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MelCancerVac is a cancer vaccine that consists of patients DCs loaded with cell lysate of a well-characterised allogeneic melanoma cell line expressing high levels of MAGE antigens.For such a vaccine it is vital to ensure not only that the DCs are functionally immunogenic, but also that they present lysate-derived tumour antigens, a prerequisite for induction of specific anti-turnout T cell responses in the patient.Whilst methods for assessing the immunogenicity of DCs have been well-characterised and standardised in our cGMP lab, the demonstration of the potency by which lysate-derived tumour antigens are presented in MelCancerVac has been difficult to measure due to the polytopic nature of the tumour lysate.MelCancerVac(R) has been tested in several clinical trials which have been conducted in our cGMP facilities.So far MelCancerVac(R) has shown promising results in phase Ⅱ clinical trials in patients with colorectal cancer and in patients with non small cell lung cancer.Our experiences with cGMP issues are positive although some regulations were hard to meet.Based on our trials we have made it possible to make QC guidelines (e.g.FACS profiling) of vaccines produced for our future clinical trials.