bacteriophages are well known in the biopharmaceutical industry, mainly due to their destructive impact on productivity of bacterialbased fermentations necessary for obtaining the product. however, it seems that their positive role may soon dominate their rather grim reputation in the biopharmaceutical industry. in this short editorial the reasons for the failure to fulfill the high hopes that ...

Pharmaceutical industry is showing a positive approach towards Quality by Design (QbD) for discovery, development, and commercial manufacturing of biopharmaceutical products. Regulatory agencies are providing various guidelines for pharmaceutical industry to build quality, safety and efficacy into their new biopharmaceutical products. Such concept became known as Quality by Design. To assess th...

Polysorbates (PS) are added to biopharmaceutical formulations stabilize proteins and monoclonal antibodies (mAbs) prevent aggregation, denaturation, surface adsorption. Polysorbate analysis can be challenging because of their inherent complexity, polydispersity, presence in matrices containing high concentrations other excipients such as sugars, amino acids, salts, buffers. This instalment “Bio...

Mammalian expression systems, due to their capacity in post-translational modification, are preferred systems for biopharmaceutical protein production. Several recombinant protein systems have been introduced to the market, most of which are under clinical development. In spite of significant improvements such as cell line engineering, introducing novel expression methods, gene silencing and pr...

This white paper has been written to facilitate an open discussion of issues related to the design and analysis of thorough QT studies. The correct bibliographic citation for this paper is as follows: Dmitrienko А, Beasley C, Mitchell M. Design and Analysis of Thorough QT Studies. Biopharmaceutical Network. Report 2008-04-29. A free copy of the paper can be downloaded from Biopharmaceutical Net...

Biosimilars or ‘follow-on biologics’ are new biopharmaceutical agents that are ‘similar’ but not identical to a reference biopharmaceutical product. Biosimilars are considered ‘comparable’ to the reference product, but this does not ensure therapeutic equivalence. Inherent differences between biosimilars may produce dissimilarities in clinical efficacy, safety, and immunogenicity. Therefore acc...

Oral drug absorption is a process influenced by the physicochemical and biopharmaceutical properties of the drug and its inter-relationship with the gastrointestinal tract. Drug solubility, dissolution and permeability across intestinal barrier are the key parameters controlling absorption. This review provides an overview of the factors that affect drug absorption and the classification of a d...