Facilities & Capacity Archives - Page 41 of 73 - BioProcess InternationalBioProcess International

In brief: GSK inks $231m ‘flexible’ deal with Samsung BioLogics

GSK says the eight-year agreement with the Korean CDMO brings additional and flexible capacity to manufacture its innovative biopharmaceutical therapies. UK-headquartered pharma giant GlaxoSmithKline (GSK) has an extensive manufacturing network to support its biologics product portfolio but has turned to contract development and manufacturing organization (CDMO) Samsung BioLogics to secure capacity for future needs. The deal will see Samsung Biologics provide GSK with additional capacity for large-scale biomanufacturing from its site in Incheon, South Korea. The capacity will be flexible…

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

by Dan Stanton

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…

AZ aims to ship Oxford’s COVID vaccine from September using BARDA’s $1bn

by Gareth Macdonald

AstraZeneca says $1 billion from the US Biomedical Advanced Research and Development Authority (BARDA) will fund production of Oxford University’s SARS-CoV-2 vaccine. The Anglo-Swedish drug firm said it would begin production of the vaccine candidate – previously known as ChAdOx1 nCoV-19 and now called AZD1222 – in the autumn. It added that the BARDA funding will also support a support a Phase III trial involving 30,000 participants and a pediatric study. AstraZeneca set the funding as part of an effort to…

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

by Dan Stanton

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.…

Rapid Micro Biosystems to fund EU facility construction with $120m fundraising

by Gareth Macdonald

US sterility testing tech firm Rapid Micro Biosystems will build a European plant and expand its business with $120 million raised this week. The Lowell, Massachusetts firm – which makes automated microbial detection systems – completed a $120 million financing round this week, attracting equity investment from The Ally Bridge Group, Endeavour Vision, and existing investors including Asahi Kasei. CEO Robert Spignesi told Bioprocess Insider the firm’s “growth plan includes establishing new manufacturing capacity, beyond our current US manufacturing facility…

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

by Dan Stanton

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

by Dan Stanton

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).…

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

by Dan Stanton

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…

Orchard halts plant construction in shift away from ultra-rare diseases

by Gareth Macdonald

Orchard Therapeutics has ceased work on a manufacturing plant in Fremont, California, reduced investment in some therapeutic programmes and cut its workforce by 25%. The gene therapy firm announced the changes last week as part of a strategic plan to shift focus from ultra-rare diseases to more common conditions. According to a document filed with the US Securities and Exchange Commission, Orchard plans to rely on contract development and manufacturing organizations (CDMOs) while it assesses potential development of in-house manufacturing…

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

by Dan Stanton

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…