CDMO, CMO, Supplier Roundup in Supporting COVID-19 ProjectsBy
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Wacker, Recipharm, and ApiJect.
CureVac, Wacker in Mfg Pact for COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics, and Wacker, a Munich, Germany-based chemical company and CDMO of biologics, have signed a contract for the manufacturing of CureVac’s COVID-19 vaccine candidate, CVnCoV.
Under the agreement, Wacker will ramp up production of the mRNA drug substance for CVnCoV at its biomanufacturing site in Amsterdam in the first half of 2021. The companies say preparations for the start of production, technology transfers, and test runs are already underway, with plans to produce more than 100 million doses of the vaccine per year at Wacker’s Amsterdam site. The companies say there is also future potential for expansion at the site.
CureVac is building an integrated European vaccine manufacturing network with several CDMO partners. With this strategy, the company says it will increase manufacturing capacity internally within CureVac for CVnCoV up to several hundred million doses per year and will work with several partners for key manufacturing process steps.
Formulation Development/Drug-Product Manufacturing
Recipharm To Provide Fill–Finish for Moderna’s COVID-19 Vaccine
Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has signed a letter of intent with Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, to formulate and fill–finish Moderna’s COVID-19 vaccine candidate, mRNA-1273.
The activity will be performed in Recipharm’s drug-product manufacturing facility in Monts, France. Recipharm has reserved capacity to support the anticipated demand for the vaccine and says it is already in the process of recruiting additional staff and making certain investments to enable technology transfer and scale-up.
ApiJect Gets $590-M Gov’t Loan for Mfg Facility for COVID-19 Products
ApiJect Systems, a Stamford, Connecticut-based provider of prefilled syringes, has been approved by the US government for a $590-million loan to construct a multi-facility campus to package high volumes of injectable medicines and vaccines, including products for treating COVID-19.
The loan from the US International Development Finance Corporation (DFC) will allow the company to expand in Research Triangle Park, North Carolina with a one million-square-foot campus that will include a fill–finish facility with capacity to produce up to 3 billion single-dose prefilled injectors annually. The new facility brings together blow-fill-seal (BFS) technology with ApiJect’s proprietary pen needle-style hubs to package drugs in BFS prefilled pharmaceutical-grade plastic injectors. The facility with house 15 production lines to fill–finish vaccines and therapeutics. Each manufacturing line will be isolated to allow for up to 15 different drugs to be packaged simultaneously. In addition to its BFS production lines, the ApiJect campus will house two separate special-purpose drug manufacturing facilities to handle drugs, such as antibiotics and cytotoxic drugs, and an onsite needle and cannula factory. The facility would be able to handle vaccines requiring standard cold storage as well as those in need of ultra-cold storage down to -70 degrees Celsius.
The DFC loan will be for 10 years, at an interest rate of approximately 4.5%. Closing of the DFC loan is conditioned on DFC’s completion of due diligence and finalization of financing arrangements. Under the loan’s terms, an additional $195 million of equity to complete the overall campus must come from non-US government sources.
This loan complements ApiJect’s previous $138-million contract with the US Department of Defense and the Department of Health and Human Services to scale up its injector production under Operation Warp Speed, an US government initiative to speed the development and delivery of COVID-19 vaccines and treatments. Under that project, ApiJect partnered with The Ritedose Corporation (TRC), a Columbia, South Carolina-based company that manufactures sterile products for hospitals and healthcare facilities, to repurpose and upgrade a TRC facility to support fill–finish capacity for up to 45 million drug or vaccine doses per month.