CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Grand River Aseptic Manufacturing, Quotient Sciences, and Pall Corporation.
Formulation Development/Drug-Product Manufacturing
Grand River Aseptic Manufacturing in US Gov’t Mfg Contract for COVID-19
Grand River Aseptic Manufacturing (GRAM), a Grand Rapids, Michigan-based provider of sterile-manufacturing services, has been selected by the US Department of Health and Human Services (HHS) and the US Department of Defense (DoD) to support the expansion of the US’ capacity for manufacturing and distributing vaccines or therapeutics related to the COVID-19 pandemic.
Through this public–private partnership, the US government is reserving fill–finish capacity on a commercial filling line for use by federal partners that are developing COVID-19 vaccines or therapeutic treatments. GRAM’s capacity supports the US government’s Operation Warp Speed, a US government initiative to accelerate the development of vaccines and treatments against COVID-19, but also increases US preparedness for future public health emergencies.
The contract was awarded as a collaboration between the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), and the Army Contracting Command.
GRAM will use its new 60,000-square-foot large-scale fill–finish facility located in Grand Rapids, Michigan to support the effort. In total, the CDMO has three manufacturing facilities and more than 100,000 square feet of production space. GRAM’s large-scale fill–finish facility was designed for growth and contains additional space to add more equipment and fill suites as demand continues.
Source: Grand River Aseptic Manufacturing
Quotient Sciences, Ana Therapeutics, Partner for COVID Drug Candidate
Ana Therapeutics, a Foster City, California-based biopharmaceutical company, and Quotient Sciences, a CDMO, have formed a partnership to support the manufacturing of ANA Therapeutics’ drug candidate, ANA001 (niclosamide capsules), which Ana is developing as a potential treatment for COVID-19. As part of the collaboration, Quotient will scale up the capsule formulation, characterize, and optimize the manufacturing process and ensure continuity of drug product through clinical trials. The drug is FDA-approved for treating tapeworm.
Under the agreement, ANA Therapeutics will access Quotient’s formulation and manufacturing expertise to develop and supply drug product for clinical trials in the third quarter of 2020. The program will be conducted at Quotient’s facility in Garnet Valley, Pennsylvania.
Source: Quotient Sciences
General
Pall Awarded $4.9-M US Gov’t Contract To Build Ventilator Filter Mfg Line
Pall Corporation, a provider of filtration, separation, and purification products and services, has been selected by the US Department of Defense (DoD) to receive a $4.9-million contract to build a new breathing filter manufacturing line within an existing US-based Pall manufacturing facility to increase ventilator filter production.
Set to open in fall 2021, Pall’s ventilator filter production capacity will increase from 485,000 units per month to 650,000 units per month to meet demand in the US for ventilator filters driven by COVID-19.
The grant is the result of a partnership between the DoD and the US Department of Health and Human Services (HHS) to determine how to increase domestic ventilator critical component suppliers’ capacity.
Source: Pall Corporation
