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Ideally, to be predictive of an in vivo effect, in vitro neutralization assays should mimic the in vivo conditions under which nAbs encounter virus as closely as possible

503B Facilities must meet FDA cGMP requirements, conduct batch release testing, and are inspected by the FDA, offering higher sterility assurance

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Kacharava T, Giorgadze E, Janjgava S, Lomtadze N, Iamze T

We understand that reliable data depends on reliable materials, which is why our quality control processes are designed to meet the high standards expected by the scientific community

in some embodiments, the gel formulation also has an immediate or rapid release component for delivery of the active agent to the desired target site