Development and qualification of a representative scale-down model of automated Ficoll-based processing of a cell-based therapeutic according to quality by design principles.

Background Aims: This article describes the development of a small-scale model for Ficoll-based cell separation as part of process development of an advanced therapy medicinal product and its qualification. Because of the complexity of biological products, their manufacturing process as well as characterization and control needs to be accurately understood. Likewise, scale-down models serve as an indispensable tool for process development, characterization, optimization and validation.

[Efficiency of in vitro culture of Toxoplasma gondii in THP1 and Vero cell lines].

Introduction: Cell culture is an important method for isolating Toxoplasma gondii to make clinical diagnosis or for biotechnological purposes.

Objective: The percentage of invasion and production levels of T. gondii was determined for THP1 and Vero cell lines.

Infectious agents associated with schizophrenia: a meta-analysis.

Schizophrenia is a highly disabling and limiting disorder for patients and the possibility that infections by some microorganisms may be associated to its development may allow prevention and recovery. In the current study we have done a meta-analysis of studies that have assessed the possible association between detection of different infectious agents and schizophrenia. We report results that support the idea that there is a statistically significant association between schizophrenia and infection by Human Herpesvirus 2 (OR=1.

Low intrathecal immune response of anti-EBNA-1 antibodies and EBV DNA from multiple sclerosis patients.

Numerous studies have been carried out to determine whether an Epstein-Barr virus (EBV) infection can be considered a risk factor for multiple sclerosis (MS), following the evidence of an increase in IgG response to nuclear antigen-1 (EBNA-1) in both serum and cerebrospinal fluid (CSF) from MS patients. However, the possible interaction between EBV and MS has still not been well characterized, and the possible pathogenic role is yet to be determined. A case-control study (76 cases and 75 controls) was conducted to investigate anti-EBV antibodies synthesis in serum and CSF through intrathecal specific IgG synthesis to EBNA-1, as well as the presence of EBV DNA in plasma, peripheral blood mononuclear cells, and CSF from MS patients.

Serological diagnosis of Chlamydia pneumoniae infection: limitations and perspectives.

Chlamydia pneumoniae is an obligate intracellular human pathogen responsible for a wide range of acute and chronic human diseases, including pneumonia and other respiratory diseases. Serological methods for the diagnosis of C. pneumoniae infection vary widely, and several authors have reported significant inter- and intra-laboratory variability in diagnostic methods and criteria.

Antimicrobial development in the era of emerging resistance.

Antibiotics currently under study by the Food and Drugs Administration include: faropenem (for treatment of sinusitis, bronchitis, and community-acquired pneumonia), dalbavancin (for catheter infections), telavancin (for treatment of nosocomial pneumonia), oritavancin (for bacteremia), ceftobiprole and iclaprim (for pneumonias). Moreover, all of them would be useful for skin and soft tissue infections.

[Chlamydophila pneumoniae: from its proteomics to arteriosclerosis].

Chlamydophila pneumoniae is a highly prevalent intracellular human pathogen with a unique biphasic life cycle. It is a common cause of upper respiratory infection and pneumonia, and is currently being studied as a potential risk factor for the development of atherosclerotic cardiovascular disease. The outer membrane surface antigens of C.