Fryeschulz7005

Small-scale models that simulate large-scale freezing of bulk drug substance of biopharmaceuticals are highly needed to define freezing and formulation parameters based on process understanding. We evaluated a novel scale-down device (SDD), which is based on a specially designed insulation cover, with respect to changes in concentration after freezing, referred to as cryoconcentration, and 3D temperature profiles. Furthermore, the effect of the initial monoclonal antibody (mAb) concentration on cryoconcentration was addressed.

2L and 125mL bottles were utilized. Temperatures were mapped using type T thermocouples. Frozen blocks were cut and mAb and histidine concentrations were analysed by HPLC. In addition, concentration- and temperature-dependent viscosities were measured.

3D freezing profiles in the SDD were comparable to large-scale bottles. The SDD accurately predicted cryoconcentration of both mAb and histidine of large-scale freezing. Concentric changes in concentration were evident as well as an unforeseen diluted core at the last point to freeze. At low initial mAb concentration cryoconcentration was substantial, while high initial mAb concentration suppressed cryoconcentration almost completely.

The novel SDD gives detailed insights into large-scale freezing of mAb solutions using only a fraction of the simulated volume. check details It is a promising material- and cost-saving tool to understand large-scale freezing processes.

The novel SDD gives detailed insights into large-scale freezing of mAb solutions using only a fraction of the simulated volume. It is a promising material- and cost-saving tool to understand large-scale freezing processes.

The aim of this study was to evaluate the effect of blood loss and transfusion requirements on clinical outcomes of patients treated by fenestrated-branched endovascular aortic repair (F-BEVAR) for pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs).

We reviewed the clinical data of 370 consecutive patients (277 male, mean age 74 ± 10years) treated by F-BEVAR between 2007 and 2017. Outcomes were estimated blood loss (EBL), use of intraoperative blood salvage (IOBS), transfusion of packed red blood cells (PRBCs), mortality, and major adverse events (MAEs).

There were 189 patients (51%) treated for PRAs and 181 patients (49%) treated for TAAAs. IOBS was used in 194 patients (52%) and transfusion of PRBCs was needed in 137 (37%). Thirty-day mortality was 2.2% (8/370) and MAEs occurred in 123 patients (33%), including 74 patients (20%) who had EBL > 1L. EBL > 1L and transfusion of PRBCs were significantly higher (P < 0.05) in patients treated in the first half of clinical experience and in those with larger aneurysms, iliofemoral conduits, bilateral open surgical femoral access and Extent I-III TAAAs. Use of DrySeal

sheaths (WL Gore, Flagstaff AZ) was associated with significantly lower (P < .05) EBL volume and with less transfusion of PRBCs. On multivariate analysis PRBCs > 1L, male gender and the last half of clinical experience were associated with MAEs/mortality.

F-BEVAR was associated with significantly higher volume of blood loss and transfusion requirements in patients treated in the early experience and in those who had iliofemoral conduits, open femoral surgical exposure or Extent I-III TAAAs.

F-BEVAR was associated with significantly higher volume of blood loss and transfusion requirements in patients treated in the early experience and in those who had iliofemoral conduits, open femoral surgical exposure or Extent I-III TAAAs.

Recurrent hemarthrosis of the knee is an uncommon but potentially debilitating occurrence with multiple etiologies, including previous total knee replacement. The purpose of this study is to present data of a group of patients undergoing angiography and embolization for recurrent hemarthrosis of the knee. Patient characteristics, angiographic findings, safety and efficacy of the procedure are reported.

A retrospective single centre review of patients undergoing angiography and embolization at a tertiary referral centre in Sydney, Australia from March 2006 to April 2018 was performed. A total of 25 patients undergoing a total of 29 procedures were identified (20 female, 5 male; mean age 67), the majority of which (23/25, 92%) had a history of total knee arthroplasty. Embolization was performed in 28 of the 29 procedures (97%). The embolic agent used was either polyvinyl alcohol particles (23/28), gelatin foam (3/28), detachable microcoils (1/28) or a combination of particles and coils (1/28).

The most commonly identified dominant vascular abnormality was periarticular synovial hypervascularity (23/25, 92%). A pseudoaneurysm was demonstrated in two patients (8%). Technical success (elimination of angiographic abnormalities) was achieved in 27 of 29 procedures (93%). There were 6 episodes of recurrence (25%) following a single embolization procedure, three of which were managed successfully with repeat embolization. There were no complications relating to skin or periarticular ischemia.

Angiography and embolization is a safe and effective tool for the management of recurrent hemarthrosis of the knee following arthroplasty and should be considered first line treatment following failure of conservative management.

Level 4, Case Series.

Level 4, Case Series.

In ballistic testing and forensic reconstruction, there is a need to use repeatable and consistent simulants. While synthetic bone is mechanically similar to human bone, it does not have the same viscoelastic properties. In high-energy impact such as ballistic impacts, bone acts as a stiff, brittle material and fails instantaneously. Therefore, a suitable simulant for use in ballistic testing should have comparable energy deposition to mammalian bones. This preliminary study aims to determine if Synbone® could be a viable proxy for Sus scrofa (domesticus) ribs in ballistic testing.

Three thickness of Synbone® were embedded into 10% ballistic gelatin and shot using 5.56-mm ammunition. The models were then analysed to compare the Synbone® to a previous Sus scrofa (domesticus) rib study and focused on the number of fragments within the block, energy deposition, onset of yaw, angle of deviation, the temporary cavity as a percentage of the block and the depth to the temporary cavity centre, depth to maximum gelatin disruption and the permanent wound channel, including shear planes and wound tract diameter.