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Overview
The Vaccine Clinical Materials Program conducts the tech transfer, manufacture, and supply of early phase clinical materials for use in investigational studies targeting infectious diseases of global significance.
We are a team of highly trained scientists, technicians and professionals that operate a pilot plant engaged in the production, testing, release and supply of Phase I/II clinical materials for first-in-human studies. Our facility upholds Current Good Manufacturing Practice (CGMP) regulations in its operations.
We produce high-quality, sterile, vialed drug products and provide content input. Disease targets and associated products we work on include:
- HIV
- MAbs
- Glycoprotein trimer vaccines
- Peptide conjugate vaccines
- Influenza
- Multi-valent nanoparticle vaccines
- Malaria
- mAbs
- Adjuvants
All production is done by fermentation and/or mammalian cell culture in 50 -2000 liter bioreactors.
We conduct analytical stability on all our products, distribute clinical products in the U.S. and internationally, and manage all product inventory on behalf of the Vaccine Research Center in the National Institute of Allergy and Infectious Diseases. We procure services and supplies for the Vaccine Research Center to support early research and development, enable external transfer of processes and methods to licensees, and facilitate pre-clinical work under subcontracts at several universities and companies.
Our products have been administered to thousands of patient volunteers in U.S. and global clinical trials.
Innovations
In 2019, our team manufactured more than 10,000 vials of anti-Ebola antibody mAb114 in just over a month for a clinical trial in the Democratic Republic of Congo. The antibody would later prove to be one of the two most effective treatments in the trial.
We manufactured 38 batches of the anti-HIV antibody VRC01—more than 150,000 vials—over a five-year campaign to support the international Antibody-Mediated Prevention study.
In response to the Zika outbreak of 2015–2016, we manufactured and shipped an experimental Zika vaccine in just 90 days.
Focus
Product manufacturing and materials management
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Perform analytical method transfers and assay qualifications and validations within a few months using a dozen different assays.
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Manage analytical instrument qualifications and critical reagents.
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Perform ongoing routine product release and stability testing for all vaccine products including intermediates.
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Archive and report release and stability test data using a validated laboratory information management system.
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Sample, test, quarantine, and release incoming raw material.
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Prep drug solutions and buffers onsite using disposable Hynetics system, and store all media and buffers.
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Use fermentation-based or mammalian cell culture-based production methods for drug substance manufacturing, and oversee processing:
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Upstream processing: mammalian cell culture, including master cell banking
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Downstream processing: all modes of column chromatography purification, diafiltration-ultrafiltration, viral inactivation and viral filtration, formulation, and bulk freeze
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Produce vialed drug products ranging from 3 to 20 mL.
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Uphold Current Good Manufacturing Practice in facility operations.