Archives April 2011

US Marshals, at the request of the US Food and Drug Administration (FDA), recently seized more than $6 million in products distributed by Triad   Group, Inc, at the company's facility in Hartland, Wis. Triad Group and H & P Industries are owned and managed by the same parties. Several drug products were seized, which included povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, haemorrhoidal wipes, in-process drugproducts and raw materials. The action was taken due to the continued failure of Triad Group and H & P Industries to comply with the FDA's current Good Manufacturing Practice (cGMP) regulations, which are   intended to assure the safety, quality and purity of manufactured drugs. Through this seizure, FDA seeks to prevent the company from distributing products that were manufactured in violation of federally mandated manufacturing requirements. Dara Corrigan, Associate Commissioner for Regulatory more...

454 Life Sciences, a Roche company,  and NuGEN Technologies, have recently announced the development of a unique  sample preparation method and high-throughput sequencing solution for small   and degraded RNA samples. The collaboration leverages 454 Life Sciences' capabilities to construct sequencing-ready cDNA libraries from RNA samples and NuGEN's experience and innovation with genomic sample preparation solutions. This collaborative effort provides researchers an end-to- end solution for transcriptome profiling using their most precious sample types. "NuGEN's innovative sample preparation solutions provide a unique and powerful tool that will enable researchers to obtain    high-quality data from their less abundant samples. Together with 454 sequencing: Systems, the research community can perform whole transcriptome profiling on samples with as little as 500 pg of total RNA. Being able to collaborate with a leading NGS platform provider such as Roche, enables customers to leverage NuGEN's linear amplification technology while obtaining long and highly accurate sequence reads," more...

Waters Corporation has introduced its Waters9 Biopharmaceutical System solution. The new biopharmaceutical system brings together UPLC®/MS characterization technology with UNIFI™     Scientific comprehensive software biotherapeutic analyses high-resolution analytics across the development process continuum. The combination of Ultra Performance Liquid Chromatography (UPLC®), mass spectrometry and bioinformatics technologies results in efficient flow of data and information. It also conforms to biopharmaceutical quality guidelines and regulations. Focused on task-specific workflow design, the Biopharmaceutical System features automated data processing and simplified results validation. Leveraging UNIFI's architecture, the intuitive user interface can be configured for the roles and   capabilities   of   the   scientists throughout an organization. Critical to biopharmaceutical organizations is reliance on an analytical system that supports Good Manufacturing Practice (GMP) and compliance tools all with underlying secure database technology.

...says Rakesh Aggarwal, Director - Operations, Cole-Parmer, India. Explaining the business model, he discusses the strategies planned to achieve growth in the next few years in the life sciences segment. Meghna Mukherjee & Arshia Khan   How is your business performing? We are a knowledge and solutions- based business and deal with most of the industries in the scientific and process community. The premier channel through which we reach customers to offer our wide portfolio of products is our product catalog and website. We have an India-specific catalog, which contains more than 2,600 products and a biennial general product catalog with more than 10,000 new products listed. In India, we have a strong field sales and service team, which covers the length and breadth of the country and reaches customers with our value-added solutions. We also have a dedicated applications team based in  Mumbai, which provides exceptional technical support and customized solutions, assists in more...

Development of a new drug/molecule begins with a lot of ideas and interest and then it enters the long dark tunnel of risks and uncertainties. Pharma companies invest enormous amount of money and time for the development of a drug and bringing it into the market, but it is not without proper risk analysis and assessments that they do so. In most industries around the world, risk analysis and decision- making tools arc relevant. In times of recession, patent products expiration, lack of novel technologically advanced skills, pharma companies are relying on sophisticated specialization for analyzing the risks and uncertainties prevalent in the market. This will not only help them achieve their desired targets but will also ensure   or   predict the huge stumble or roadblock that their product might face in the long run. By necessity, experts in the Held garnering varied solutions are preferred, and    Protivitri    is more...

While much effort is spent in optimizing commercially operating plant, getting the process 'right first time' can be far more efficient. Real-time analysis of process parameters provides substantial support during development, streamlining and accelerating the evolution of successful process designs. A case study for investing in real-time process measurement for pilot studies is discussed. Real-time process analysis systems      are      used increasingly   within   the manufacturing environment. Automating   analysis   dramatically reduces    operational    variability and its associated inefficiencies- Automation can pay big dividends by improving product quality and at the same cutting the cost of production. These   savings   quickly   offset installation   costs,   strengthening the economic argument in favour of investment. The financial case for automation at the pilot scale may be less easy to make. Here, potential   benefits are not so immediately obvious,   and   can   be difficult to quantify, but are nonetheless   considerable. The   scope   for   more consistent operation, and the more...

The recent launch of version 7.0 of Argus Safety database application, by Oracle Software shows how Information Technology (IT) has become a crucial part of the healthcare system worldwide. This new updated version is a cloud-based product that allows healthcare firms to report and manage data from adverse drug events. This updated version will help healthcare companies keep a track of the adverse effects of drugs and will also help in efficiently running clinical trials. Oracle also has other software like Clinical, Remote Data Capture and Thesaurus Management System, but how many of them are being used in India? "In India use of specialized software like Argus is very rare. Unlike the US Food and Drug Association (FDA), in India too much emphasis or stress is not given to organized documentation of database. There are hardly any drug safety audits done in India and since no one asks for documentation more...