For many applications, human clinical therapies using retroviral vectors still require many
technological improvements in key areas of vector design and production. These …

In the course of preparing a revision to Chapter <111> of the US Pharmacopeia, the revision
committee came to a unanimous agreement that the method for assessing parallelism that …

In a phase 1 clinical trial, we are evaluating a murine leukemia virus (MuLV)-based retroviral
vector encoding the human factor VIII gene [hFVIII(V)], administered intravenously, as a …

An international hybrid meeting held 21–22 June 2023 in Ottawa, Canada brought together
regulators, scientists, and industry experts to discuss a set of principles and best practices in …

… C ells were harvestedina S orval GSA rotor at 10,000 xg, 4 C, for 12 min. … N ative and
denaturing gels were placed at 4 C and -70 C respectively. DNA sequencing gels were dried onto …

A murine retroviral vector encoding the human immunodeficiency virus type 1 (HIV-1) env
and rev genes can be used to induce cytotoxic T lymphocyte responses. Immune responses …

P re-clinical and clinical trials conducted to establish the minimum effective dose and the
maximum tolerated dose of a viral vector assume that the assigned dose values are …

To demonstrate that a dose-determining assay is fit for purpose, the measurement uncertainty
associated with a reported release test result must be suitably small. The establishment of …

In a phase 1 dose escalation study, 13 subjects with hemophilia A received by peripheral
intravenous infusion a retroviral vector carrying a B-domain–deleted human factor VIII (hFVIII) …

84 BioProcessing Journal• September/October 2003 sible components in a vector preparation
(Table 1) and the relative contribution that each makes to the overall composition. Then …