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Evaluation of the Storage Stability of Extracellular Vesicles
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Serum growth factor stability in different eye drop packaging systems during storage.

Joanne C G Tan1, Rachel G Webb2, Denese C Marks1

  • 1Research and Development, The Australian Red Cross Blood Service, Sydney, NSW, Australia; Sydney Medical School, The University of Sydney, NSW, Australia.

Transfusion and Apheresis Science : Official Journal of the World Apheresis Association : Official Journal of the European Society for Haemapheresis
|July 20, 2019
PubMed
Summary

Serum eye drops (SED) stability was assessed in two packaging systems. Most growth factors remained stable, but EGF and fibronectin showed sensitivity in tubes at room temperature.

Keywords:
Epidermal growth factorFibronectinPlatelet-derived growth factorSerum eye dropsStability

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Area of Science:

  • Ophthalmology
  • Biotechnology
  • Biochemistry

Background:

  • Serum eye drops (SED) are increasingly used for dry eye syndrome in Australia.
  • Previous research on SED stability used non-final packaging or standard eye drop bottles.
  • Ensuring the quality and safety of Australian-manufactured SED requires understanding storage stability.

Purpose of the Study:

  • To evaluate the stability of growth factors, fibronectin, and total protein in serum packaged in two different systems.
  • To compare the stability of these components under various storage temperatures (-30°C, 4°C, 22°C, 37°C).
  • To inform manufacturing procedures for Australian SED products.

Main Methods:

  • Serum was prepared from healthy donors, diluted to 20%, and dispensed into tube or vial packaging systems.
  • Stability of growth factors, fibronectin, and total protein was assessed over time at different temperatures.
  • Comparisons were made between tube and vial storage conditions.

Main Results:

  • Growth factors, fibronectin, and total protein were generally stable in both tubes and vials across tested temperatures.
  • EGF and fibronectin in 20% SED stored in tubes were less stable at 4°C and 22°C compared to vials.
  • All components remained stable in both packaging types at -30°C for at least 9 months.

Conclusions:

  • Packaging systems and storage temperatures significantly impact serum growth factor stability in SED.
  • While generally stable, specific components like EGF and fibronectin require careful consideration of packaging and storage conditions.
  • Manufacturing procedures must account for these factors to ensure the quality and efficacy of Australian-made SED.