Vaccine Development and Manufacturing

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.

Contract manufacturers play a key role in the production of lipid nanoparticles for RNA vaccines.

Expected to be completed by 2022, the new addition is part of the Samsung Biologics’ long-term strategy to become a fully integrated global biopharmaceutical company.

Bio/pharmaceutical manufacturers have made a good first step toward global vaccination through pledging doses at no- to low-profit rates.

In the face of a growing clamor for greater worldwide access to COVID-19 vaccines, biopharma companies are promising to expand distribution of free and low-cost preventives to curb the pandemic globally.

Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.

Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.

In the study, which enrolled 3700 US participants ages 12 to less than 18 years, no cases of COVID-19 were found in participants who had received two doses of the Moderna COVID-19 vaccine.

Samsung Biologics plans to support the production of hundreds of millions of doses of Moderna’s vaccine to supply to markets outside of the United States beginning in the third quarter of 2021.

Pfizer and BioNTech have entered into a new agreement with the European Commission to supply 900 million doses of Comirnaty to the European Union with an option to request up to 900 million additional doses.

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Originally established in the 1970s as a fetal bovine serum supplier, Fujifilm Irvine Scientific continuously proved its strength in the cell culture solutions space.

Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.

BioNTech plans to expand its global footprint by establishing its regional headquarters for southeast Asia and a new mRNA manufacturing facility in Singapore.

Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.

Moderna will double the space at its Moderna Technology Center in Norwood, MA, to transform it from a production and lab space into an industrial technology center.

Moderna has entered into an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of its COVID-19 vaccine to the 92 Gavi COVAX Advance Market Commitment low- and middle-income countries.

Under the terms of the contract, Meissner will expand its Camarillo, Calif., manufacturing site by adding additional cleanroom manufacturing space, executing advanced inventory management systems, and adding support areas to supplement capacity.

Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.

As face masks start to come off, bio/pharma’s COVID-19 battle goes on.

Moderna’s investments will double the formulation fill/finish and drug substance manufacturing of its vaccine to up to three billion doses in 2022 at various manufacturing sites.

Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe.