Serum growth factor stability in different eye drop packaging systems during storage.
Transfus Apher Sci
; 59(1): 102608, 2020 Feb.
Article
em En
| MEDLINE
| ID: mdl-31320279
ABSTRACT
Serum eye drops (SED) have shown beneficial effects in patients suffering from dry eye syndrome and are manufactured for an increasing number of patients in Australia every year. Previous studies have examined the stability of serum growth factors during storage in either experimental vessels not used as the final packaging system or in eye drop bottles. To ensure the quality and safety of SED product manufactured in Australia, the stability of growth factors in serum packaged into two different systems during storage at different temperatures was examined. Healthy blood donors provided a whole blood donation, from which serum was prepared, diluted to 20% and dispensed into either a tube or a vial packaging system. The stability of growth factors, fibronectin and total protein in tube segments was comparable to matched vials samples during storage at -30⯰C, 4⯰C, 22⯰C and 37⯰C, with the exception of EGF and fibronectin in 20% SED stored in tube segments, which were more sensitive to storage conditions at 4⯰C and 22⯰C when compared to vials. Additionally, the growth factor, fibronectin and total protein concentration in both tube segments and vials was stable during storage at -30⯰C for at least 9 months. This study highlights the impact of different manufacturing procedures on serum growth factor stability during storage.
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Soluções Oftálmicas
/
Embalagem de Produtos
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Peptídeos e Proteínas de Sinalização Intercelular
Limite:
Humans
Idioma:
En
Revista:
Transfus Apher Sci
Assunto da revista:
HEMATOLOGIA
Ano de publicação:
2020
Tipo de documento:
Article