Drug levels, immunogenicity and assessment of active sacroiliitis in patients with axial spondyloarthritis under biologic tapering strategy.

The aim of the study was to assess drug levels, immunogenicity and sacroiliitis on MRI in patients with axial spondyloarthritis under biologic tapering strategy. Consecutive patients with axial spondyloarthritis who remained in low disease activity more than 1 year after dose tapering of infliximab and adalimumab were included. Plasma drug concentrations of TNF inhibitors and anti-drug antibodies were determined, and MRI of sacroiliac joints was evaluated. Of twenty patients included, eighteen had therapeutic drug levels, no patient had anti-drug antibodies, and no patient had active sacroiliitis on MRI. These data could support the biologic tapering strategy and their maintenance over time.

Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma Suppliers.

Manufacturers of human plasma-derived products ensure, through their qualification departments, the quality and safety of human plasma-the biological starting material of the industrial fractionation process. The qualification department has established written procedures to approve the plasma supplier (i.e., initial qualification) according to current regulations and to the manufacturer's plasma specifications. Once the plasma supplier is approved, a periodical assessment is necessary (i.e., continuous qualification) to guarantee the level of compliance. In addition, a signed quality agreement between the plasma supplier and the manufacturer defines the duties and the responsibilities of both parties. The qualification department implements the following requirements to ensure the quality of plasma from suppliers: (i) a regular audit program to confirm the satisfactory initiation of the quality arrangements and (ii) monitoring of the quality and safety of plasma including critical quality parameters. For several years, the Grifols Qualification Department has worked with several plasma suppliers of the European Union (EU) and has performed a detailed, continuous assessment of the audits, deviations, operational incidences, epidemiological data, and quality controls. In this article, we will report data from this Grifols assessment from 2010 through 2013 on plasma suppliers from four EU countries. In the future, additional data will be collected and studied to confirm and verify the conclusions and trends observed in this study.

A 90-day subchronic toxicological assessment of Antrodia cinnamomea in Sprague-Dawley rats.

Antrodia cinnamomea (Ac) is a medicinal mushroom widely used for the treatment of abdominal pain, hypertension and hepatocellular carcinoma, but subchronic toxicity of this material has not yet been investigated. This present study was conducted to assess the 90-day oral toxicity of A. cinnamomea from submerged culture in male and female Sprague-Dawley (SD) rats. Eighty rats were divided into four groups, each consisting of ten male and ten female rats. Test articles were administered by oral gavage to rats at 3000, 2200 and 1500 mg/kg BW/day for 90 consecutive days and reverse osmosis water was used as control. All animals survived to the end of the study. During the experiment period, no abnormal changes were observed in clinical signs, body weight and ophthalmological examinations. No significant differences were found in urinalysis, hematology and serum biochemistry parameters between the treatment and control groups. Necropsy and histopathological examination indicated no treatment-related changes. According to the above results, the no-observed-adverse-effect level (NOAEL) of Antrodia cinnamomea is identified to be greater than 3000 mg/kg BW/day in Sprague-Dawley rats.