Manufacturing

Articles

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

WHO Grants Prequalification to GSK’s Malaria Vaccine

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

Deciding Where to Outsource in Biopharma Development and Manufacturing

Julie Vickers is a subject matter expert in Process Engineering at Jacobs. 

Peter Cramer is a subject matter expert in Process Architecture at Jacobs.

Ranna Eardley-Patel is a sustainable manufacturing lead at CEPI.

Oliver Excell is an implementation expert at PA Consulting.

This article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.

Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine Manufacturing 

Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.

Pfizer and Touchlight Enter Patent License Agreement for Use of dbDNA

Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.

Wacker Biotech Expands Germany Site with Construction of New mRNA Competence Center

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses 

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

First Successful Efficacy Study Against Omicron With COVID-19 Vaccine

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

EMA Starts Rolling Review of Adapted COVID-19 Vaccines

Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.

Batavia Biosciences Increases Capacity for Viral Vectors and Vaccine R&D in the Netherlands

The expansion at Seqirus’ Holly Springs, N.C., manufacturing facility will support the formulation and fill/finish of influenza vaccines.

Vaccine Development and Manufacturing