Since the impact of immunogenicity can be quite severe, regulatory agencies are developing risk-based guidelines for immunogenicity screening.
32.
In addition the secondary objectives are overall survival, response rate, pharmacokinetics, immunogenicity, safety, and biomarker analysis.
33.
These seemingly minute structural changes can affect preclinical stability and process optimization as well as therapeutic product potency, bioavailability and immunogenicity.
34.
A secondary goal is to guide selection of vaccine dosage levels for expanded Phase II trials based on reactogenicity and immunogenicity profiles.
35.
Additionally, it suggested other applications in which epitope-mapping tools could be used including autoimmunity, transplantation, and immunogenicity.
36.
In the rush to deliver novel biologics to market, developers have, on occasion, overlooked factors that contribute to protein immunogenicity.
37.
Immunoediting is a process by which a person is protected from cancer growth and the development of tumour immunogenicity by their immune system.
38.
In prime-boosting, one type of vaccine is followed by a boost with another type in an attempt to improve immunogenicity.
39.
The World Health Organization will facilitate the establishment of the target product profile and assess the quality, safety and immunogenicity of AMC vaccines.
40.
Vogelstein said the Onyx viruses were a clever approach but, even though very promising, they had problems of immunogenicity and delivery to overcome.
