Articles

The US economy has been experiencing one of the severest job crunches in the last decade. Advancement of technology to replace low skilled jobs as well as productivity improvement to remove the fluff has been driving job displacements. Offshoring has actually been a marginal driver for the increasing job losses in the US. As a matter of fact, job losses in the US over the last 3 to 4 years have not exactly resulted in a comparable offshore job creation. Read more

Although there has been relatively more focus on CROs performing clinical trials in emerging markets, CMO activity is continually increasing in these regions with a bulk of the global API supply now being manufactured in China and India. Legitimate concerns have been raised about the globalization of biomedical and pharmaceutical manufacturing operations. Read more

Continuous manufacturing is gaining ground in the pharmaceutical industry. In the current economic climate many organisations are looking to make their manufacturing more cost effective and reduce inefficiencies with lean processes. Read more

The principles of quality and efficiency in pharmaceutical manufacturing have arguably never been more important. For companies facing increasing competition from generics, everyday counts when it comes to getting a new drug to market, as does maintaining high standards and compliance. Read more

The study found that choosing the right equipment in the first place is a primary concern for 42.9 per cent of users. Understanding the limitations of disposable equipment was shown to be a major headache for 35.7 per cent, while internal expertise was an issue for 7.1 per cent. Read more

Experts predict that within five years, the global biologics market will exceed $239 billion (£145 billion) in value, but there are just a few critical areas that threaten to hold developers back. Mitigation of risks arising from the contamination of adventitious agents is one such area of which knowledge is distinctly limited. Read more

When the State Food and Drug Administration (SFDA) of China launched its new good manufacturing practice (GMP) guidelines in March 2011, it presented a list of new opportunities and challenges for what is to become the world's third largest pharmaceutical market by 2012. Read more

When asked by Pharma IQ to name the types of contaminant of most concern to their organisation, survey respondents gave mixed replies. One quarter of delegates said transmissible spongiform encephalopathies (TSEs), or prions, as well as their bovine siblings BSEs, were of most concern. Read more

Yet there is one area where the industry's knowledge is still limited; how to mitigate the risk or deal with contamination of adventitious agents. Read more

A recent Pharma IQ survey conducted with key members of the pharma and biopharma community revealed that, while 54.5 per cent of organisations outsource less than half of their global manufacturing, 18.2 per cent currently use outsourcing for at least 91 per cent of their output. These basic findings support a recent report by Global Industry Analysts (GIA), which predicted that the global pharmaceutical contract manufacturing market would reach a total value in excess of $40.7 billion (£24.4 billion) by 2015. Read more

During the past six years, single use systems and devices have emerged as a key change agent in the biomanufacturing landscape. Acceptance in R&D and scale-up has been driven by their effectiveness in reducing risks of contamination, faster changeovers, advantages over fixed stainless steel systems in cleaning and validation, and significantly reduced time, and costs to get a new facility up and running. Now, single use products have pushed beyond an early-stage technology, and are poised to emerge into the much larger, GMP commercial-scale operations. The emergence of single use devices onto the commercial stage is likely to create radical changes in the biomanufacturing landscape. Key to this is first to resolve safety issues associated with leachables and extractables. Comparability with existing processes (stainless steel) will result in more rapid adoption rates. Read more