CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, Baxter Biopharma Solutions, and others.
Biologics Manufacturing
Fujifilm Begins Production of COVID-19 Vaccines at Texas Facility
Fujifilm Diosynth Biotechnologies, a biologics CDMO, and the Texas A&M University System Center for Innovation in Advanced Development & Manufacturing (CIADM) have announced that production has begun in Texas on two different COVID-19 vaccine candidates with support from the US government.
Fujifilm will produce bulk drug substance of NVX‑CoV2373, Novavax’s COVID-19 vaccine candidate, which began Phase III clinical testing in the US and Mexico in December 2020. NVX-CoV2373 is already being manufactured at commercial scale at the company’s plant in Morrisville, North Carolina.
Fujifilm Diosynth Biotechnologies owns and operates three facilities built through the CIADM program. As a subcontractor of the Texas A&M System, the facilities can be made available for emergency government use. In July 2020, the US government reserved capacity at the College Station facility through the end of 2021 through an agreement with the CIADM. To enhance vaccine production, Fujifilm Diosynth Biotechnologies accelerated its planned capacity expansion investments in the facility by several months. The facility has a total of fourteen 2,000-L cell culture trains.
To prepare for mass production of the vaccine candidates, Fujifilm Diosynth Biotechnologies has added about 260 positions since April 2020, doubling its local workforce. The company plans to recruit another 50 positions.
The CIADM contract is 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. Production of these vaccines are to meet the goals of Operation Warp Speed, a US initiative to speed the development and distribution of COVID-19 vaccines and treatments.
Source: Fujifilm Diosynth Biotechnologies
Formulation Development/Drug-Product Manufacturing
Baxter Biopharma, Novavax in Sterile Mfg Pact for COVID-19 Vaccine
Baxter Biopharma Solutions has entered into an agreement with Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, to provide sterile manufacturing services for NVX-CoV2373, Novavax’s COVID-19 vaccine candidate.
The agreement will advance commercial-scale manufacturing for the vaccine’s production and distribution in UK and European markets. Novavax’s COVID-19 vaccine candidate is currently in Phase III trials and has not yet been authorized or approved for use.
Baxter’s manufacturing services for NVX-CoV2373 will take place at its facility in Halle/Westfalen, Germany.
Source: Baxter International
AMRI Included in US Gov’t CDMO Network for COVID-19 Response
Albany Molecular Research, Inc. (AMRI), a contract research, development and manufacturing organization, has announced its Albuquerque, New Mexico facility has been approved for inclusion in the Biomedical Advanced Research and Development Authority (BARDA) contract CDMO network. The network is part of the US government’s efforts to improve preparedness capabilities. BARDA is part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
AMRI’s Albuquerque site includes a large-scale fill–finish facility, which is currently supporting COVID-19 vaccine production. Inclusion in the network recognizes AMRI’s pandemic preparedness, its existing support of COVID-19 vaccine production, experience in government contracting, and its ability to support further BARDA contract work at the Albuquerque facility.
Source: Albany Molecular Research
iosBio, Immunity Bio in Pact for Oral COVID-19 Vaccine Technology
iosBio, a Burgess Hill, UK-based biotechnology company developing vaccines that can be administered orally, has entered into an exclusive worldwide licensing agreement with ImmunityBio, a Culver City, California-based, clinical-stage immunotherapy company, for iosBio’s oral vaccine delivery platform.
Under the licensing agreement, iosBio has granted ImmunityBio exclusive rights to use its OraPro platform technology for the oral delivery of ImmunityBio’s COVID-19 vaccine candidate. iosBio will be eligible to receive royalties on net global sales of the approved oral vaccine.
Pending ImmunityBio’s discussions with the US Food and Drug Administration, the oral vaccine will enter Phase I trials as a prime and boost to subcutaneous vaccinations.
Source: iosBio
General
Thermo Fisher Expands COVID-19 Program For New Strain Research
Thermo Fisher Scientific has extended its SARS-CoV-2 GlobalAccess Sequencing Program to further support global COVID-19 research and surveillance to assist in identifying new strains of the SARS-CoV-2, the virus that causes COVID-19.
The extension of the SARS-CoV-2 GlobalAccess Sequencing Program will provide additional units of the Ion Torrent Genexus System and Ion GeneStudio S5 Series sequencers at a subsidized price. Thermo Fisher’s sequencing technology offers researchers real-time sequencing-data acquisition and easy data sharing across the global scientific community, as suggested by the US Food and Drug Administration and the European Center for Disease Prevention and Control.
Source: Thermo Fisher Scientific
