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 a corresponding product specification is inextricably linked to the tolerance for error in assigning a dose value for a vector lot. By adopting an equivalence-based lot release model which includes a total error approach to assay qualification, specific testing strategies can be evaluated quantitatively for dose error and lot release decision risks throughout the drug development process. This article aims to reinforce how the concepts tied to an equivalence-based lot release model are interrelated and applied in practice. It provides in-depth explanations of fundamental concepts and clarifies common misunderstandings for quality control, quality assurance, and regulatory affairs personnel held accountable for decisions made in vector dose assignment and product lot release.
Tag: <span>quality assurance</span>
The enzyme-linked immunospot (ELISpot) assay is one of the most useful techniques for the immunological monitoring of vaccine trials and has increasing application as a measure of specific T-cell activation. Recently, we developed, optimized, and validated a customized ELISpot kit for the detection of interferon gamma (IFNγ) positive cells. The precision of the ELISpot was good and it varied over the range of the assay values, independent of the stimulus. Here we describe the development of a library of donors with characterized responses to the CEF peptide pool: cytomegalovirus (CMV), Epstein-Barr virus (EBV), and influenza (Flu); pool of 32 peptides which can be used as controls for IFNγ ELISpot and multiple immune monitoring assay validations for use in clinical trials…
The Dale and Betty Bumpers Vaccine Research Center (VRC) at the National Institutes of Health (NIH) was established to facilitate research in vaccine development. The VRC is dedicated to improving global human health through the rigorous pursuit of effective vaccines for human diseases. It was established by former president Bill Clinton as part of an initiative to help develop an AIDS vaccine and is part of the NIAID organization. Since the inception of the VRC, its mission has expanded to include the development of vaccines against bioterrorism and emerging infectious diseases…
New regulatory initiatives often produce paranoid responses. These over-reactions are often a result of initial rumors fueled by less-than scrupulous consultants or by misinterpreted statements reported out of context from unscripted regulators. The “remote monitoring capability” incorporated into the emerging Process Analytical Technology (www.fda.gov/cder/OPS/PAT.htm) initiative is a prime example. Put the fear back in the closet: remote monitoring will not lead to unannounced or secret FDA electronic visits, unscheduled remote audits, or regulatory spying on industry processing activities…