Facilities & Capacity Archives - Page 31 of 73 - BioProcess InternationalBioProcess International

Recipharm to supply fill-finish for Moderna’s COVID vaccine

Moderna has collaborated with CDMO Recipharm to support formulation of its COVID-19 vaccine, mRNA-1273. The vaccine was approved for emergency use in the US in December, and today the European Medicines Agency has recommended the vaccine for authorization. Recipharm is set to join Moderna’s network of contract development and manufacturing organizations (CDMOs) to support mRNA-1273, a cell-free COVID-19 vaccine which, based on evidence from clinical trials, is 94.1% effective at protecting people from SARS-CoV-2. The terms of the agreement have…

WuXi to make COVID-19 vaccine at shelved Bayer hemophilia drug plant

by Gareth Macdonald

WuXi Biologics will make components of COVID-19 vaccines and other biologic products at the facility it bought from Bayer. The Chinese CDMO acquired the plant in Wuppertal, Germany last month in a deal valued at around €150 million ($185 million). Bayer had originally planned to use the Wuppertal plant to produce recombinant factor VIII products. However, in November 2018 the firm announced it would not commission the facility. A Bayer spokesman told us “the decision was based on a review…

Plan to make 1.3bn vaccines in 2021 places strain on Pfizer’s production network

by Ben Hargreaves

Pfizer is focusing on building out an inventory of existing products to concentrate on vaccine production in 2021, the firm says. Pfizer and BioNTech’s mRNA-based COVID-19 vaccine was approved by the European Commission on 21 December, joining previous approvals in the US and the UK, as the partners prepare their commercial manufacturing capacity. Pfizer reduced estimates regarding the number of vaccines it would be able to produce in 2020 from 100 million to 50 million in November. For 2021, the…

LucasPye harnessing strategic partners to bring down CDMO costs

by Dan Stanton

Strategic vendor partnership, lean manufacturing, and cloud-based process control systems will help drive down the cost of making biotherapeutics, says Philadelphia-based CDMO LucasPye Bio. Count the number of contract development and manufacturing organizations (CDMOs) in the US capable of making GMP viral vector products and you get seven, according to Tia Lyles-Williams. They are Lonza, Thermo Fisher, Catalent, Emergent, KBI Biopharma, Fujifilm Diosynth Biotechnologies (FDB), and Lyles-Williams’s own company LucasPye Bio. Meanwhile, only the Emergent, KBI, FDB, and LucasPye have…

French biotech sets up exosome plant to deliver proteins and vaccines

by Dan Stanton

Ciloa says its exosomes can ‘deliver’ large molecules and viral proteins to specific organs and is setting up a clinical plant in Montpellier, France. The €1 million ($1.2 million) investment will be used to create an exosome production unit at Ciloa’s site in Montpellier. The facility will be a technological demonstrator that will be the prototype for larger projects of production of customized exosomes, capable of producing around 1,000 doses to support early clinical trials, the firm told us. Exosomes…

Inovio contracts Kaneka for plasmid DNA COVID vaccine

by Millie Nelson

Inovio has partnered with plasmid manufacturer Kaneka Eurogentec to support the production of its COVID-19 vaccine candidate, INO-4800. Kaneka Eurogentec, an affiliate of Kaneka Corporation, will join Inovio’s growing network of contract development and manufacturing organizations (CDMOs) to support INO-4800, a COVID-19 plasmid DNA-based vaccine, set to move into a Phase II/III clinical trial. The biotech has not disclosed the terms of agreement. However, Inovio’s CEO, Joseph Kim, said that “Kaneka Eurogentec will be a crucial member of Inovio’s global manufacturing…

Production begins at vector suite Catalent set up for Passage Bio

by Gareth Macdonald

Catalent has started making viral vectors to support trials of PBGM01, a gene therapy for the rare lysosomal storage disease GM1 being developed by Passage Bio. The US contract development and manufacturing organization (CDMO) set up a dedicated manufacturing suite at for Passage at its facility in Harmans, Maryland in August. Work since then has focused on bringing the suite online and validating it for the production of the AAVhu68 vector. The vector is used to deliver a modified DNA…

BMS hit by FDA 483 with 6 observations at Washington CAR-T plant

by Dan Stanton

The Form 483 is a further blow to the potential approval of Bristol-Myers Squibb’s lymphoma CAR-T candidate liso-cel, made at the Bothell, Washington facility. The form comes after the US Food and Drug Administration (FDA) visited the facility between October 7 and 16 and lists six heavily redacted observations made about manufacturing processes. These include failures in reviewing any unexplained discrepancies and questions around the reliability of Certificates of Analysis (COAs) from third-party vendors; problems with written records of investigations…

MilliporeSigma accelerates $47m expansions on back of COVID surge

by Dan Stanton

MilliporeSigma has expedited planned capacity expansions at sites in Massachusetts and New Hampshire after seeing a surge in demand for bioprocess equipment from coronavirus therapy and vaccine developers. The Jaffray, New Hampshire facility manufactures single-use components and filtration equipment for biopharma manufacturers. Having added 38,500 square feet of production space last year, MilliporeSigma is now moving forward with a $22 million 25,000 square-foot expansion, adding new production lines and equipment. Concurrently in Danvers, Massachusetts, a 65,000 square-foot expansion – representing…

Fareva enhancer: CureVac to use CDMO for COVID vaccine fill/finish

by Dan Stanton

Messenger RNA (mRNA) vaccine developer CureVac has contracted CDMO Fareva for the fill and finish of COVID-19 vaccine candidate. Under terms of the deal – financials of which have not been disclosed – contract development and manufacturing organization (CDMO) Fareva will provide fill and finish capabilities for CureVac’s COVID-19 vaccine candidate, CVnCoV, from facilities in Val-de-Reuil and Pau, both in France. “We are proud to contribute to the fill and finish manufacturing of this innovative vaccine candidate from CureVac,” said…