Author Archives: Dan Stanton

Astrea arises from the Prometic ashes; inks column deal with Thermo

Astrea Bioseparations will supply prepacked chromatography columns to Thermo Fisher. Formerly known as Prometic Bioseparations, the firm now forms part of KKR life sciences tool platform Gamma Biosciences. Late last year, Bioprocess Insider reported the planned acquisition of Liminal BioSciences’ chromatography and bioprocessing business Prometic Bioseparations by investment firm KKR in a deal worth up to £77 million ($100 million). Now complete, KKR has announced the firm will now be known as Astrea Bioseparations Ltd and is the first company…

Merck: 2023 the inflection point to address Gardasil demand

Two new bulk manufacturing facilities will come online by 2023 to feed the “incredible” global demand for HPV vaccine Gardasil, says Merck & Co. CEO Ken Frazier. Merck & Co. – known as MSD outside of North America – has for some time highlighted the human papillomavirus (HPV) vaccines Gardasil and Gardasil 9 as products with dominant near-term commercial potential. While the two vaccines pulled in $3.2 billion (€2.9 billion) in global sales in 2018, the Big Biopharma firm has spoken…

Tessa and CellVec both set up Singapore plants to support cell & gene therapies

Tessa Therapeutics will open a plant in Singapore for its CAR-T programs, while CellVec has opened a viral vector facility on the island state to support customers’ gene therapy projects. Singapore-based biotech Tessa is developing its own autologous cellular therapies and has told us it plans to open a 90,000 square-foot plant to support clinical and commercial efforts. “Tessa will use the new facility for the clinical and future commercial manufacturing of our late-stage clinical programs,” the firm said, adding…

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…