Tag Archives: impact

  • WHO Ebola Vaccine Meeting

    So what’s with all of the buzz on Ebola vaccines and how will it impact the future of this outbreak? The overwhelmingly and ever increasingly amount of buzz surrounding Ebola is undeniable. Although this is not a new concept or topic of discussion in the news room, there seems to be no letting up as the continuous circulation of news coverage wavers on.   News of a high-level World Health Organization (WHO) meeting was announced weeks ago and from that point the speculation and discussion …

  • Waste Removal

    Waste Removal Lean Biomanufacturing, Dr. Nigel J. Smart The million dollar question in lean biomanufacturing is (drum roll please)….how can we go about removing all of that waste? Although the process seems rather grueling, trust in the fact that waste removal is beneficial to your research. Waste removal will have a major impact on your team’s overall biomanufacturing goals. Yes, sometimes various components of your research cannot be eliminated. And if that is found to be true within your …

  • Kaizen Events

    Implementing Kaizen Events into Your Research Team’s Methodology Lean Biomanufacturing, Dr. Nigel J. Smart In lean biomanufacturing the term Kaizen events “refers to the impact of the outcome relative to the cost expended.” Much different than most constructive concepts, in a Kaizen event once the main event is complete, the researchers’ work is far from over.  In fact, their work has only just begun. These processes are quite complex and require strong attention to detail. A vital …

  • 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 Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … Lean consultant is well placed to provide objective feedback about the program to senior management and to maintain the commitment from senior management that is required in order to deliver lasting sustainable improvements to the business. This is by no means the extent of the benefits that can be delivered using a Lean consultant, but it does effectively highlight the diverse number of areas where they can have a meaningful impact. …

  • Leachables and Extractables in Biopharmaceutical Processing

    With the burgeoning interest in the use of disposables for the production of modern biopharmaceutical products, the level of scrutiny surrounding the topic of Leachables and Extractables has moved into a higher gear. It seems that there is an endless amount of attention being paid to this topic because of the potential impact on patients receiving biopharmaceutical based therapies. As a result there is a frantic level of regulatory activity as scientists attempt to predict and quantify whether …

  • Metrics and their Importance in Lean Biomanufacturing

    … inoculum preparation and work up can be appropriately synchronized to assure that the tanks are ready to be re-inoculated with the next batch once they have been cleaned and re-sterilized. This should be a key area of focus for both fully integrated companies that have their own facilities or CMO’s that provides manufacturing services for client companies. In either case, lost production time has an impact on both business models, although for CMO’s there may be a greater pressure because …

  • Eliminating Pharmaceutical Manufacturing Chaos through Implementation of an Effective 5S Program

    … often the result and inefficiency together with an increase in work related mistakes is the eventual outcome. Whatever the outcome you choose to define, the impact on the manufacturability is to affect at least one of the following: decreased finished goods productivity, increased cycle times, raised error frequency, increased waste production, increased accumulation of WIP (work in progress) and a disruption in workplace organization. All of the above contribute to an unsatisfactory situation …

  • Visual Factory Methodology to improve Lean Manufacturing in Life Science Product Companies

    When employing a Lean approach to pharmaceutical (Life Science) manufacturing, the implementation of a Visual Factory Methodology as part of the approach can have a very significant impact. The goal of Visual Factory implementation is to permit the very efficient transfer of information that can have a material effect on the performance of the manufacturing plant. Two parts are critical in implementing this:  – Deciding what the necessary information is that needs to be conveyed. …

  • Lean Enterprising; A term coming of age in the Implementation of Lean in the Life Science Industry

    As Lean manufacturing makes an increasingly bigger impact on pharmaceutical manufacturing and Life Science Product Companies in a wider sense, the terminology of Lean Enterprising is becoming more commonplace. Traditionally the focus has been to initiate Lean manufacturing and specifically the elements surrounding the shop floor production systems that impact this. However, today the emphasis is more on a general holistic implementation which covers the whole business “enterprise” network. …

  • Risk Management as part of your Lean Compliance Strategy to enable you to meet your Compliance Obligations.

    … Assessment Matrix can have a drammatic effect on this process which in turn has a material effect on the ROI for the plant. This is an example of how Risk Assessment as part of an n overall Lean Compliance Strategy can impact the competitiveness of a modern manufacturing process. Pharmaceutical constants that are knowledgeable in Lean Management and Compliance Risk Assessment are a good resource to help initiate these types of programs so you can reduce that burden immediately without …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    … from all sides, particularly through the impact of new technologies across the whole discovery and development process and from changes in the way that health care is funded and delivered.” The changes Peakman spoke of have progressed even further, and there are other, more radical changes than those he had in mind in 2000. Growing FDA intrusion and compliance burdens, a dwindling number of blockbuster drugs and looming patent expirations, slowing growth in the market and shrinking profit …