Author Archives: Dan Stanton

Catalent adds early-stage plant to its blooming(ton) fill/finish business

CDMO Catalent says it is looking to serve fill and finish demand for early-phase customers in its $14 million acquisition of a second facility in Bloomington, Indiana. Three years after AB BioTechnologies broke ground on a 23,000 square-foot facility, fellow contract development and manufacturing organization (CDMO) Catalent has acquired it for $14 million – $3.5 million more than the 2017 investment. The facility adds clinical and small-scale commercial manufacturing for injectable drugs to Catalent’s growing fill and finish network and…

Combined Therapeutics wins $250,000 MilliporeSigma Advance Biotech Grant

MilliporeSigma has awarded MIT spin-out Combined Therapeutics a cheque for $250,000 as the winner of its 2020 Advance Biotech Grant. Combined Therapeutics (CTx) is an early stage startup developing next generation virotherapies targeted with nucleic acids. The pre-clinical biotech aims to develop therapies to treat liver cancer using its targeted oncolytic platform. The firm – founded by MIT professors Robert Langer and Dan Anderson, along with entrepreneur Romain Micol – was the prestigious winner Thursday of the MilliporeSigma Advance Biotech…

From flu jabs, to mAbs, to COVID collabs: BioNTech nabs Novartis plant and labs

BioNTech is buying Novartis’ facility in Marburg, Germany to support the manufacture of its mRNA vaccine candidate against COVID-19. Financial details of the acquisition have not been divulged, but the GMP facility in Marburg (about 50 miles north of Frankfurt) will be used to increase manufacturing capacity for BNT162b2, a Phase III messenger RNA (mRNA) vaccine in development with Pfizer against COVID-19. The Novartis facility houses equipment to produce recombinant proteins, and cell and gene therapies – as well as…

Moderna says ‘simple’ mRNA process allowed speedy COVID vaccine scale-up

The cell-free and enzymatic nature of its mRNA technology has allowed Moderna to quickly build a relatively small network capable of supporting commercial manufacture of its COVID-19 vaccine. On Monday, President Trump named Pfizer and J&J as leading the way in bringing a coronavirus vaccine to market. But also speaking Monday, Tal Zaks, chief medical officer at Moderna Therapeutics, believes it will be his firm that will be the first to bring both a vaccine to market and “to deliver…

Vaxart taking COVID-19 tablet vaccine into clinic

Vaxart may not be the first to commercialize a COVID-19 vaccine, but the firm says the ease of administration and stability of its oral tablet could provide a comprehensive and long-term solution to this global pandemic. South San Francisco-based firm Vaxart is developing an oral vaccine – administered by tablet rather than by injection – against COVID-19, caused by the novel coronavirus (SARS-CoV-2). The firm recently announced the US Food and Drug Administration (FDA) has completed its review of an…

Samsung Bio adds another Big Pharma customer with $331m AstraZeneca deal

AstraZeneca will grow its production network into Asia-Pacific through a contract with Korean CDMO Samsung Biologics for large-scale drug substance manufacturing. Anglo-Swedish pharma firm AstraZeneca is teaming with contract development and manufacturing organization (CDMO) Samsung Biologics in a long-term deal worth an initial $330.8 million, though this could rise to $545.6 million. The specific products to be made at Samsung Biologics’ site in Incheon, South Korea have not been disclosed but AstraZeneca has numerous biologics commercially available and a number…

Perfusion confusion? Cytiva launches Xcellerex system to simplify process

The Xcellerex Automated Perfusion System (APS) simplifies processes and reduces risk when intensifying upstream operations, Cytiva says. We speak with Andreas Castan, strategic technology partnerships leader, to find out why. Bioprocess Insider (BPI): How common is cell cultivation using perfusion? Andreas Castan (AC): There are a number of perfusion-based products on the market, especially unstable proteins like coagulation factors (e.g. Factor VIII), but also mAbs (e.g. Infliximab). Some of these have been around for 20 years or more. The use…

Gardasil scale-up unaffected by COVID capacity chase, says Merck

Merck says bringing two plants online to feed demand for its blockbuster Gardasil remains a priority, despite industry’s unparalleled need for vaccine capacity driven by COVID-19 projects. In January 2020, Merck & Co. (known as MSD outside North America) told delegates at the JP Morgan Conference in San Francisco that to keep up with the “incredible demand” for its human papillomavirus (HPV) vaccines Gardasil and Gardasil 9, two new production plants representing an investment of over $1.6 billion would come…

Lilly turns to Amgen to up COVID-19 antibody production

Amgen will provide manufacturing capacity to support scale-up of monoclonal antibody candidates being developed by Eli Lilly against COVID-19. Financial details of the deal have not been divulged but bringing fellow Big Pharma firm Amgen on board will “significantly increase the supply capacity available for Lilly’s potential COVID-19 therapies,” the firms said in a statement. “Increasing the manufacturing capacity for our neutralizing antibodies through this collaboration with Amgen is a crucial next step, and together we hope to be able…

Takeda opens MA manufacturing unit to support cell therapy R&D

The 24,000 square-foot cell therapy manufacturing facility will produce material through to Phase IIb trials, supporting Takeda’s cell therapy ambitions. In 2019, Takeda expanded its presence in the oncology cell therapy space inking a series of deals and establishing an internal translational cell therapy engine. To support this, the firm invested in a cell therapy manufacturing center at its R&D headquarters in Boston, Massachusetts which opened this week. “The R&D cell therapy manufacturing facility will produce cell therapies for clinical…