Author Archives: Dan Stanton

Takeda divesting former-Shire $400m plant with 200 staff in Ireland

Takeda has identified a biomanufacturing facility in Dunboyne, Ireland as no longer required in a strategic review of its production network following the acquisition of Shire. In January 2019, Takeda completed its $62 billion (€56 billion) acquisition of Shire. As part of its integration, the firm said it intended to divest up to 25% of the combined business. Part of this strategy includes a biologics facility in Dunboyne, County Meath Ireland. “A strategic review of Takeda’s global biologics manufacturing network,…

Potential Oklahoma anti-vax bill danger to health and industry

Oklahoma has introduced a bill intended to ban the state from prescribing, administering, and making medicinal products and vaccines containing human DNA. Introduced on January 15, Senate Bill 1514 is proposing prohibiting vaccine use and supply in the state of Oklahoma. “No medicine, medical product, vaccine or other injection that contains human DNA shall be prescribed, administered, dispensed, used or offered in this state,” the bill states, placing a date of November 1, 2020 as the when it hopes to…

CAR-T at the Crossroads: Is Allogeneic the Way to Go?

As cell therapies move through the clinic toward commercialization, respondents to an Informa Connect industry survey are beginning to look to allogeneic — or off-the-shelf — products as “the next big thing.” Almost 200 people contributed to the Cell Therapy Analytics Report, revealing their current positions within the burgeoning cell and gene therapy space and offering their thoughts and predictions for the future. Most survey respondents work within companies developing oncology products. Of those, the largest group (41%) said that…

Sartorius ready to snap up more Danaher and GE’s assets, if required

Sartorius is poised to further expand its life science portfolio to help facilitate the Danaher and GE Healthcare merger if antitrust authorities deem more divestments necessary. In February 2019, Danaher entered an agreement to acquire the BioPharma portion of GE Healthcare’s Life Sciences business for $21.4 billion (€19.4 billion). Nearly a year on and the deal is yet to have been approved by antitrust regulators. Danaher has had to divest various life science assets to help ease the merger, with…

VGXI to make DNA vaccine in global effort to stymie coronavirus

VGXI will make Inovio Pharmaceuticals’ investigational vaccine as part of a collaborative effort to halt the progress of the coronavirus that has recently emerged in Wuhan, China. At the time of publication, 170 people have died and almost 8,000 people infected by the novel coronavirus (2019-nCoV). Wuhan, the Chinese city where the outbreak began, is under lockdown but cases of infection have been reported across the globe, including in Australia, France, and the US. There is no specific treatment for…

‘Lack of good CDMOs’ factor for Krystal’s $90m gene therapy plant

Krystal Biotech has broken ground on a commercial gene therapy manufacturing facility in Findlay Township, Pennsylvania. The 100,000 square-foot ‘ASTRA’ facility, set to create 75 jobs in the Pennsylvanian town, is expected to open in late 2021 to support Krystal Biotech’s gene therapy pipeline. Krystal is developing several ‘off-the-shelf’ gene therapies for rare skin diseases using its Skin TARgeted Delivery (STAR-D) platform consisting of an engineered HSV-1 vector and skin optimized gene transfer technology. Lead candidate B-VEC (previously known as…

Ori: ‘Partnerships key to bring down cell therapy COGS’

Ori Biotech estimates its automated and closed manufacturing platform can reduce COGS for autologous cell therapies by 60-80% and has teamed with HCATS to help take it to the clinic. One of the key takeaways from this year’s Phacilitate conference last week was the need for partnerships and collaboration to overcome the many issues currently plaguing the cell and gene therapy space, and specifically manufacturing. One such collaboration is between Hitachi Chemical Advanced Therapeutics Solutions (HCATS), the contract development and…

Top 10 advanced therapy milestones of 2019: Patient access takes center stage

CRISPR, capacity, and consolidation powered the cell and gene therapy space in 2019, but a proactive focus on patient access topped Falcon Therapeutics CEO Susan Nichols’ annual roundup. In what has become one of the most anticipated presentations at the Phacilitate conference, Susan Nichols, CEO of cell therapy firm Falcon Therapeutics, laid out the top 10 events of the previous year that have shaped the regenerative medicine space, driving conversation, investment, and innovation. The top spot in 2019 focused on…

CDMO aims ‘big’ in $1.2bn push to deliver capacity to cell & gene space

The newly formed Center for Breakthrough Medicines is building what it claims to be the world’s largest third-party cell and gene production facility at an ex-GSK site in Pennsylvania. For the production of cell and gene therapies, size matters, according to Brian O’Neill, founder of the Discovery Labs. He announced this week at the Phacilitate Conference in Miami, Florida that a 680,000 square-foot facility at a site in King of Prussia, Pennsylvania – a former GSK R&D campus sold to…

Thermo Fisher envisions 25% annual growth for gene therapy biz and no slowdown

Thermo Fisher claims to be the “leading outsource provider of viral vector manufacturing,” nine months after entering the space through the acquisition of Brammer. In March 2019, Thermo Fisher expanded its presence in the CDMO space by announcing plans to buy viral vector manufacturer Brammer Bio. Weeks later, the $1.7 billion deal closed, propelling Thermo Fisher into the gene therapy manufacturing space. Nine months on and Thermo Fisher CEO Marc Casper said the business has “got off to a good…