Mfg News: Sanofi, Moderna & Civica Rx By
A roundup of manufacturing news from, Sanofi, Moderna, and Civica Rx. Highlights below.
* Sanofi Breaks Ground on Vaccine-Manufacturing Facility
* Moderna To Build mRNA Mfg Facility in Kenya
* Civica Rx To Gain $50 M from California Gov’t To Support Insulin Mfg
Sanofi Breaks Ground on Influenza Vaccine-Manufacturing Facility
Sanofi has broken ground on a new formulation and filling facility at Sanofi’s Swiftwater, Pennsylvania, site. The new facility is in partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services, to increase US-based domestic production capabilities for recombinant pandemic influenza vaccines.
The facility will be a two-story building, complete with cGMP formulation, filling, and support areas. The filler will be capable of filling syringes and vials using isolator barrier technology and single-use technology for flexibility.
The facility represents one of three investments in the Sanofi–BARDA partnership, which supports the clinical development of an adjuvanted recombinant pandemic influenza vaccine that uses the same technology as Sanofi’s recombinant quadrivalent influenza vaccine. The contract also expands the Swiftwater site’s capacity to be a Center of Excellence for pandemic preparedness by enhancing vaccine manufacturing and adding both recombinant and adjuvant technologies to current egg-based platform capabilities.
Moderna To Build mRNA Mfg Facility in Kenya
Moderna and the government of Kenya have finalized an agreement to establish an mRNA manufacturing facility in Kenya. This will be Moderna’s first mRNA manufacturing facility in Africa. Under the partnership, Moderna will build an mRNA facility in Kenya to produce up to 500 million doses of vaccines each year. The company expects the new facility to enable drug-substance and drug-product manufacturing for Kenya and the African continent. In addition, this facility will have surge capacity to scale and respond to public health emergencies in Africa and globally.
Civica Rx To Gain $50 M from California Gov’t To Support Insulin Mfg
Civica Rx, a non-profit pharmaceutical company providing generic drugs, including drugs in shortage, has announced it will manufacture insulins for the State of California’s CalRx Biosimilar Insulin Initiative following a $50-million investment from the state of California toward the development, manufacture and distribution of Civica’s insulins.
Civica will produce three insulins, each of which will be available both in vials and prefilled pens under the CalRx label. CalRx insulins manufactured by Civica are expected to have a manufacturer suggested retail price of no more than $30 per 10-mL vial and no more than $55 for a box of five 3-mL pre-filled pens.
The next phase of this partnership is assessing options for the standup of an insulin manufacturing facility in California.
Source: Civica Rx