A spray freeze dried micropellet based formulation proof-of-concept for a yellow fever vaccine candidate
The stability of live-attenuated viruses is very challenging due to thermal sensitivity; therefore, solid form is usually required (often freeze-dried products). Micropellet technology is a lyophilization technology that has the potential to provide greater flexibility in the presentation of a given vaccine particularly in multi-dose format or in combination of different vaccines. As a novel vaccine alternative process, this spray freeze-dried (SFD) micropellet technology was evaluated using as a model a yellow fever virus produced in Vero cells (vYF) …
Continous Monitoring of Shelf Lives of Materials by Application of Data Loggers With Implemented Kinetic Parameters
The evaluation of the shelf life of, for example, food, pharmaceutical materials, polymers, and energetic materials at room or daily climate fluctuation temperatures requires kinetic analysis in temperature ranges which are as similar as possible to those at which the products will be stored or transported in. A comparison of …
Biophysical virus particle specific characterization to sharpen the definition of virus stability
Vaccine thermostability is key to successful global immunization programs as it may have a significant impact on the continuous cold-chain maintenance logistics, as well as affect vaccine potency. Modern biological and biophysical techniques were combined to in-depth characterize the thermostability of a formulated rabies virus (RABV) in terms of …
Kinetic analysis of solids of the quasi-autocatalytic decomposition type: SADT determination of low-temperature polymorph of AIBN
Simulations of SADT values based on the heat balance of the system are presented for azobisisobutyronitrile (AIBN). These simulations used kinetic parameters obtained from heat flow calorimetry experiments performed at temperatures in the stability range of low-temperature (L-T) polymorph of AIBN. Thermal Activity Monitor (TAM) data were collected in the range of 55-70 °C. The simulated SADT value for L-T AIBN amounts to 46 °C. This is very similar to the computed results obtained in the BAM project for the high-temperature (H-T) form of AIBN which amounts to 47 °C and is also in full agreement with the large scale experimentally found SADT of AIBN (47 °C) …
Accurate prediction of vaccine stability under real storage conditions and during temperature excursions
Due to their thermosensitivity, most vaccines must be kept refrigerated from production to use. To successfully carry out global immunization programs, ensuring the stability of vaccines is crucial. In this context, two important issues are critical, namely: (i) predicting vaccine stability and (ii) preventing product damage due to excessive temperature excursions outside of the recommended storage conditions (cold chain break) …
SML 6 Software – General Presentation
Employing advanced numerical algorithms, migration modelling with the SML software [1] allows prediction of the amount of organic migrant (like residual monomers, additives, contaminants, reaction products, non-intentionally added substances from plastic multi-layer or multi-material multi-layer materials) which migrate into the packed food or other contact media like pharmaceuticals, cosmetics, drinking water or environment. The application of the software insures the compliance of plastic food contact materials and articles with specific migration limits according to EU Regulations [2, 3] and Swiss Legislation [4] …
Probabilistic migration modelling focused on functional barrier efficiency and low migration concepts in support of risk assessment
Migration modelling provides reliable migration estimates from food-contact materials (FCM) to food or food simulants based on mass-transfer parameters like diffusion and partition coefficients related to individual materials. In most cases, mass-transfer parameters are not readily available from the literature and for this reason are estimated with a given uncertainty. Historically, uncertainty was accounted for by introducing upper limit concepts first, turning out to be of limited applicability due to highly overestimated migration results …
Thermal decomposition of AIBN, Part B: Simulation of SADT value based on DSC results and large scale tests according to conventional and new kinetic merging approach
The paper presents the results of the common project performed with the Federal Institute for Materials Research and Testing, Berlin, Germany (BAM) concerning the comparison of the experimental results with simulations based on the application of the kinetic-based method and heat balance of the system for the determination of the self accelerating decomposition temperature (SADT). The substantial potential of the kinetic-based method is illustrated by the results of the simulation of SADT of azobisisobutyronitrile (AIBN) …
Determination of Thermal Hazard from DSC measurements. Investigation of Self-Accelerating Decomposition Temperature (SADT) of AIBN
The method of determination of the thermal hazard properties of reactive chemicals from DSC experiments is illustrated by the results of SADT simulations performed with azobisisobutyronitrile (AIBN). The kinetics of decomposition of AIBN in the solid state was investigated in a narrow temperature window of 72-94 °C, just below the sample melting. The kinetic parameters of the decomposition were evaluated by differential isoconversional method. The very good fit of the experimental results by the simulation curves, based on the determined kinetic parameters, indicated the correctness of the kinetic description of the process …
ICTAC Kinetics Committee Recommendations for Collecting Experimental Thermal Analysis Data for Kinetic Computations
The present recommendations have been developed by the Kinetics Committee of the International Confederation for Thermal Analysis and Calorimetry (ICTAC). The recommendations offer guidance for obtaining kinetic data that are adequate to the actual kinetics of various processes, including thermal decomposition of inorganic solids; thermal and thermo-oxidative degradation of polymers and organics; reactions of solids with gases; polymerization and crosslinking; crystallization of polymers and inorganics; hazardous processes …