Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.

Microbial challenge in-use studies are performed to evaluate the potential for microbial proliferation in preservative-free single-dose biological products after first puncture and potential accidental contamination during dose preparation (e.g., reconstitution or dilution) and storage.

The impact of the Covid-19 pandemic and government intervention on active mobility.

With data from automated counting stations and controlling for weather and calendar effects, we estimate the isolated impacts of the "first wave" of Covid-19 pandemic and subsequent government intervention (contact restrictions and closures of public spaces) on walking and cycling in 10 German cities. Pedestrian traffic in pedestrian zones decreases with higher local incidence values, and with stricter government intervention. There are ambiguous effects for cycling, which decreases in cities with a higher modal share of cycling, and increases in others.

ICH: Strengths, Weaknesses, and Future Tasks.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) started in 1990 with the mission to harmonize technical guidelines and obligations for the development and authorization of human pharmaceuticals through the cooperation of drug regulatory authorities and the pharmaceutical industry of the main drug markets in the world. To evaluate the achievements of ICH over the last 23 years, 30 European experts were interviewed. The interviewee panel was selected to encompass representatives of both the pharmaceutical industry (20 interview partners) and the health authorities (10 interview partners).

Hsp42 is required for sequestration of protein aggregates into deposition sites in Saccharomyces cerevisiae.

The aggregation of proteins inside cells is an organized process with cytoprotective function. In Saccharomyces cerevisiae, aggregating proteins are spatially sequestered to either juxtanuclear or peripheral sites, which target distinct quality control pathways for refolding and degradation. The cellular machinery driving the sequestration of misfolded proteins to these sites is unknown.

Chronic pancreatitis is associated with disease-specific regulatory T-cell responses.

Background & Aims: Chronic pancreatitis is characterized by alternating phases of acute inflammation and quiescent disease. Involvement of T-cell responses has been suggested, but pancreatitis-specific T cells have not been described.

Methods: We characterized T-cell responses against pancreatitis, pancreatic carcinoma-associated antigens, and tetanus toxoid in the bone marrow, blood, and/or pancreatitis lesions of patients with pancreatitis, pancreatic cancer, and healthy individuals.

Tumor infiltrating T lymphocytes in colorectal cancer: Tumor-selective activation and cytotoxic activity in situ.

Objective: To examine whether tumor-selective infiltration, activation, and cytotoxic activity of tumor infiltrating T lymphocytes (TIL) can be demonstrated in situ in colorectal cancer samples.

Summary Background Data: Recent studies indicated a correlation between the presence of TIL and an improved prognosis in colorectal cancer. However, tumor-selective activation and cytotoxic activity of CD8 TIL in situ in colorectal cancer patients have not yet been examined.