Researchers can use predictive analytics to identify immunogenicity
in biotherapeutics during the discovery phase of drug development.
is a risk of every treatment based on biological drugs, and may lead not only to loss of response but also to development of adverse events (5).
In a recent US FDA review of 121 approved biological products, 89 % of them had immunogenicity
reported and in 49% of cases it impacted efficacy.
This Phase III, open-label study assessed the immunogenicity
and safety of IIV4 in adults (18-60 years) and older adults (>60 years).
The mechanisms of treatment failure can be attributed to many factors, including drug-related immunogenicity
, treatment-related factors including dosing and bioavailability issues, pharmacokinetics and pharmacodynamics of the drug, individual patient-related factors, and disease-specific differences in the pathogenic role of TNF (18).
Biologics manufacturers acknowledge the problem of immunogenicity
and discuss it in product labeling.
Located in North Carolina's Research Triangle area, BioAgilytix provides PK, immunogenicity
, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states.
8226; Tim Hickling, Immunogenicity
Sciences Discipline Lead, Pfizer
As a result, improved assays, which detect the level of antibodies raised against a specific biological, have been developed so that the extent of immunogenicity
can be more specifically determined.
PolyTherics' portfolio of services and technologies includes proprietary site-specific conjugation technologies and novel polymers for optimising the therapeutic properties of biopharmaceuticals and through its Cambridge, UK-based subsidiary, Antitope, services for protein immunogenicity
assessment and antibody and protein re- engineering technologies are delivered.
Antitope Ltd is a wholly owned subsidiary of the PolyTherics group specialising in immunogenicity
testing and the engineering of therapeutic antibodies/proteins for reduced immunogenicity
However, there were some minor differences in immunogenicity
among the four schedules.