Such results are assumed to indicate differences in immunogenicity of the vaccines that relate to the T cell help induced by the different carrier proteins, though there are other manufacturing differences between MenC-TT and MenC-CRM that make it difficult to formally draw this conclusion.
It was shown that manufacturing differences of brachytherapy seed cause considerable changes in dose distribution.
Whether or not these manufacturing differences translate into differences in vivo, as well as clinical outcomes, is a matter of discussion.
According to Silver, 5 the manufacturing differences between intraocular aflibercept and intravenous ziv-aflibercept are proprietary but unlikely to account for the 100-fold price differential.
Manufacturing differences between a biosimilar and its reference product can lead to differences in molecular structure (e.g., glycosylation), content (e.g., isoforms, impurities, and aggregates), biological activity, and immunogenicity.
Chip manufacturing differences such as probe selection, processing protocols, and spot normalization algorithms contribute to variability that can distort mRNA transcript abundance measurements and introduce inconsistencies to hinder cross-platform comparisons.
From a cost perspective, aP antigens have historically exceeded the cost of wP antigens by a factor of ten to more than 30 due to manufacturing differences and royalty costs.
Robust safety monitoring of all biologics is important to track and accurately attribute adverse events, particularly because their inherent complexity and manufacturing differences make them susceptible to structural changes that can affect safety (e.g., immunogenicity).
Here, we provide an overview of biosimilars and discuss key considerations for practicing U.S. oncologists, including biosimilar structural complexity, manufacturing differences, regulatory approval, clinical trials, interchangeability, extrapolation of indications, safety monitoring, naming, economics, and reliability of supply.
(Table 2) According to a report from Oliver Wyman, commissioned by Bill and Melinda Gates Foundation and published in 2010, the cost of aP antigens have historically exceeded the cost of wP antigens by a factor of ten to more than 30 due to manufacturing differences and royalty costs.
