Poster Presentation ASSCR, AGCTS, ISCT ANZ and Friends Joint Scientific Conference 2019

Meise System Autologous Serum Eye Drops Validation (#206)

Michelle W Keir 1 , Natasha Barry 1 , Afroditi Sdrolias 1 , Zlatibor M Velickovic 1 2 , John Rasko 2 3
  1. Royal Prince Alfred Hospital, Camperdown, NSW, Australia
  2. Sydney Medical School, University of Sydney, Sydney, NSW, Australia
  3. Gene and Stem Cell Therapy Program, Centenary Institute, Sydney, NSW, Australia

Introduction

Autologous Serum Eye Drops (ASED) is used as therapy for the treatment of a number of conditions that result in dry eye syndrome. There are numerous eye drop dispensing systems, including bottles, tubes and pouches.

In this study, we evaluated the safety and suitability of the Meise dispensing system for the production and transport of ASED in order to replace the discontinued tubing system manufactured by Macopharma.

Methods

A volume of 200-300mL of whole blood was collected from three donors and allowed to clot for a minimum of 2hrs. The serum was separated from the clot into a new transfer bag and centrifuged at 3000g for 15mins and 10°C. The serum was separated from erythrocytes using the Optipress and diluted with 0.9% Sodium chloride to a final 20% serum concentration. The bag containing ASED was sterile connected to a Meise system and filled. The vials were packaged, labelled and stored in a -80°C freezer. Temperature conditions during transport were evaluated in a simulated hot environment.

Results

A negative bioburden of the final product and a transport time at -20°C for 2hrs were the acceptance criteria. Serum yield was also evaluated.

  • bioburden tests of the final ASED product were negative
  • transport time at -20°C was maintained for up to 2hrs 30min.
  • Average serum yield was 32% (range 18% to 46%)

Discussion

This validation demonstrated a better separation of serum from RBC using the Meise protocol, good serum yield and a transport time at -20°C of 2hrs, and no impact on serum eye drops bioburden results with the omission of the filtration step. Therefore the Meise eye drop system is a suitable replacement for the Macopharma tubing system.

  • Have you presented your abstract at another international meeting?: No