Corden Expands Pact with Moderna
German Contract Development & Manufacturing Organization CordenPharma has expanded its strategic manufacturing services agreement with Moderna to include the supply of lipid excipients for the US biotech’s mRNA-1273 Covid-19 vaccine candidate.
CordenPharma Switzerland originally signed the manufacturing pact with Moderna in 2016. The amended agreement, which takes effect immediately, now includes CordenPharma Chenôve in France and CordenPharma Colorado in the US.
The new terms call for production of larger-scale volumes of lipids, while continuing to draw upon CordenPharma Switzerland’s position as a leader in specialized lipid manufacturing, the company said.
CordenPharma is the global pharmaceutical manufacturing platform of the International Chemicals Investor Group (ICIG), a full-service CDMO for APIs, drug products and packaging.
The company’s cMP facilities across Europe and the US are organized are under four Technology Platforms – Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology and Small Molecules.
Moderna has now begun Phase 2 studies with its vaccine candidate, in which it will evaluate the safety, reactogenicity and immunogenicity of two vaccinations given 28 days apart.
Altogether 600 people are expected to take part in the study, divided evenly into two age groups, of 18 and 55 years old and people over the 55 respectively. Both groups will be tracked over 12 months. Last month, the US Food and Drug Administration (FDA) granted mRNA-1273 "fast track" designation.
The US biotech expects to collaborate with the US National Institute of Allergy and Infectious Diseases (NIAID) on a Phase 3 study by July. Moderna and NIAID also collaborated on Phase 1, which is being prepared for peer review.