Implementing the in vitro pyrogen test: one more step toward replacing animal experimentation.

Endotoxin Contamination of Large Volume Parenterals as Detected by Limulus Amebocyte Lysate as an Alternative to Rabbit Pyrogen Test

The possibility of replacing the rabbit pyrogen test by the Limulus Amebocyte lysate (LAL) test, as a final release test for Large Volume Parenterals (LVPs) was investigated. The sensitivity and specificity of the LAL test and rabbit pyrogen assay were studied by means of artificially contaminated parenterals. Various LVPs (mostly containing electrolytes) were spiked with 0.5 and 5 EUlml o...

In vitro pyrogen test for toxic or immunomodulatory drugs.

Pyrogenic contaminations of some classes of injectable drugs, e.g. toxic or immunomodulatory as well as false-positive drugs, represent a major risk which cannot yet be excluded due to the limitations of current tests. Here we describe a modification of the In vitro Pyrogen Test termed AWIPT (Adsorb, Wash, In vitro Pyrogen Test), which addresses this problem by introducing a pre-incubation step...

A Two -Step Modification toward Implementing Compressible Source Terms in Low Compressible Flows

Effects of Weaning Age on Growth and Blood Parameters of Replacing Holstein Calves Fed on a Restricted Step Up and Down Milk Feeding Program

The objective of this study was to investigate the effects of different early weaning programs on growth performance and blood parameters of dairy calves. To meet this objective, thirty Holstein calves with initial body weight of 36 ± 5 kg were randomly assigned at birth to one of the three weaning programs. Experimental groups were: 1) starter diet and whole milk from birth to 6 weeks and wean...

Safety testing of cell-based medicinal products: opportunities for the monocyte activation test for pyrogens.

The European Partnership for Alternative Approaches to Animal Testing (EPAA) pointed out the need to involve authorities throughout the process of validation and legal acceptance of alternatives to animal experiments. The Paul-Ehrlich-Institute (PEI), Federal Agency for Sera and Vaccines, is the national competent authority in Germany which is responsible for the quality and safety of biologica...