CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Catalent and Stevanato Group.
Formulation Development-Drug Product Manufacturing
Catalent, Moderna Enter Pact for Fill–Finish of COVID-19 Vaccine
Catalent and Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, have entered into a collaboration for large-scale, commercial fill–finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate, mRNA-1273, at Catalent’s biologics facility in Bloomington, Indiana.
As part of the agreement, Catalent will provide vial filling and packaging capacity as well as additional staffing required for 24 x 7 manufacturing operations at the site to support production of an initial 100 million doses of the vaccine candidate intended to supply the US market starting in the third quarter of 2020. The companies are in discussions to secure fill–finish capacity for continued production of hundreds of millions of additional doses.
Catalent will also provide clinical supply services from its facilities in Philadelphia, Pennsylvania, including packaging and labeling, as well as storage and distribution to support Moderna’s Phase III clinical study for the vaccine candidate.
Catalent’s 875,000-square-foot biologics facility in Bloomington will undertake the vial filling work under barrier isolator technology. Moderna will use the site’s recent packaging expansion to accelerate manufacturing timelines.
Packaging
Stevanato Group, CEPI Enter Pact for Glass Vials for COVID-19 Vaccines
Stevanato Group, a Padua, Italy-based producer of glass parenteral packaging, and the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition that seeks to derail epidemics by speeding up the development of vaccines, have signed an agreement for the supply of 100 million Type 1 borosilicate glass vials to hold up to 2 billion doses of a COVID-19 vaccine, should the vaccine be proven safe and effective.
This supply is part of CEPI’s efforts to speed up the vaccine development timeline through making progress on manufacturing in parallel with the clinical development of COVID-19 candidate vaccines.
The glass vials that CEPI has secured from Stevanato Group will be able to store 20 doses per vial (2 billion doses in total). Besides the provision of these 100 million vials, Stevanato Group says it will also grant “fast-track” access to its glass vial forming lines provided by its company, Spami.
To date (as reported on June 25, 2020), CEPI has worked in coordination with its partners, investing up to $829 million in nine COVID-19 vaccine candidates. CEPI says the ultimate goal is to speed up the vaccine development timeframe to develop a successful vaccine in an accelerated 12–18-month timeframe.
Source: Stevanato Group and the Coalition for Epidemic Preparedness Innovations
