Environmental Health and Safety Offers a Biosafety Risk Assessment for a Theoretical Model of a Gene Therapy Process Transfer from Research and Development to Large-Scale Manufacturing.

Introduction: This article provides a strategy by which a manufacturing process with a Biosafety Level 2 (BL2) designation can be downgraded to Biosafety Level 1 (BL1). The principles of the downgrading process are based on the robust contamination controls in clinical and commercial manufacturing, which typically are not part of Research and Development processes. These strict requirements along with the application of current Good Manufacturing Practice (cGMP) principles provide a framework by which processes can be suitably managed and controlled to mitigate biohazard risk, specifically for cell lines that may be contaminated with human pathogenic viral agents.

Depression, cortisol and somatoform dissociative symptoms.

Objective: According to recent findings neuroendocrine response related to dissociative symptoms is related to dysregulation of the hypothalamus-pituitary-adrenal (HPA) axis but HPA axis functioning as related to dissociation is only partially understood.

Method: With the aim to test the relationship between basal serum cortisol and dissociative symptoms measured as somatoform and psychic dissociation we performed clinical testing and biochemical analysis in 30 inpatients with diagnosis of unipolar depression (mean age 41.46, SD=13.

Dissociation, epileptic-like activity and lateralized electrodermal dysfunction in patients with schizophrenia and depression.

Objectives: Recent evidence indicates frequent EEG abnormalities in dissociated patients. This evidence is in agreement with findings that in certain psychiatric patients, psychosensory symptoms of epileptogenic nature, the so-called complex partial seizure-like symptoms occur. With respect to these findings, a hypothesis examined in this study states that increased level of experienced traumatic stress and dissociation in pathological conditions such as schizophrenia or depression relates to increased score of complex partial seizure-like symptoms.

Depression, prolactin and dissociated mind.

Objectives: Usual neuroendocrinological manifestation of traumatic stress and dissociation is dysregulation of the hypothalamus-pituitary-adrenal (HPA) axis. The aim of the present study is to perform examination of HPA axis as indexed by basal serum prolactin and test its relationship to dissociative symptoms and symptoms of traumatic stress.

Patients And Methods: 25 inpatients treated at the university hospital with diagnosis of unipolar depression mean age 41.

Infectious diseases in disaster areas/catastrophes.

There is very little data and no prospective research possible in the field of catastrophic medicine (disaster medicine) including infectious diseases. This minireview tries to contribute to the pathogenesis and outcome of infectious diseases in areas after anthropogenic (war, genocide, terrorist attack, industrial disasters) and non anthropogenic (natural) catastrophes (earthquake, floods, tsunamis, hurricanes, volcano eruptions). Therefore ISC received a proposal to create a working group on infectious diseases in areas after catastrophes, better to understand epidemiology, prevention and therapy of infectious diseases occurring in conjunction to various anthropogenic and non anthropogenic (natural) disasters.