TY - JOUR
T1 - Advances in predicting and manipulating the immunogenicity of biotherapeutics and vaccines
AU - Flower, Darren R.
PY - 2009/8/1
Y1 - 2009/8/1
N2 - Therapeutic proteins are vital to the future of human health provision and the survival and profitability of the global pharmaceutical industry. Returns from protein therapeutics are experiencing unprecedented growth: both their number and their economic dividend have increased by an order of magnitude in the last 10 years. The potential immunogenicity of protein therapeutics raises many clinical and safety concerns. Many poorly understood factors relating to both product and host affect immune responses. Available laboratory measurement of immunogenicity is of little utility for predicting the clinical properties of biotherapeutics. Coupled with assay variability and standardization issues, this precludes adequate prediction of the biological or clinical responses of therapeutic proteins, arguing for the utilization of informatic strategies in the analysis and prediction of protein immunogenicity. Currently, many unresolved issues must be addressed and thus circumvented before effective prediction can become routine.
AB - Therapeutic proteins are vital to the future of human health provision and the survival and profitability of the global pharmaceutical industry. Returns from protein therapeutics are experiencing unprecedented growth: both their number and their economic dividend have increased by an order of magnitude in the last 10 years. The potential immunogenicity of protein therapeutics raises many clinical and safety concerns. Many poorly understood factors relating to both product and host affect immune responses. Available laboratory measurement of immunogenicity is of little utility for predicting the clinical properties of biotherapeutics. Coupled with assay variability and standardization issues, this precludes adequate prediction of the biological or clinical responses of therapeutic proteins, arguing for the utilization of informatic strategies in the analysis and prediction of protein immunogenicity. Currently, many unresolved issues must be addressed and thus circumvented before effective prediction can become routine.
UR - http://www.scopus.com/inward/record.url?scp=69249222717&partnerID=8YFLogxK
UR - https://link.springer.com/article/10.2165%2F11317530-000000000-00000
U2 - 10.2165/11317530-000000000-00000
DO - 10.2165/11317530-000000000-00000
M3 - Article
C2 - 19697965
SN - 1173-8804
VL - 23
SP - 231
EP - 240
JO - BioDrugs
JF - BioDrugs
IS - 4
ER -