Author Archives: Dan Stanton

WuXi Biologics strikes deal to bring 8,000 L single-use plant to MA

Two years after announcing plans to expand into the US, WuXi Biologics has signed a land deal allowing construction of a $60 million plant in Worcester, Massachusetts. For Chinese contract development and manufacturing organization (CDMO) WuXi Biologics, 2018 was a landmark year, signaling major growth through the announcement of several expansions. Along with several additional single-use biomanufacturing plants in China, the firm set its sites on global expansion, first announcing plans for a 54,000 L plant in Ireland, then a…

Cell and Gene Therapies Get a Reality Check: A Conversation with Anthony Davies of Dark Horse Consulting Group

As founder of cell and gene therapy (CGT) specialist firm Dark Horse Consulting Group in California, Anthony Davies speaks from a quarter century of experience including former positions at Onyx Pharmaceuticals, Syrrx, ZymeQuest, Serologicals, Geron Corporation, Capricor, and 4D Molecular Therapeutics — and he currently serves on the board of directors for TrakCel and the scientific advisory boards for Akron Biotech and BioLife Solutions. In his plenary address at the Phacilitate 2020 Leaders World conference (part of Advanced Therapies Week…

Prefab facilities could feed the need for COVID vaccine capacity, say Univercells and Exyte

Exyte and Univercells Technologies have teamed to develop and construct modular GMP vaccine manufacturing plants that can be deployed in a third of the time of conventional facilities. As vaccines against COVID-19, caused by the SARS-CoV-2 virus, begin to move through the clinic at an unprecedented speed, the question is rising as to how industry can scale-up production. At the heart of this is ensuring capacity is available to produce millions, if not billions, of doses of a potential vaccine.…

MilliporeSigma reports robust Q1 on back of COVID-19

Merck’s MilliporeSigma is the latest to report bioprocess resilience in the face of COVID-19, and like others has even seen an increase in sales and projects. MilliporeSigma, the life sciences division of Germany’s Merck, saw sales of €1.8 billion ($2 billion) in the first quarter of 2020, up 6.5% on the same period last year, fueled in part by its Process Solutions business unit, which saw sales grow organically by 13.2% (another example of double-digit growth in the biopharma equipment…

J&J brings German CDMO Vibalogics on board for COVID vaccine project

Vibalogics will provide clinical trial material for J&J’s COVID-19 vaccine candidate from its site in Cuxhaven, Germany. J&J is also working with Catalent and Emergent. Johnson & Johnson (J&J) began working on a vaccine against COVID-19 in early January once the coronavirus sequence became first available, and at the end of March identified the lead its lead candidate along with two backups. Since then, the firm has worked on ensuring production of clinical and – potentially – commercial supply, with a pledge…

Inhouse manufacturing helping speedy progression of mRNA COVID vaccine, says Moderna

Moderna Therapeutics believes its Norwood, Massachusetts manufacturing plant is a “competitive strategic advantage†in the race to develop and scale-up a vaccine against COVID-19. Moderna released data from a small Phase I study of its candidate mRNA-1273 yesterday. The trial, conducted by the National Institute of Allergy and Infectious Diseases, showed signs that the candidate elicits antibodies at levels comparable to those found in the blood of dozens of patients who have recovered from COVID-19, caused by the novel coronavirus (SARS-CoV-2).…

Takeda warns of failures and bottlenecks in COVID vaccine rush

Takeda says it is looking to partner to enter the COVID-19 vaccine race but warns industry of the difficulties of developing and manufacturing such products. Industry’s response to the coronavirus pandemic has been unprecedented. According to data provided by Pharma Intelligence, there are – as of Friday 15 May – 116 vaccines in development against COVID-19, nine of which are being trialed in humans. But while pharma giant Takeda has welcomed the surge in COVID-19 programs, CEO Christophe Weber has…

Thermo Fisher doubling viral vector capacity with $180m MA plant

Thermo Fisher will bolster its viral vector manufacturing business through the acquisition of a site in Plainville, Massachusetts. Since Thermo Fisher entered the gene therapy space by acquiring contract development and manufacturing organization (CDMO) Brammer Bio in March 2019, the firm has rapidly invested in its capabilities to service the advanced therapy space. This includes an extra $125 million investment in Brammer announced weeks after buying the CDMO, and expansions at sites in Alachua, Florida and Lexington, Massachusetts. The latest…

Charles River: COVID forces closure of donor clinic disrupting HemaCare biz

Charles River says its cell therapy services business HemaCare is susceptible to the impact of COVID-19 and has already had to temporarily close its donor collections clinic. Charles River Laboratories acquired HemaCare for $380 million in December last year, bolstering its cell therapy services business. HemaCare provides human primary cells as well as services used in the discovery, development and commercial production of cell therapies, and provides leukapheresis services for materials used in the manufacture of Novartis’ Kymriah (tisagenlecleucel), Kite’s…

Aragen and Avid team to offer combined development and manufacturing services

The collaboration offers customers an end-to-end service incorporating cell line development from Aragen Bioscience with process development and manufacturing from Avid Bioservices. Contract research organization (CRO) Aragen has teamed with contract development and manufacturing organization (CDMO) Avid to provide biopharma customers a package from early cell line development through to cGMP manufacturing. “Many of our prospect customers are requesting expedited timelines to GLP-Tox pilot batch and cGMP drug substance deliveries for their early stage programs,†an Avid spokesperson told Bioprocess…