The Evolution of Monoclonal Gammopathy of Undetermined Significance in Kidney Transplant Recipients.

It is unclear if immunosuppression increases the likelihood of malignant transformation of monoclonal gammopathy of undetermined significance (MGUS) and whether adverse renal outcomes in kidney transplant recipients with MGUS are more frequent. METHODS: We performed a retrospective cohort study of kidney transplant recipients at the Centre Hospitalier de l'Université de Montréal between 2000 and 2016. RESULTS: Among 755 study participants, 13 (1.7%) were found to have MGUS before transplant. Two evolved to smoldering multiple myeloma and 2 presented paraprotein-induced allograft injury from light chain deposition disease. Forty-six patients developed posttransplant MGUS (2.5% 5-y cumulative incidence) of which 1 progressed to multiple myeloma and 1 experienced kidney allograft loss from light chain deposition disease. None of the patients with a malignant transformation or paraprotein-induced renal disease after transplantation had had a systematic workup before transplantation to exclude hematologic malignancies and paraprotein-related kidney injury. Nine posttransplant MGUS (21%) were transient. Multivariable analysis revealed that age at transplant (hazard ratio 1.05 per 1-y increase, 95% confidence intervals, 1.02-1.08) and prior cytomegalovirus infection (hazard ratio 2.22, 95% confidence intervals, 1.07-4.58) were associated with the development of MGUS after transplantation. Of 7 posttransplant lymphoproliferative disorders, none were preceded by MGUS. CONCLUSIONS: Our results suggest that the identification of MGUS in a transplant candidate should lead to further investigations to exclude a plasma cell neoplasm and monoclonal gammopathy of renal significance before transplantation. MGUS arising after transplantation appears to carry a favorable evolution.

Physiology and behavior of dogs during air transport.

Twenty-four beagles were used to measure physiological and behavioral reactions to air transport. Each of 3 groups of 4 sedated (with 0.5 mg/kg body weight of acepromazine maleate) and 4 non-sedated (control) dogs was flown on a separate flight between Montreal, Quebec, and Toronto, Ontario, after being transported by road from Quebec City to Montreal. Saliva and blood samples were taken before ground and air transport and after air transport. The heart rate was monitored during the whole experiment except during ground transport, and behavior was monitored by video during air transport. Sedation did not affect any of the variables measured. The mean plasma cortisol concentration was significantly higher (P < 0.05) after ground transport than at baseline (225.3 vs 134.5 nmol/L); the mean salivary cortisol concentration was significantly higher (P < 0.05) after both ground and air transport than at baseline (16.2 and 14.8, respectively, vs 12.6 nmol/L). The mean neutrophil count was significantly higher (P < 0.05) after both ground and air transport than at baseline (80.6 and 81.4, respectively, vs 69.5 per 100 white blood cells), whereas the mean lymphocyte count was significantly lower (P < 0.05) (13.2 and 13.7, respectively, vs 22.4 per 100 white blood cells). Loading and unloading procedures caused the largest increase in heart rate. On average, the dogs spent more than 50% of the time lying down, and they remained inactive for approximately 75% of the time, except during take-off. These results suggest that transportation is stressful for dogs and that sedation with acepromazine, at the dosage and timing used, does not affect the physiological and behavioral stress responses of dogs to air transport.

Improvement in fresh fruit and vegetable logistics quality: berry logistics field studies.

Shelf life of fresh fruits and vegetables is greatly influenced by environmental conditions. Increasing temperature usually results in accelerated loss of quality and shelf-life reduction, which is not physically visible until too late in the supply chain to adjust logistics to match shelf life. A blackberry study showed that temperatures inside pallets varied significantly and 57% of the berries arriving at the packinghouse did not have enough remaining shelf life for the longest supply routes. Yet, the advanced shelf-life loss was not physically visible. Some of those pallets would be sent on longer supply routes than necessary, creating avoidable waste. Other studies showed that variable pre-cooling at the centre of pallets resulted in physically invisible uneven shelf life. We have shown that using simple temperature measurements much waste can be avoided using 'first expiring first out'. Results from our studies showed that shelf-life prediction should not be based on a single quality factor as, depending on the temperature history, the quality attribute that limits shelf life may vary. Finally, methods to use air temperature to predict product temperature for highest shelf-life prediction accuracy in the absence of individual sensors for each monitored product have been developed. Our results show a significant reduction of up to 98% in the root-mean-square-error difference between the product temperature and air temperature when advanced estimation methods are used.

Effects of radio frequency identification-related radiation on in vitro biologics.

The recent developments on the use of e-pedigree to identify the chain of custody of drugs suggests the use of advanced track and trace technologies such as two-dimensional barcodes and radio frequency identification (RFID) tags. RFID technology is used mainly for valuable commodities such as pharmaceutical products while incorporating additional functionalities like monitoring environmental variables to ensure product safety and quality. In its guidance for the use of RFID technologies for drugs (Compliance Policy Guide Section 400.210), the Food and Drug Administration outlined multiple parameters that would apply to any study or application using RFID. However, drugs approved under a Biologics License Application or protein drugs covered by a New Drug Application were excluded mainly due to concerns about the effects of radio frequency radiation (thermal and/or non-thermal) on biologics. Even though the thermal effects of radio frequency on biologics are relatively well understood, there are few studies in the literature about the non-thermal effects of radio frequency with regards to the protein structure integrity. In this paper, we analyze the non-thermal effects of radio frequency radiation by exposing a wide variety of biologics including biopharmaceuticals with vaccines, hormones, and immunoglobulins, as well as cellular blood products such as red blood cells and whole blood-derived platelets as well as fresh frozen plasma. In order to represent the majority of the frequency spectrum used in RFID applications, five different frequencies (13.56 MHz, 433 MHz, 868 MHz, 915 MHz, and 2.4 GHz) are used to account for the most commonly used international frequency bands for RFID. With the help of specialized radio frequency signal-generating hardware, magnetic and electromagnetic fields are created around the exposed products with power levels greater than Federal Communications Commission-regulated limits. The in vitro test results on more than 100 biopharmaceutical products from eight major pharmaceutical companies as well, as different blood products, show no non-thermal effect by radio frequency radiation. LAY ABSTRACT: Forthcoming requirements, such as the California Board of Pharmacy Track and Trace initiative regarding the use of e-pedigree to identify the chain of custody of drugs, suggest the use of advanced track and trace technologies such as two-dimensional barcodes and radio frequency identification (RFID) tags. When used for pharmaceuticals, RFID technology can support additional functionalities like monitoring temperature to ensure product safety. In its guidance for the use of RFID technologies for drugs, the Food and Drug Administration outlined multiple parameters that would apply to pilot studies using RFID while excluding drugs approved under a Biologics License Application or protein drugs covered by a New Drug Application due to concerns about the effects of radio frequency radiation on biologics. Even though the effects of radio frequency on biologics due to temperature changes are relatively well understood, there are few studies in the literature about other effects of radio frequency that can occur without a noticeable change in temperature. In this paper, we expose a wide variety of biologics including biopharmaceuticals to radio frequency radiation at different frequencies, as well as cellular blood products and plasma to high frequency radiation. The in vitro test results show no detectable effect due to radio frequency radiation.