CDMO, CMO, Supplier Roundup in Supporting COVID-19 ProjectsBy
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Flamma, Lonza, MilliporeSigma, and Grand River Aseptic Manufacturing.
Chemicals/Chemical API Manufacturing
Flamma in Mfg Pact for Gilead’s COVID-19 Drug Remdesivir
Flamma SpA, a CDMO for small-molecule active pharmaceutical ingredients (APIs), has announced an agreement with Gilead Sciences to manufacture Gilead’s antiviral drug, Veklury (remdesivir), for treating COVID-19.
The agreement, which was formed earlier this year, makes Flamma part of the network of manufacturers contributing to the remdesivir supply chain. Flamma is using its sites in Italy and China to provide manufacturing support.
Gilead’s Veklury is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase III clinical trials are evaluating the safety and efficacy of Veklury for the treatment of SARS-CoV-2, the virus that causes COVID-19, in different patient populations, formulations, and in combination with other therapies. The US Food and Drug Administration recently approved Veklury to treat hospitalized patients with COVID-19.
Source: Flamma Group
Lonza in Mfg Pact for AstraZeneca’s COVID-19 Antibody Combination
Lonza has signed an agreement with AstraZeneca to manufacture AZD7442, a combination of two long-acting antibodies (LAABs) for the potential prevention and treatment of COVID-19.
AZD7442 is currently in Phase I clinical studies, and AstraZeneca plans to advance the LAAB combination into Phase III trials in the coming weeks (as reported on October 30, 2020). Lonza will manufacture the drug substance for AZD7442 at Lonza’s facilities in Portsmouth, New Hampshire. Operations are expected to start in the first half of 2021.
MilliporeSigma, Mammoth Biosciences in Pact for SARS-CoV-2 Test
MilliporeSigma has entered into a pact with Mammoth Biosciences, a San Francisco-based developer of a CRISPR-based disease detection platform, for the development, scale-up, and commercial production of Mammoth’s CRISPR-based SARS CoV-2 diagnostic test.
Mammoth’s systems will be compatible with both nasal swab and saliva samples and are targeting approximately 1,500 tests per eight-hour shift. Mammoth Biosciences plans to submit the assay to the US Food and Drug Administration for emergency use authorization later this year (2020).
MilliporeSigma will serve as the contract manufacturer of the Detectr Boost SARS-CoV-2 Reagent Kit, which will use standard, automated liquid-handling equipment to allow rapid processing of patient samples. The production will take place at MilliporeSigma’s Life Science Center in St. Louis, Missouri.
Mammoth recently secured funding from the National Institute of Health’s RADx program to scale its CRISPR-based testing workflow.
Formulation Development/Drug-Product Manufacturing
GRAM Partners with US Gov’t for COVID-19 Drug-Product Mfg
Grand River Aseptic Manufacturing (GRAM), a Grand Rapids, Michigan-based provider of sterile-manufacturing services, has partnered with the US government for manufacturing COVID-19 vaccines or therapeutics.
GRAM’s new 60,000-square-foot facility in Grand Rapids, Michigan, which provides large-scale fill–finish capacity, is one of three pharmaceutical manufacturing facilities of the company. The newest facility was designed to increase GRAM’s large-scale fill and finish capacity with room to expand as demand grows.