Naslov
Workshop: Biological therapy – from production and administration to side effects monitoring
(Workshop: Biological therapy – from production and administration to sideeffects monitoring)

Autori
Vrbanec, Damir ; Šeparović, Robert ; Pavlica, Vesna ; Skelin, Marko

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, ostalo

Skup
Biološki lijekovi i što ljekarnik treba znat

Mjesto i datum
Zagreb, Hrvatska, 2018

Vrsta sudjelovanja
Poster

Vrsta recenzije
Podatak o recenziji nije dostupan

Ključne riječi
biological therapy ; immunogenicity

Sažetak
Biological drugs belong to new set of drugs developed for various diseases. Biological drugs are produced in living cells by recombinant technology and are effective in stimulating or inhibiting the action of natural compounds. Biological drugs differ from those of chemically synthesized molecules due to their origin and their complex structure. An assiesment of immunogenicity is important for biological drugs, in line with current guidelines in preclinical and clinical studies and is included in the Pharmacovigilance Risk Managment Plan. Therapeutic proteins are produced using genetically modified cell lines or transgenic animals. Residual process contamination can be the cause of immunogenicity. Glycosylation or pegylation of molecules can mask immunogenic epitopes. Substances which migrate from primary package can stimulate creation clusters of higher immunogenic potential. The goal of the workshop is to point out basics and simple characteristics of biological medicines, a traceability of the applied biological therapy through serialization and writing of protected names of the drug as well as indicating the follow up and reporting of side effects. Presentation of cases associated with a particular biological therapy will point to the critical points of the biological drug tracking chain from receiving drugs in hospital pharmacy, to the application of drug and reporting of observed side effects.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA