Author Archives: Dan Stanton

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…

Pfizer brings aseptic Michigan site into COVID-19 vaccine production mix

Pfizer’s sterile injectable facility in Portage, Kalamazoo is among the sites being leveraged to support clinical trials of a COVID-19 vaccine being developed with BioNTech. In April, Pfizer teamed up with German firm BioNTech on its messenger (RNA) vaccine program against COVID-19, caused by the novel coronavirus (SARS-CoV-2). A month on, and the candidate BNT162 has entered the clinic with the first US patients being dosed in a Phase I/II trial this week. To support rapid development, Pfizer has stressed…

Regeneron clears capacity at NY plant in prep for COVID antibody cocktail

Regeneron says depending on trial data it could be producing hundreds of thousands of doses of an antibody cocktail against COVID-19 by the end of summer. Regeneron was one of the first to announce its intentions to develop monoclonal antibodies (MAbs) against COVID-19, caused by the novel coronavirus (SARS-CoV-2). Using its VelociSuite discovery and development technologies and experience garnered to develop its investigational triple antibody cocktail treatment for Ebola REGN-EB3, the firm has is focused on developing a multi-antibody ‘cocktail’…

Univercells on balancing its bioprocess tech and CDMO subsidiaries

Univercells has launched a bioprocess technology subsidiary it says can offer a new generation of biomanufacturing platforms that can solve industry’s manufacturing challenges. It has been a busy few months for Belgium-based biologics platform firm Univercells. In February, global investment firm KKR – through its portfolio of life sciences tools companies Gamma Biosciences – committed €50 million ($54 million) into the firm Univercells. Then last month, the firm launched Exothera, a process development and viral vector contract development and manufacturing…

With Arcturus mRNA, Catalent bags another COVID vaccine project

Catalent will make scaled-up batches of Arcturus Therapeutics’ mRNA vaccine candidate from a customized suite at its Madison, Wisconsin facility. The CDMO says it has been presented with around 100 opportunities to support COVID-19 development projects. Under terms of the deal, financials of which have not been divulged, contract development and manufacturing organization (CDMO) Catalent will make Arcturus’ COVID-19 messenger RNA (mRNA) vaccine candidate LUNAR-COV19 to support clinical trials. The potential single-shot vaccine uses Arcturus’ STARR Technology platform, which combines…