CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Cytiva, Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, LabVantage.
Biologics Manufacturing
Cytiva in $31-M US Gov’t Pact for Consumables for COVID Vaccines
Cytiva, a provider of products and services to the life-sciences industry, has been awarded $31 million by the US government to expand the company’s manufacturing capacity for vaccine-related consumable products to support Operation Warp Speed, a US government initiative to accelerate the development and manufacture of vaccines and therapeutics against COVID-19.
The agreement is for vaccine-related consumables, such as liquid and dry-powder cell-culture media, cell-culture buffers, mixer bags, and XDR bioreactors. Under the agreement, the company will expand manufacturing capacity in its Massachusetts facilities and create duplicate capabilities in Cytiva’s Utah facilities to be complete in less than 12 months. Currently, the company only manufactures consumables in its facilities in Massachusetts.
The agreement is with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and the Joint Program Executive Office at the Department of Defense.
Source: Cytiva and US Department of Health and Human Services
Fujifilm To Manufacture Lilly’s COVID-19 Therapeutic Antibody
Fujifilm Diosynth Biotechnologies, a biologics CDMO, reports it will manufacture COVID-19 therapeutic antibody of Eli Lilly and Company at its facility in Hillerød, Denmark.
The commercial manufacturing falls under an agreement between Lilly and the Bill & Melinda Gates Foundation as part of the COVID-19 Therapeutics Accelerator, an initiative launched by the Gates Foundation, Wellcome, and Mastercard to speed the development of and access to therapies for COVID-19.
Earlier this year, Fujifilm Diosynth Biotechnologies announced that it had reserved manufacturing capacity for the COVID-19 Therapeutics Accelerator at its large-scale biologics production facility in Hillerød. Commercial manufacturing of the Lilly antibody therapy is expected to commence in April 2021.
Fujifilm Diosynth Biotechnologies’ Hillerød cGMP facility is equipped with 6 x 20,000L bioreactors for the manufacture of cell-culture-derived biologics for clinical and commercial use. The company recently announced an investment of $928 million to double capacity at the facility and add drug- product filling capabilities. This agreement accounts for part of the production capacity in this facility, which also produces other biologic products.
Source: Fujifilm Diosynth Biotechnologies
General
LabVantage Gets US Gov’t Contract for LIMS for COVID Vaccines
LabVantage Solutions, a provider of laboratory informatics products and services, including laboratory information management systems, has been awarded a contract by the US Army Medical Research Acquisition Activity to supply its LabVantage Pharma laboratory information management system (LIMS) to the Walter Reed Army Institute of Research (WRAIR).
WRAIR will use LabVantage Pharma to support vaccine production programs for COVID-19 and other diseases at its pilot bioproduction facility in Silver Spring, Maryland.
Source: LabVantage Solutions
Thermo Fisher Expands with New COVID-19 Antibody Tests
Thermo Fisher Scientific has expanded its COVID-19 test portfolio with the introduction of two new SARS-CoV-2 antibody tests.
The first test, the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test, developed in conjunction with the Mayo Clinic and WuXi Diagnostics, has been granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M (IgM), immunoglobulin A (IgA) and immunoglobulin G (IgG).
The second test, the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test, is commercially available in accordance with the FDA’s “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).” The EUA is currently under review by the FDA.
These tests are now available in Europe and countries accepting the CE Mark, which indicates conformity to standards for products sold within the European Economic Area.
Source: Thermo Fisher Scientific
