CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring BD, Fujifilm Diosynth, IDT Biologika, Dalton Pharma, Sterling Pharma, and Argonaut.
Chemicals/Chemical API Manufacturing
Sterling Pharma To Provide Mfg for Moleculin Biotech’s COVID-19 Drug Candidate
Sterling Pharma Solutions, a Dudley, UK-headquartered CDMO of small-molecule active pharmaceutical ingredients (APIs), has signed an agreement with Moleculin Biotech, a Houston, Texas-based clinical-stage pharmaceutical company, to support Moleculin’s preparation for an investigational new drug application (IND) to the US Food and Drug Administration for Moleculin’s investigational COVID-19 treatment, WP1122.
Moleculin is planning preclinical studies for the IND, including testing multiple analogs of WP1122 against various viruses in vitro, and potentially, in vivo. Sterling will support final purification of WP1122 at its site in Cary, North Carolina and help ensure a supply of the drug for preclinical studies and expected clinical trials.
Source: Sterling Pharma Solutions and Moleculin
Biologics Manufacturing
Fujifilm Initiates Mfg of Novavax’ COVID-19 Vaccine Candidate
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, and Fujifilm Diosynth Biotechnologies, a biologics CDMO, have entered an agreement under which Fujifilm Diosynth will manufacture bulk drug substance for NVX-CoV2373, Novavax’s COVID-19 vaccine candidate.
The first batch of NVX-CoV2373 has begun at Fujifilm’s site in Morrisville, North Carolina. This arrangement falls under Novavax’s recent $1.6-billion award by the US government as part of Operation Warp Speed, a US government program that aims to accelerate development of COVID-19 vaccines and treatments. The funding is being used by Novavax to: (1) complete late-stage clinical development, including a Phase III clinical trial; (2) establish large-scale manufacturing; and (3) deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020.
NVX‑CoV2373 consists of a stable, prefusion protein made using the company’s proprietary nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate neutralizing antibodies. The batches produced at Fujifilm Diosynth’s site in North Carolina will be used in a future Phase III clinical trial of up to 30,000 subjects that is expected to begin in the fall of 2020.
Preliminary immunogenicity and safety results of a Phase I/II clinical trial of NVX-CoV2373 are expected at the end of July (July 2020), and the Phase II portion to assess immunity, safety, and COVID-19-disease reduction is expected to begin thereafter. The Phase I/II clinical trial is being supported by a funding arrangement worth up to $388 million from the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases.
In a separate development, Fujifilm Diosynth has been subcontracted by Texas A&M University to provide manufacturing from the company’s biomanufacturing facility in College Station, Texas as part of the university’s $265-million task order from the US government for manufacturing of COVID-19 vaccines. See related story.
Source: Novavax and Fujifilm Diosynth Biotechnologies
Formulation Development/Drug-Product Manufacturing
IDT Biologika Fills Batch of COVID-19 Vaccine Candidate
IDT Biologika has filled a second clinical batch of a vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, at its facility in Dessau, Germany.
The vaccine is being developed by the German Center for Infection Research with its partners, IDT Biologika, Ludwig Maximilian University of Munich (LMU Munich), Marburg University, and the University Medical Center Hamburg-Eppendorf (UKE Hamburg), the teaching hospital of the University of Hamburg. IDT Biologika developed a cell line and a procedure that enabled the large-scale production of an ultrapure MVA (modified vaccinia Ankara) vector vaccine, and LMU Munich produced stable MVA vectors. Approximately 1,000 individual vaccine doses are being prepared for a Phase I study to be conducted at UKE Hamburg.
Source: IDT Biologika
Dalton Pharma Services To Provide Formulation, Fill–Finish for COVID Vaccine
Dalton Pharma Services, a CDMO of active ingredients and drug products, has entered into a partnership with the University of Saskatchewan’s Vaccine and Infectious Disease Organization–International Vaccine Center (VIDO-InterVac) to provide formulation and fill–finish services for early-phase clinical trials for VIDO-InterVac’s innovative COVID-19 vaccine candidate.
Dalton will provide the services from its facility in Toronto, Canada. VIDO-InterVac hopes to initiate clinical trials of its vaccine in the fourth quarter of 2020.
Earlier this year (April 2020), the Canadian federal government announced a $1.1-billion plan to support COVID-19 vaccine research and clinical trials. VIDO-InterVac has received funding from both the Canadian federal government and the government of Saskatchewan.
Source: Dalton Pharma Services
Argonaut Expands Capacity for Viral Transport Media Filling for COVID-19 Testing
Argonaut Manufacturing Services, a Carlsbad, California-based CDMO, has completed an expansion of its viral transport media (VTM) filling capacity to meet increased demand from COVID-19 testing.
The company notes that guidelines by the US Centers for Disease Control and Prevention specify sample swabs should be immediately stored in VTM or similar media.
Source: Argonaut Manufacturing Services
Packaging
BD Gets Orders for Additional 177 M Injection Devices for COVID-19 Vaccines
Becton, Dickinson and Company (BD), a Franklin Lakes, New Jersey-based medical technology company, reports additional orders from the US and Canada of 177 million injection devices (needles and syringes) in response to COVID-19.
The new US order for 140 million injection devices brings total US orders from BD to 190 million devices. The new Canadian order for 37 million brings total Canadian orders from BD to 75 million devices. Globally, BD has received total orders of 330 million needles and syringes from the US, Canada, and the UK. A majority of these orders will be delivered by the end of December 2020 in anticipation of a vaccine being approved late this year or early 2021. BD says it continues to be in discussions with governments globally on the need to place orders immediately for early 2021 delivery.
Earlier this month (July 2020), BD announced a $70-million investment to expand needle and syringe production at its facilities in Nebraska as part of a partnership with the Biomedical Advanced Research and Development Authority, part of Office of the Assistant Secretary for Preparedness and Response at the US Health and Human Services, and the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to develop new manufacturing lines for injection devices that will provide priority access to the US government for hundreds of millions of syringes and needles to support current and future pandemic vaccination efforts. As part of the partnership, BARDA with JPEO-CBRND is providing an estimated $42 million into the $70-million capital project. The new capacity is expected to be on line within 12 months (as reported on July 21, 2020).
Source: BD
