Allogenic and autologous nondiluted serum eye drops-validation strategy compliant with good manufacturing practice.

Background And Aims: Serum eye drops alleviate ocular symptoms of diseases such as sicca syndrome, or chronic graft-versus-host disease. This study was designed for good manufacturing practice validation of our standard manufacturing, storage and transport processes for both autologous and allogenic SEDs. Specifications of quality parameters are lacking and were aimed to be defined.

Validation of an apoptosis assay for extracorporeal photopheresis.

Objectives: This validation study investigated a flow cytometric apoptosis assay according to good manufacturing practice (GMP).

Background: Extracorporeal photopheresis (ECP) is a treatment for various immunological diseases and cutaneous T-cell lymphomas. It is based on the induction of apoptosis by 8-methoxypsoralene and ultraviolet A light.

A method for the quantification of 8-methoxypsoralen by mass spectrometry for offline extracorporeal photopheresis.

Background: Extracorporeal photopheresis (ECP) is an efficient method to treat various autoimmune diseases, cutaneous T-cell lymphoma, and graft-versus-host disease. It is based on the ex vivo inactivation of lymphocytes by 8-methoxypsoralen (8-MOP)/UV light treatment. Despite the adhesive, lipophilic nature of 8-MOP, no quality control is established for the ECP procedure.

Granulocytapheresis with modified fluid gelatin versus high-molecular-weight hydroxyethyl starch: a matched-pair analysis.

Background: Granulocyte apheresis requires a sedimentation agent. Usually, hydroxyethyl starch (HES) is administered to donors for this purpose and, as granulocyte concentrate (GC) ingredient, also to patients. Authorities recently recommended suspending market authorizations for starch-containing products due to side effects.