Biofarmaceutici podrijetlom iz ljudske plazme

professional thesis

• Author: Jasna Safić
• Mentor: Ivan Pepić (mentor)
• Mentor: Vesna Bačić Vrca (sumentor)
• Committee member: Jasmina Lovrić (predsjednik povjerenstva)
• Committee member: Ivan Pepić (član povjerenstva)
• Committee member: Marjana Durrigl (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmaceutical technology); Zagreb
• Defense date and country: 2016, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Cilj:
Pregledno prikazati i usporediti klasične i suvremene industrijske postupke proizvodnje, opisati posebnosti u formulacijskim, regulatornim i farmakovigilancijskim zahtjevima, te istaknuti najvažnije kliničke značajke biofarmaceutika iz ljudske plazme.
Materijal i metode:
Pretraživala se literatura u bibliografskim bazama podataka (PubMed, ScienceDirect) prema osnovnim ključnim riječima. Članci prikupljeni pretraživanjem razvrstani su od općih prema specijaliziranim pri čemu su odabrani relevantni članci, a koji su zatim proučavani na analitički i kritički način. U radu su navedeni najvažniji rezultati, kao i vlastita razmatranja.
Rezultati:
Biofarmaceutici iz ljudske plazme dobiveni suvremenim tehnikama proizvodnje imaju značajno industrijsko poboljšanje iskorištenja sirovine i visok stupanj sigurnosti. Unatoč uvođenju metoda uklanjanja virusa, još se uvijek ne može sasvim isključiti rizik od prijenosa uzročnika krvlju prenosivih bolesti putem ovih lijekova. Registracijski postupci predviđaju pripremanje posebne dokumentacije koja prati kvalitetu plazme (Glavna dokumentacija o plazmi). Osim prijenosa uzročnika krvlju prenosivih bolesti, glavni rizici primjene su i trombotski događaji.
Zaključak:
Biofarmaceutici iz ljudske plazme dobivaju se iz krvi ili plazme dobrovoljnih davatelja postupcima frakcioniranja. Industrijska proizvodnja biofarmaceutika iz ljudske plazme složen je i zahtjevan tehnološki proces. Biofarmaceutici podrijetlom iz ljudske plazme nalaze se na Popisu esencijalnih lijekova Svjetske zdravstvene organizacije i često se primjenjuju kod bolesti opasnih po život, te predstavljaju klinički nezamjenjivu skupinu lijekova.

Abstract (english)

Objectives:
Systematically review and compare the traditional and modern industrial production processes, describe the special features in the formulation, regulatory and pharmacovigilance requirements, and highlight the most important clinical features of plasma-derivated biopharmaceutical products.
Material and methods:
The literature was searched in bibliographic databases (PubMed, ScienceDirect) according to the primary keywords. Articles obtained by searching of the literature were classified from general to more specialized. Relevant articles are selected, and then examined in an analytical and critical way. The most important results, as well as own considerations are quoted in the overview.
Results:
Plasma-derivated biopharmaceutical products obtained by modern production techniques have significantly enhanced the industrial utilization of raw materials and high degree of safety. Despite of introduction of the virus reduction methods, the transmission of blood-born infection by these medicinal products still cannot be excluded. Registration procedures request the preparation of special documentation which accompanies the quality of plasma (Plasma Master File). Beside the transmission of blood-born infection, the most important risks of administration are thrombotic events.
Conclusion:
Plasma-derivated biopharmaceutical products are obtained by fractionation procedures from blood or plasma of volunteer donors. Industrial production of plasma-derivated biopharmaceutical products is a complex and demanding process technology. Plasma-derivated biopharmaceutical products are on the list of essential medicines of the World Health Organization and they are often administered to life-threatening diseases and represent an irreplaceable group of clinical drugs.

• Keywords: biofarmaceutici; krvna plazma
• Keywords (english): biopharmaceutics; blood plasma
• Language: croatian
• URN:NBN: urn:nbn:hr:163:449308
• Study programme: Title: Clinical pharmacy; Study programme type: university; Study level: postgraduate specialist; Academic / professional title: sveučilišni/a magistar/sveučilišna magistra kliničke farmacije (sveučilišni/a magistar/sveučilišna magistra kliničke farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2016-03-04 16:24:24