A clinical trials system developed for Vertex Pharmaceuticals has become publically available on the Biopharmaceutical Network http://www.biopharmnet.com/innovation/trial_simulation/cts1.php. The system is a SAS/AF® based interface in which clinical trials’ simulation parameters can be entered; it can operate either on a SAS grid or as a stand-alone process. The statistical details are publishe...

In the past few years, therapeutic microRNA (miRNA) and small interfering RNA (siRNA) are some of the most important biopharmaceuticals that are in commercial space as future medicines. This review summarizes the patents of miRNA- and siRNA-based new drugs, and also provides a snapshot about significant biopharmaceutical companies that are investing for the therapeutic development of miRNA and ...

The growing knowledge on the mechanisms of gene silencing and gene regulation by non-coding RNAs (ncRNA), mainly small interfering RNA (siRNA) and microRNA (miRNA), is providing a significant boost to the development of new therapeutic strategies for the treatment of cancer. However, the design of RNA-based therapeutics is hampered by biopharmaceutical issues, thus requiring the use of suitable...

Selection of mammalian high-producer cell lines remains a major challenge for the biopharmaceutical manufacturing industry. Ribosomal RNA (rRNA) genes encode the major component of the ribosome but many rRNA gene copies are not transcribed due to epigenetic silencing by the nucleolar remodelling complex (NoRC) [6], which may limit the cell's full production capacity. Here we show that the knock...

Non-linear optics encompasses a range of optical phenomena, including two- and three-photon fluorescence, second harmonic generation (SHG), sum frequency generation (SFG), difference frequency generation (DFG), third harmonic generation (THG), coherent anti-Stokes Raman scattering (CARS), and stimulated Raman scattering (SRS). The combined advantages of using these phenomena for imaging complex...

130 protein-based therapeutics are licensed today. With the addition of anticipated new biotherapeutics, the market is forecasted to exceed $140 billion USD in 2017. These therapeutic drugs have changed and improved the quality of life of millions of people around the world in the past few decades. One of the most important quality attributes of a biopharmaceutical drug is its heterogeneity, wh...

IN T RO DU C T IO N Correct protein conformation is essential for proper biological function of protein therapeutics. Changes in protein conformation are a major concern in the biopharmaceutical industry and conformational characterization is a difficult task. Many analytical tools such as circular dichroism (CD), differential scanning calorimetry (DSC), and analytical ultracentrifugation (AUC)...

systems play an essential role in today’s biopharmaceutical processes. Recombinant E. coli and yeast systems are dominant tools in early discovery of effective medical targets. These systems are also routinely used to produce biological reagents for analytical methods in research and quality controls of products. In the biopharmaceutical industry, microbial systems have delivered major medicine...