CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Catalent, Emergent BioSolutions, AGC Biologics, Cobra Biologics, Jacobs Engineering, and Cascade Chemistry.
Chemical/Chemical API Manufacturing
Cascade Chemistry To Produce API for COVID-19 Antiviral Drug
Cascade Chemistry, a Eugene, Oregon-based contract research and manufacturing organization, has been selected to produce the active pharmaceutical ingredient (API) for clinical trial supplies of RBT-9, an investigational therapy entering a Phase II trial for treating COVID-19, which is being developed by Renibus Therapeutics, a Lantana, Texas-based pharmaceutical company. The drug has been awarded fast-track designation by the US Food and Drug Administration.
Source: Cascade Chemistry
Biologics Manufacturing
Emergent, AstraZeneca in $87-M Mfg Deal for COVID-19 Vaccine
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, has entered into an $87-million deal with AstraZeneca for CDMO services to support manufacturing of AstraZeneca’s vaccine candidate for COVID-19, AZD1222, a viral vector-based, weakened version of adenovirus containing the genetic material of the SARS-CoV-2 spike protein, being developed by Oxford University.
Under the agreement, Emergent will provide development services, technology transfer, analytical testing, and drug-substance process and performance qualification and will reserve certain large-scale manufacturing capacity through 2020. AstraZeneca’s AZD1222 is one of several candidates supported by Operation Warp Speed, a US government program to accelerate the development, manufacturing, and distribution of COVID-19 medical countermeasures by January 2021.
Development services will be provided out of Emergent’s Gaithersburg product-development facility. Large-scale manufacturing of drug substance will be done at the company’s Baltimore Bayview facility, a US Department of Health and Human Services-designated Center for Innovation in Advanced Development and Manufacturing. The Bayview facility has four suites for clinical-scale production to enable large-scale manufacturing to up to 4,000 L. The facility has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis based upon the platform technology being used.
Source: Emergent BioSolutions
Cobra Biologics, AstraZeneca Form Mfg Pact for COVID-19 Vaccine
Cobra Biologics, a biologics CDMO, has signed a supply agreement with AstraZeneca to provide GMP manufacture of AstraZeneca’s adenovirus vector-based COVID-19 vaccine candidate, AZD1222.
The production agreement is part of AstraZeneca’s recently announced in-licensed program with the University of Oxford to ensure broad and equitable supply of the vaccine at no profit during the COVID-19 pandemic.
Earlier this year (March 2020), Cobra announced that it is part of a consortium with the Jenner Institute at the University of Oxford, and others to develop, scale up, and produce the vaccine.
Cobra is providing AstraZeneca and other manufacturing organizations large-scale manufacturing capacity for the AZD1222 vaccine. Cobra, along with other consortium members, will be manufacturing the vaccine with first deliveries to begin in the UK in September 2020.
Source: Cobra Biologics
AGC Biologics, Saiba Form Mfg Pact for COVID-19 Vaccine
AGC Biologics, a biologics CDMO, is partnering with Saiba AG, a Pfäffikon, Switzerland-based biopharmaceutical companies specializing in virus-like particle (VLP) vaccines for infectious and chronic diseases, to manufacture a SARS-CoV-2 vaccine to protect against COVID-19.
Source: AGC Biologics and Saiba AG
Formulation/Drug Product Manufacturing
Catalent To Provide Fill-Finish, Pkg for AstraZeneca’s COVID-19 Vaccine
Catalent Biologics will provide vial filling and packaging capacity and prepare for large-scale commercial supply for AstraZeneca’s/University of Oxford’s adenovirus vector based COVID-19 vaccine candidate, AZD1222. The recombinant adenovirus vaccine technology was created by the Jenner Institute at the University of Oxford, and the vaccine candidate is currently in clinical trials.
The agreement accelerates the scale-up of capacity over the coming months (as announced on June 15, 2020) to support the dedicated production of AZD1222. Catalent will prepare its facility in Anagni, Italy to enable manufacturing and supply hundreds of millions of doses of the vaccine candidate from August 2020 and potentially through to March 2022, should the product be approved by regulatory agencies.
Catalent’s 305,000-square-foot facility in Anagni has capabilities in aseptic liquid filling for biologics and sterile products across multiple vial sizes and also provides primary and secondary packaging, including serialization, to support product launches for oral solids, sterile, and biologics products.
Source: Catalent
Jacobs To Retrofit AstraZeneca’s Mfg Facility for COVID-19 Vaccine
Jacobs Engineering Group was selected to provide engineering, procurement, construction management, and commissioning/qualification/validation to retrofit AstraZeneca’s West Chester, Ohio manufacturing facility to deliver a potential vaccine to address COVID-19.
Jacobs’ work includes upgrading an existing idle fill line to support formulation, vial filling, visual inspection, and packaging of the COVID-19 vaccine at the earliest date possible in the fall of 2020.
Source: Jacobs Engineering
