Tag Archives: area

  • Fall Networking Event, a Success!

    … professionals in the West Chester area. Some of the attendees included representatives from Innovation Technology Action Group, renowned local artist, Motionista, DNB First Banking, JetPay Payroll Services, S.C. Blodgett & Co., Inc., Gallagher Consulting, IComm, SparkNET Technologies, and Fox Rothschild LLP…just to name a few. One of our lucky attendees even walked away with a gift card to Éclat Chocolate, gourmet chocolate by Christopher Curtin. We had a fantastic turn out of roughly …

  • Leachables and Extractables in Biopharmaceutical Processing

    … potential risk and then to subsequently ameliorate possible negative outcomes that are identified. This is a really important step and should be planned carefully as it can save a lot of effort if it’s completed according to a well defined approach. With the projected level of activity in using disposable production systems expected to increase markedly over the next 5-10 years, we can expect to see this area receive even more attention. Currently various industry associations are interfacing …

  • 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 …

  • Lean Manufacturing Solves Drug Recalls and Bad Press

    … talk about outsourcing off-shore, American jobs are being lost at an alarming rate in an area where there’s been traditional strength. Strategically, this is a problem for the US Pharmaceutical industry. Perhaps now’s the time for us to re-assert this strength? However, we’ll only be able to do that if we apply the appropriate techniques and methods in a logical and consistent fashion.” Fortunately, manufacturing is the one aspect of drug production most amenable to change …

  • The Right Sequence for Lean Manufacturing Implementation

    … not viewed by management as being a viable area for gaining a competitive edge.  Indeed, due to shrinking profit margins and increasing cost pressures, companies are increasingly outsourcing their production overseas where costs are lower.  Pharmaceutical executives are reducing the task of cutting costs to a simplistic equation, and outsourcing decisions are often made on nothing more than a comparison between the cost of production at the company’s facility versus the cost of …

  • Microbiology: Transcending Waste With Lean Manufacturing

    … assurance. Nevertheless, it remains a largely overlooked area when pharmaceutical manufacturers attempt a lean manufacturing implementation. Phil Emard, President of OpEx, Inc., makes the point that a full implementation of the lean manufacturing process can often bring about productivity gains of 30% and lead time reductions of 70% – the key word here being “full.” Historically, the biggest obstacles to a full implementation have been the compartmentalized nature of pharmaceutical …

  • Counteracting Expanding FDA Reporting Requirements Through Lean Manufacturing

    … the product. Flow will thus be improved in this area, and what were once viewed as non-value added activities will come to be seen as, and will in a sense become, value-added activities. And so waste is reduced and a process improved. With lean thinking applied to compliance and reporting, and a lean manufacturing system implemented for actual production, pharmaceutical companies can effectively counteract expanding FDA reporting requirements. The only other ingredient needed is qualified lean …

  • Pharmaceutical Consulting Firms: Hero or Hype?

    Pharmaceutical consultancy is emerging as a way for manufacturers to manage the increasing pressures of rising costs, heavier regulatory compliance, and stiffer competition. Although a relatively new area of expertise, pharmaceutical consultants are proving to be a valuable asset to both pharmaceutical manufacturers facing rising costs of R&D, production, and distribution, as well specialized healthcare services trying to control their own rising costs. Everyone is finding themselves in …

  • The Future of Regenerative Medicine

    … 250,000 knee replacements are done in a year. In this case, injecting a suspension of autologous cultured chondrocytes into the problem area won’t work effectively because the cells have the tendency of forming fibro cartilage and of losing their round shape. The best way to treat osteoarthritis of the knee is to embed the chondrocytes in the cartilaginous matrix that wears away just as the cartilage does. If the chondrocytes are enveloped in gels, this permits the cells to maintain their …

  • Innovative R&D Through Lean Manufacturing Principles

    … chains, and other aspects of the industry that involves formally standardized processes. When it comes to R&D, however, the perception is that application of principles developed in the auto industry – principles designed primarily to aid in the improvement of manufacturing line processes and project management – won’t really work and may even be a hindrance in an area that is inherently innovative and intellectual. What isn’t readily apparent, however, is the fact that …

  • The Drive Behind Lean Manufacturing Implementation

    For many years not a lot of thought was given to production and the supply chain within the pharmaceutical industry. As long as market demand was met with quality, compliant products, production was generally ignored as an area that could lend itself to gaining a competitive advantage, and things rocked along pretty much as they always had. Today the growing cost, along with compliance and competitive pressures, are changing that attitude and executives are increasingly looking to apply lean …