Messenger RNAs (mRNAs) represent a fast-emerging class of biotherapeutics. They hold considerable promise, offering new opportunities for targeted treatment and flexible manufacturing, as demonstrated by the rapid development of mRNA-based COVID-19 vaccines. However, the field is still in its infancy, and the clinical potential of mRNA extends beyond vaccines. To date, there have been more than 348 clinical studies involving mRNA as an active ingredient or an enabler for cell and gene therapies such as CRISPR-Cas9 derived therapeutics. Lonza has…
Thursday, June 15, 2023 Daily Archives
Novo Nordisk ploughing $2.3bn into Danish manufacturing network
Novo Nordisk will expand its site in Hillerød, Denmark to create additional production capacity to meet future demands for its late-phase chronic diseases products. The DKK 15.9 billion ($2.3 billion) expansion in Hillerød is expected to facilitate the production of active pharmaceutical ingredients (APIs) and contribute to Novo Nordisk’s future clinical product portfolio. The new facility will span 65,000 square meters and will be designed as a flexible multi-product facility. It will prioritize an efficient and environmentally sustainable working environment…
‘No surprises:’ AGC promising fixed timelines for mAbs and more
AGC Biologics has launched its AGCellerate program, which it says will advance biologics projects with guaranteed fixed timelines and costs. Contract development and manufacturing organization (CDMO) AGC said AGCellerate has been designed to deliver IND-ready GMP material for biopharmaceutical players. The monoclonal antibody (mAb) program is available, and the firm expects to release further details on other modalities later this year. “By giving biotherapeutic developers one standard platform built to address standard mAb needs in the industry AGCellerate guarantees 1…
Croda breaks ground on PA lipid plant
The facility in Lamar, Pennsylvania will be used to manufacture lipid nanoparticles used to support mRNA vaccines and gene-edited therapeutics, says Croda. In mRNA and drug manufacturing, lipids are used to deliver mRNA vaccines and gene editing therapies, stabilize and protect drugs, and improve the solubility of drugs. According to Croda, the firm was integral in scaling-up and providing lipids to support mRNA vaccines for COVID-19 and since then “there has been an explosion of mRNA and gene editing projects…