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Article Modular Manufacturing Platforms for Biologics
May 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 5 It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…

Article Drug Discovery and Development in India
…f a market’s attractiveness for innovative drug makers) compared to its Asian counterparts such as China and Indonesia (3). The low score is driven by the frequent threats to patents through compulso…

Article Bureaucratic Roadblocks Threaten Biopharma Growth
Furthermore, Brazil’s unprecedented review of patents by the health regulatory authority, China’s increased data requirements, and Canada’s increased utility requirements all ultimately undermine the …

Article Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility. The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…

Article Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The China Food and Drug Administration has also begun discussions on the development of a biosimilar approval process,” observes Santos da Silva. Each of these approval pathways is different, th…

Article Brazil Emerges as Global Biopharm Collaborator
By 2016, a year in which the country will host the Olympic Games, IMS estimates Brazil will occupy the fourth position, with an estimated growth between 1415%, only behind the US, China, and Japan and…

Article Drugs, At What Cost?
In emerging markets (more than 20 nations including China, Brazil, India, Russia, Mexico, and Turkey), growth will increase from $26 billion in 2012 to $30-50 billion in 2017, primarily due to increas…

Article Report from India
Pharma industry players brace for challenges as India’s new drug-pricing policy kicks in full gear. (Dmitry Rukhlenko/Getty Images) On July 1, India's new…

Article Milestones and Moderate Progress in 2012 Drug Approvals
Until 2012, no gene therapy-based product had gained approval for human use in the western world, although a small number of such products have been approved in China (5) and four gene therapy-based d…

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