The costs of developing the types of new drugs that have been pursued by traditional pharmaceutical firms have been estimated in a number of studies. However, similar analyses have not been published on the costs of developing the types of molecules on which biotech firms have focused. This study represents a first attempt to get a sense for the magnitude of the R&D costs associated with the di...

Biological sample pretreatment is an important step in biological sample analysis. Due to the diversity of biological matrices, the analysis of target substances in these samples presents significant challenges to sample processing. To meet these emerging demands on biopharmaceutical analysis, this paper summarizes several new techniques of on-line biological sample processing: solid phase extr...

The aim of this study was to determine the biopharmaceutical characteristics of tobramycin (TOB) after nebulization in rats. TOB was administered by intravenous (i.v.) bolus or intratracheal nebulization (3 mg · kg(-1)), and concentrations were determined in plasma and epithelial lining fluid (ELF) by liquid chromatography-tandem mass spectrometry. The ratio of the TOB concentration in ELF to t...

The landscape of biopharmaceutical analysis features different analytical requirements in terms instrumentation and type (QC, RTRT, in-process). One the questions that often crops up for routine is “How much replication enough?” Should all samples be run triplicate irrespective analysis, or does (such as charge size variants) have any bearing on number optimal replicates?

The expression of recombinant proteins has increased in importance for both research and biopharmaceutical manufacturing applications. Chinese Hamster Ovary (CHO) cell lines are one of the most frequently used cell lines for the expression of recombinant proteins that require posttranslational modification to exhibit full biological function. CHO cells used for large-scale production of recombi...

There is a strong demand on the market for protein biopharmaceuticals that are formulated as liquids. They are easier for the physicians to handle and cheaper for the biopharmaceutical industry to produce as compared to lyophilisates, as no lyophilization step is needed. Optimally, the biopharmaceutical drug product (DP) should have a shelflife of at least two years. Recombinant proteins, howev...

Biopharmaceuticals are an integral part of modern medicine and pharmacy. Both, the development and the biotechnological production of biopharmaceuticals are highly cost-intensive and require suitable expression systems. In this review we discuss established and emerging tools for reengineering the methylotrophic yeast Pichia pastoris for biopharmaceutical production. Recent advancements of this...