The study aimed to combine two antidiabetic agents with different mechanisms of action, namely, metformin HCl and rosiglitazone maleate, in a tablet to improve glycemic control in patients with type II diabetes. The preformulation study started with development and validation of an HPLC method for the determination of both drugs in the mixture. The results of visual inspection, TLC, DSC, and FT...

Many of today’s drugs arise from bioprocesses including microbial, yeast and animal cell lines. These include small molecules such as antibiotics and the so-called biopharmaceutical (recombinant) proteins and gene therapeutics. Indeed, currently the biopharmaceutical market is estimated to grow by 20% per year compared with 7 to 8% for the overall drug market. The ability to control a bioproces...

This report highlights the drivers, challenges, and enablers of the hybrid modeling applications in biopharmaceutical industry. It is a summary of an expert panel discussion of European academics and industrialists with relevant scientific and engineering backgrounds. Hybrid modeling is viewed in its broader sense, namely as the integration of different knowledge sources in form of parametric a...

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...

Integrating political, industrial and healthcare systems has been a major challenge for politics of innovation and development policy in low and middle income countries. This challenge has so far been understood in terms of separate industrial and health related innovation policies without paying adequate attention to the institutional roles of biopharmaceutical and other umbrella associations....

Abstract Objective Random effects are often neglected when defining the control strategy for a biopharmaceutical process. In this article, we present case study that highlights importance of considering variance introduced by random in calculation proven acceptable ranges (PAR), which form basis strategy. Methods Linear mixed models were used to model relations between process parameters and cr...