CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Rovi, Eurofins, and SiO2 Materials Science.
Formulation Development/Drug-Product Manufacturing
Rovi To Fill–Finish Moderna’s COVID-19 Vaccine Candidate
Laboratorios Farmacéuticos Rovi, a pan-European pharmaceutical company specializing in the research, development, contract manufacturing and marketing of small molecules and biologics, has formed an agreement with Moderna, a clinical-stage company developing messenger RNA (mRNA) therapeutics and vaccines, for the large-scale, commercial fill–finish manufacturing of mRNA-1273, Moderna’s mRNA vaccine candidate against COVID-19, at Rovi’s facility in Madrid, Spain.
Under the agreement, Rovi will provide vial-filling and packaging capacity by procuring a new production line and equipment for compounding, filling, automatic visual inspection, and labeling to support production of hundreds of millions of doses of Moderna’s vaccine candidate intended in principle to supply markets outside of the US starting in early 2021. Rovi says it will also hire additional staffing required to support manufacturing operations and production.
SiO2 Materials Science To Increase Vial Mfg for COVID Vaccines, Drugs
SiO2 Materials Science, an advanced materials science company, has scaled its manufacturing capacity for production of vials to support 400 million doses of COVID-19 vaccines and therapeutics and plans to increase capacity to support 1.2 billion doses before the end of 2020.
Last month (June 2020), the company announced $143-million in funding from the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense in partnership with the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, to accelerate the production of the company’s primary packaging platform for storing vaccines and therapeutics for SARS-CoV-2, the virus that causes COVID-19.
The company is also investing an additional $160 million to add two additional manufacturing sites to its Auburn, Alabama-based campus.
The company’s technology provides a glass-like barrier onto plastic surfaces to combine the durability and dimensional precision of plastic with the physical and barrier properties of glass. Its containers can be used for syringes, vials, and cartridges.
Source: SiO2 Materials Science
Eurofins Launches Rapid Point-of-Care COVID-19 Test
Eurofins Technologies, a provider of diagnostic technologies for immunoassays and molecular detection methods, has launched CE-IVD-marked rapid point-of-care testing devices to identify a person’s past exposure to SARS-CoV-2, the virus that causes COVID-19, in 10 minutes. Additionally, Eurofins has published methods for early detection of asymptomatic SARS-CoV-2 virus spreaders that does not require human polymerase chain reaction (PCR) clinical testing.
The serology-based, finger-prick tests detect virus antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, according to information from the company. Esurience-IVD marked INgezim COVID-19 CROM dual-recognition immunochromatographic assays determine the presence of total antibodies (IgG, IgA and IgM) specific to SARS-CoV-2 in a single blood, serum, and plasma sample by using nucleoprotein (N protein) as an antigen for detection of virus antibodies. The company says that the N protein is an abundant, early-onset protein of the virus and is highly immunogenic, thereby making it a reliable antigen candidate for the diagnosis of SARS-CoV-2.
In a separate development, following a study involving over 6,300 PCR tests at nine office and industrial locations in Europe and North America, Eurofins say that its Eurofins COVID-19 Sentinel RT-PCR environmental-surfaces tests can contribute to detecting asymptomatic virus spreaders. Eurofins is launching Eurofins COVID-19 Sentinel worldwide. Through a range of testing solutions, including wastewater testing, work-environment-surface testing and worn-mask testing, Eurofins COVID-19 Sentinel provides an early warning of the presence of SARS-CoV-2 among large populations at a given site before the virus spreads too broadly. If positive results are found, employees present in the rooms tested can be isolated and advised to get tested by clinical reverse transcription polymerase chain reaction (RT-PCR) testing.