Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction.

In the past decade, stem cell therapy has been increasingly employed for the treatment of various diseases. Subsequently, there has been a great interest in the manufacture of stem cells under good manufacturing practice, which is required by law for their use in humans. The cells for sight Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell-based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital (London, UK).

Stem cell therapy delivery: treading the regulatory tightrope.

The concept of stem cell therapy has engaged the attention of the public and scientists alike. Intensive research effort is focused upon understanding the biology and therapeutic potential of embryonic and adult stem cells, with the eventual goal of treating such pathologies as Parkinson's disease, diabetes, neurological injury and degenerations and cancer. Ex vivo expansion and transplantation of limbal epithelial stem cells to the corneas to treat blinding ocular surface disease was one of the first stem cell therapies to successfully reach the clinic.

Validation of alternative methods of preparing 99mTc-MAG3.

Parameters in the preparation of 99mTc-mertiatide (99mTc-MAG3) were investigated to determine the importance of total activity, activity concentration, boiling time, and delay before boiling for the radiochemical purity (RCP) and stability of the product. Satisfactory RCP results (>90%) were obtained over a range of concentrations including a dilute preparation for paediatric use. RCP was not affected by the time between the addition of pertechnetate and boiling, but low RCP (<60%) resulted when the kit was boiled for less than 10 min.

Simplified method for determining the radiochemical purity of 99mTc-MAG3.

Unlabelled: 99mTc-Mercaptoacetyltriglycine is used for dynamic renal imaging, and the summary of product characteristics (SPC) for the European formulation specifies a shelf life of 1 or 4 h, depending on the reconstitution volume of the kit. To minimize the time required to test the radiochemical purity, a simplified quality control method was developed.

Methods: To satisfy the recommendations of the International Commission on Harmonisation, results obtained with the methods described in the European and American SPCs were compared with those obtained with the simplified method.