Tag Archives: consequences

  • Risks in Lean Compliance

    … potential risks in lean biomanufacturing, one must follow these steps in order to be successful in your research: be proactive to assess probability and potential consequences, take action to reduce the probability of unfavorable consequences, use tools to try your best to predict likely problems and make sure to take predetermined measures/actions to minimize problems, should anything arise! It’s simple, to the point, and you may be telling yourself, “Hey, I knew that all along!” It never …

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    … global market where cost, time to market and short cycle times play such a critical role in the success of a product. However, with that being said, the focus on product quality has at least as much an impact on success because this is so tightly bound with product safety and the eventual successful deployment of the product as a medicinal agent. The social responsibility associated with making a safe medical product is extremely important as the consequences of a defect are connected to the …

  • The Right Sequence for Lean Manufacturing Implementation

    … production in the outsourcing country. Is this really the best solution?  Wouldn’t it be better to apply lean manufacturing solutions, eliminate waste, continuously strive for more efficient production processes, and become more responsive to customer demand? Due to the compartmentalized nature of departments within the pharmaceutical industry there exists a separation between manufacturing and R&D – a separation that has had far-reaching consequences, the weight of which are …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    … understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason. This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the blood cell system, …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    … If scientists understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason. This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the …

  • Growing Cooperation between Big Pharma and Patients

    … pharmaceutical companies are primarily concerned with only getting to the sale, instead of any consequences that may be the end result from the sale.  Many patients feel that far too much emphasis is being placed on making the sale, and making the profit at any means necessary, while not having the patients’ overall wellbeing as their primary concern. Many patients’ rights activists feel that pharmaceutical companies need to place greater emphasis on supporting what happens after a …

  • Failing an FDA Inspection

    … problems to your company in the event of an inspection failure.  Here are some consequences your company might face if you fail your FDA Inspection. One severe consequence of this is that the news will very likely become public, which could damage your reputation as a company.  This may result in a loss of consumer confidence, your stock prices could very well go down, and your business partners and investors may lose faith in your company.  This could result in millions of lost investment, …

  • The Future of Influenza Vaccine Design

    … certain age groups, for example, kids 6 months to 9 years of age, with evidence of a massive reduction in secondary bacterial infections causing otitis media. The more live influenza virus vaccines are used, the more benefits, risks, and economic consequences of this approach will be known. 2.    Genetically engineered live influenza virus vaccines The introduction of techniques to engineer site-specific changes in the genomes of negative-strand RNA viruses has allowed the consideration of …

  • Dishonest Marketing in Pharmaceuticals Demands a Big Price to Pay

    … researchers concentrate in finding ways to increase shareholder value instead of thinking about the consequences of dishonest marketing, which could end up costing much more.  Instead of focusing on value creation, this study evaluates marketing from a value destruction point of view. The study states that pharmaceutical companies have been spending money on promotion at an annual growth rate of 10.6% since 1996, reaching $3 billion in 2005, and that since 1997, when the FDA allowed for direct …

  • The Tremendous Value of a Virtual Organization

    … –    Impartiality A virtual organization works under the premise that all its clients are equally valuable.  Every time a possibility of partiality emerges, the clients should be informed about it and its consequences. –    Communication The philosophy is of constant, clear, open, and friendly communication all the time.  In order to be successful, virtual organizations require modern information technology systems 24/7. In order to be able to survive and excel under the new …

  • FDA Regulations

    … experienced consulting firm, your company may fail to take the preventive actions necessary to successfully pass an FDA audit.  Because of the severity of the consequences in developing possible faulty pharmaceutical products, the FDA has very little tolerance for variability or deviation from its quality inspection regulations.  This means if your products do not pass this FDA quality inspection, you will be shut down, and shut down fast. The pharmaceutical industry, like any traditional …

  • Selection Of Expression Systems In Recombinant Protein Production

    … consequences on the efficacy of the target recombinants down the line. Bacterial systems are considered ideal because of their low cost, high productivity and ease of use compared with mammalian systems. The lower risk of contamination due to viruses and other agents which can be present in, for instance, mammalian systems, is a regulatory and safety benefit. However, bacterial production cannot yield an effective product because of the requirement for post-translational modifications such as  …