(UL)
-
Effects of monoclonal antibody concentration and type of bulking agent on critical quality attributes of lyophilisatesBjelošević Žiberna, Maja ; Ahlin Grabnar, PegiBiopharmaceuticals represent one of the fastest growing areas in the pharmaceutical industry. Previously, protein formulations for intravenous applications were most widespread, while now the ... subcutaneous route of administration is gaining importance. Subcutaneous administration requires high concentrations of protein drugs. Lyophilisation represents the method of choice for drying such formulations. In this study the effects of monoclonal antibody (mAb) ''drug'' concentration on the thermal characteristics and viscosities of pre-lyophilised formulations were determined. Additionally, the effects of mAb concentration on reconstitution time, cake appearance and mAb stability were evaluated. The main aim of the study was to investigate the effects of amino acids as selected bulking agents and their ratios to sucrose on the critical quality attributes of lyophilisate formulations at low and high mAb concentrations, as a comparison with the most commonly used mannitol formulations. Harsher aggressive drying conditions did not have any major impact on the critical quality attributes of lyophilisates or on mAb stability, while primary drying time was shortened by up to 80%. The isoleucine:sucrose ratio of 1:4 provided a lyophilised cake with superior macroscopic appearance for low and high mAb concentrations despite aggressive drying, which greatly shortened lyophilisation time. However, the drawback of isoleucine in high protein concentration formulations is the long reconstitution time. In contrast, for low mAb concentrations, an isoleucine:sucrose ratio of 1:4 is promising for replacement of mannitol, as it provides suitable reconstitution time, cake appearance and mAb stability.Vir: Journal of drug delivery science and technology. - ISSN 1773-2247 (Vol. 63, 2021, str. 1-10)Vrsta gradiva - članek, sestavni del ; neleposlovje za odrasleLeto - 2021Jezik - angleškiCOBISS.SI-ID - 59599363
Avtor
Bjelošević Žiberna, Maja |
Ahlin Grabnar, Pegi
Teme
Farmacevtska industrija |
Sušenje |
monoclonal antibody |
subcutaneous administration |
lyophilisation |
bulking agent |
amino acids |
isoleucine |
liofilizacija |
biofarmacevtiki |
amino kisline |
monoklonsko protitelo |
subkutana aplikacija |
polnila |
izolevcin
Vnos na polico
Trajna povezava
- URL:
Faktor vpliva
Dostop do baze podatkov JCR je dovoljen samo uporabnikom iz Slovenije. Vaš trenutni IP-naslov ni na seznamu dovoljenih za dostop, zato je potrebna avtentikacija z ustreznim računom AAI.
Leto | Faktor vpliva | Izdaja | Kategorija | Razvrstitev | ||||
---|---|---|---|---|---|---|---|---|
JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
Baze podatkov, v katerih je revija indeksirana
Ime baze podatkov | Področje | Leto |
---|
Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
---|---|
Bjelošević Žiberna, Maja | 38497 |
Ahlin Grabnar, Pegi | 15490 |
Vir: Osebne bibliografije
in: SICRIS
Izberite prevzemno mesto:
Prevzem gradiva po pošti
Naslov za dostavo:
Med podatki člana manjka naslov.
Storitev za pridobivanje naslova trenutno ni dostopna, prosimo, poskusite še enkrat.
S klikom na gumb "V redu" boste potrdili zgoraj izbrano prevzemno mesto in dokončali postopek rezervacije.
S klikom na gumb "V redu" boste potrdili zgoraj izbrano prevzemno mesto in naslov za dostavo ter dokončali postopek rezervacije.
S klikom na gumb "V redu" boste potrdili zgoraj izbrani naslov za dostavo in dokončali postopek rezervacije.
Obvestilo
Trenutno je storitev za avtomatsko prijavo in rezervacijo nedostopna. Gradivo lahko rezervirate sami na portalu Biblos ali ponovno poskusite tukaj kasneje.
Gesla v Splošnem geslovniku COBISS
Izbira mesta prevzema
Gradivo iz matične enote je brezplačno. Če je gradivo na mesto prevzema dostavljeno iz drugih enot, lahko knjižnica to storitev zaračuna.
Mesto prevzema | Status gradiva | Rezervacija |
---|
Rezervacija v teku
Prosimo, počakajte trenutek.
Rezervacija je uspela.
Rezervacija ni uspela.
Rezervacija...
Članska izkaznica:
Mesto prevzema: