CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Almac, Samsung Biologics, and Cytiva.
Chemicals/Chemical API Manufacturing
Almac Gets $500,000 Grant for Mfg of COVID-19 Drug Remdesivir
Almac Sciences, a member of the Almac Group, a Craigavon, UK-based CDMO, has been awarded a grant of approximately $500,000 by the COVID-19 Therapeutics Accelerator, a philanthropic collaboration, for the production of remdesivir, the active pharmaceutical ingredient in Gilead Science’s antiviral drug, Veklury, approved to treat COVID-19.
Remdesivir is the first drug to be approved by the US Food and Drug Administration as a treatment for COVID-19 after a trial showed it cut recovery time by five days. The grant supports the process development and manufacturing of remdesivir.Almac Sciences has devised a plan to improve the overall route of synthesis to remdesivir, including application of synthetic flow methodology and biocatalysis.
The COVID-19 Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, with funding from public and philanthropic donors to speed up the response to the COVID-19 pandemic by funding the identification, assessment, development and scale-up of treatments.
Source: Almac Group
Biologics Manufacturing
Samsung Biologics, Lilly in Mfg Pact for COVID-19 Antibody Treatments
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, has entered into a long-term manufacturing agreement with Eli Lilly and Company for the supply of Lilly’s COVID-19 antibody therapies.
Lilly and Samsung Biologics entered into the manufacturing partnership agreement in May (May 2020). Samsung says it manufactured and delivered an initial supply of active pharmaceutical ingredients within five months of signing the contract. Additionally, the company says the timeline for technology transfer was reduced to less than three months, due to coordination between technical, quality, supply chain, and regulatory experts from both companies.
Source: Samsung Biologics
Cytiva To Scale Up Output of Clover’s COVID-19 Vaccine
Cytiva, the new name of GE Healthcare Life Sciences following Danaher’s $21.4-billion acquisition of GE Healthcare Life Sciences in April 2020, has announced it is supporting Clover Biopharmaceuticals, a Chengdu, China-based biopharmaceutical company, to accelerate the development and manufacturing of Clover’s COVID-19 vaccine candidate.
With promising preliminary results from a Phase I clinical study of its protein-based S-Trimer subunit vaccine candidate, Clover will expand its current 2 x 2,000-L capacity of the Cytiva FlexFactory, which went into service in January (January 2020). The Cytiva FlexFactory includes process equipment, services, and consumables to scale up capacity for vaccine development and manufacturing. Cytiva will help Clover add two more 2,000-L bioreactors for a total of 4 x 2,000-L manufacturing capacity through the Cytiva FlexFactory.
Clover’s Phase I clinical study has completed enrollment of 150 adult and elderly participants. Based on positive preliminary results, an additional 280 participants will be enrolled in a Phase I dose-expansion study at a selected S-Trimer dose-level. The company intends to initiate a global Phase II/III vaccine efficacy study before the end of 2020.
Source: Cytiva Life Sciences
