PHARMA LITERATI

A collection of articles on complex biotherapeutic characterization and comparability  This collection of articles penned by some of the thought leaders in biotherapeutic characterization addresses several challenges faced by scientists in today's complicated world of biologics characterization, comparability, and host cell protein analysis. From intact mass analysis and complex drug-to-antibody ratio determination, to disulfide bond mapping and glycosylation tracking. This compendium offers you the ability to address your challenges in biotherapeutic characterization, highlighting cutting edge techniques for host cell protein quantitation, and explores automated solutions for determining biologics comparability. http://sciex.com/characterization-compendium?utm_source=linkedinad&utm_medium=social&utm_campaign=global_1q16_characterizationcompendium&utm_content=sponsoredupdate

A recent article in Pharmaceutical Patent Analyst highlights the growing interest of intellectual property in University setups. Authored by Aristotele Karytinos of Università Degli Studi di Pavia, Italy, the article is freely available and can be accessed at:   http://www.future-science.com/doi/pdf/10.4155/ppa.14.57   The role of innovation and IP focussed research in biopharmaceuticals industry is discussed. The importance of Technology Transfer Offices (TTOs) for the purpose of mediating the interaction between university, industry and the IP machinery is highlighted in the article.   In India, we rarely see this kind of arrangements with any of the so-called big pharmaceutical or biotechnology institutes. Request our readers to comment on the practices they are following in the universities regarding intellectual property and technology transfer. We would publish the comments on the blog.   Team Pharma Literati.     ...

A recent article on “Self-assembled sorbitol-derived supramolecular hydrogels for the controlled encapsulation and release of active pharmaceutical ingredients”, reveals how a self-assembling hydrogel with nanofibres that specifically capture and release anti-inflammatory compounds has been created for applications in targeted drug delivery. The drug naproxen is only unleashed from the gel in basic solvents, a trait that could be exploited to avoid naproxen’s undesirable side effects. The hydrogel, devised by David Smith and coworkers at the University of York, UK , could form the basis of a naproxen formulation that only dispenses the drug under alkaline conditions, such as those found in the small intestine. ‘Preparing the system is extremely simple,’ says Smith. ‘You mix the gelator and drug in water, treat with ultrasound, heat and then cool to form the gel.’ He adds that ‘the nanoscale structuring of the gel fibres means that they have a large surface area, and can ther...

Gowree Gokhale and Milind Antani of Nishith Desai Associates India discuss the issues & concerns in conducting clinical trials in India from a legal viewpoint.   http://www.pharmafocusasia.com/clinical-trails/issues-concerns-conducting-clinical-trials   Issues like approval delays, deficiencies of functioning of CROs and other stake holders, liabilities and compensation to injured subjects, insurance issues etc still remain in India, which has made multinational companies to rethink on opting for India to conduct clinical trials in India recently. There is a need for a law to ensure that the people who undergo clinical trials are not exploited and should be well informed about risk as well to provide clarity on regulations.   Summary:   1. Regulatory concerns: Although  regulations relating to clinical trials have evolved considerably to match global standards, many issues still remain. There are several grey areas in the regulations tha...

Subhadra Dravida, Founder and CEO of Tran-Scell Biologics& TranSTox BioApplications India and Prabhat Arya, Department of Organic and Medicinal Chemistry Dr. Reddy's Institute of Life Sciences (DRILS) University of Hyderabad Campus India write about the rethinking drug discovery. For full article, please visit: http://www.pharmafocusasia.com/research-developement/rethinking-drug-discovery     Drug discovery is a tough business! At the same time, it is the domain that provides an opportunity to improve the quality of human health and allows recovering from the suffering due to various biological disorders. In the past decades, we have witnessed a major limitation in creating the next-generation drugs despite a significant boost in the financial spending for research and development.   Summary As we have seen for the past several years, the current practice of drug discovery seems to be a losing battle and not much has come out to benefit the society th...

Narendra Kumar, Assistant Professor Department of Pharmaceutical Analysis National Institute of Pharmaceutical Education& Research Hyderabad, India writes about the application of Quality by design (QbD) principles to the development of analytical methods.   For the full articles, please visit: http://www.pharmafocusasia.com/information-technology/quality-design   Summary: The article highlights the application of Quality by Design principles to the analytical (HPLC) method development process. A marriage of HPLC with QbD is suggested for rapid and robust method development, understanding factors influencing chromatography, easier transfer of the method through proper documentation. The use of various modelling software programmes allowed a limited amount of experimental data to be used to examine a large number of probable run conditions. Once the optimum run conditions and their tolerance to change were predicted, experiments were run to confirm the predict...