zolgensma (onasemnogene abeparvovec-xioi1), which was approved…

In with the new… Deal completions from Catalent, CRL and Janssen

It’s a happy new year for Catalent, Charles River and Janssen, which have closed their respective acquisitions of a fill/finish facility, cell therapy services firm and an investigative mAb. In December, Roche completed its $4.3 billion (€3.9 billion) acquisition of commercial gene therapy firm Spark Therapeutics, 10 months after the deal was announced. But the Swiss Biopharma is not the only firm to begin 2020 with new assets, as several others in the life science space have announced the completion…

GVK Bio looks to ‘big-ticket’ manufacturing after building up bioservices biz

GVK Bio says it is adding master cell banking services to get in the GMP mindset, with a longer-term goal to expand into clinical and commercial production. In 2014, Indian contract research organization (CRO) GVK Bio landed both in the US and in the biologics services space by acquiring Aragen Bioscience. Aragen comprises of two sites in San Francisco offering efficacy studies, protein analytics, and cell line development services. At the time, “Aragen’s scientific excellence and expertise in large-molecule R&D…

Twist to biopharma with Pandion antibody optimization expansion

Twist Bioscience will leverage its antibody optimization platform to help develop further autoimmune and inflammatory candidates for Pandion Therapeutics. The two firms have completed an initial project using Twist’s antibody optimization platform based on DNA sequencing technology and will now collaborate on further antibodies for autoimmune regulation. Twist Biopharma – a division of California-based Twist Bioscience – CEO Emily Leproust said the deal with Pandion “is an excellent example of how our antibody optimization solution can change the discovery and…

China Oks first CDMO-made MAb since Drug Administration law revision

China has approved tislelizumab, a drug for Hodgkin’s lymphoma developed by BeiGene and made locally by Boehringer Ingelheim. The monoclonal antibody (Mab) is the first biopharmaceutical approved under China’s recently modified Drug Administration Law (DAL). The law was revised in August introducing a marketing authorization holder (MAH) system similar to those in the US and EU. The revision also formalized rules governing contract manufacturing. Previously, regulatory approvals were contingent on the developer having its own manufacturing capacity in China. However, in 2015 the…

Biotech VC down 20% in US as policies drive away foreign investors, BIO

Reforms to a US national security regulation are putting off foreign investors and driving down VC investment in the biotech space by as much as 20 percent, says BIO’s David Thomas. In August 2018, Congress passed the Foreign Investment Risk Review Modernization Act (FIRRMA) as part of the Fiscal 2019 National Defense Authorization Act. The Act broadened the scope and oversight of the Committee on Foreign Investment in the United States (CFIUS) to include the review of foreign investments in companies…

Are you single-use or stainless-steel? Take our holiday quiz to find out

Does your heart beat when you see a large shiny tank fixed-fast to the wall of a giant redbrick facility, or do you get a warm feeling in your inside bioreactor when you see a plastic bag flexing its flexibility credentials across a modular cleanroom? It’s the end of the decade and while much has changed since December 2009, one of the biggest shake-ups in the bioprocess space is the advent of single-use systems. With single-use systems now being used…

Back to school: GE and UMass partner on academic viral vector plant

GE Healthcare has partnered with UMass to establish a viral vector manufacturing facility – its latest tie-in with academia in the cell and gene therapy space. The planned facility at the University of Massachusetts (UMass) Medical School’s Worcester campus will provide recombinant adeno-associated virus (AAV) vectors for preclinical research. High demand and a shortage of capabilities for viral vectors means the 3,220 square-foot facility, decked out with GE Healthcare’s viral vector FlexFactory platform, will help alleviate the current wait researchers…

Hemophilia A-OK! FTC thumbs up effectively closes Roche’s $4.3bn Spark buy

There is no risk of competitive harm between Roche’s approved hemophila A monoclonal antibody and Spark’s gene therapy candidates, say the US and UK competition bodies. In February, Swiss Biopharma firm struck a deal to buy Philadelphia, Pennsylvania-based Spark Therapeutics for $4.3 billion (€3.8 billion). Now after months of investigation by the US Federal Trade Commission (FTC), Roche is on the verge of closing the deal. The FTC’s concerns centered on the potential competitive harm of overlaps between Roche and…

Samsung BioLogics brings Berkeley Lights’ Beacon to Korea

Korean CDMO Samsung BioLogics will use the Beacon optofluidic platform to reduce cell line development timelines and boost its drug development services. Having first entered the contract development space in 2017, Samsung BioLogics has now inked a deal to use Berkeley Lights’ Beacon pre-programable and automated optofluidic platform to service its customers cell line and process development projects. The technology itself is based on a nanofluidic chip consisting of chambers in which cells are placed to be cultured and assayed,…