Tag Archives: methods

  • Waste Removal

    … as “low hanging fruit” components. Before going ahead and investing major time and effort into complex waste removal practices start with the materials that can most obviously be considered waste. Although this seems logical, many would be surprised at how many researchers overlook this step in lean biomanufacturing and instead strategize complex methods for removing harder to eliminate waste. Don’t fall victim to this practice. Don’t overlook the obvious. The effort to remove the most …

  • Value Stream Mapping

    … over their heads with all of the new methodologies and research findings that enter into the market. Utilizing research methods that yield the best results for your company is a major key to success in this industry. Meet value stream mapping. Isn’t it nice to think of anything in life in its Ideal State? In lean biomanufacturing it’s vital to identify the Ideal State of your process in order to truly hone in on your overall envisioning for your design. After all, a seamstress …

  • Flow Charting

    … developing in a very systematic manner, involving products and processes that were initially defined by R&D-based bench scientists. The cost constraints involved when developing pharmaceutical and biopharmaceutical products are significant, which is why final methods, ideals for development and production are not established until there is some sort of understanding, or rather proof, that the material in question will be an effective medical product. Here is a list of the basic operating …

  • Fishbone Analysis

    Understanding the Basics of Fishbone Analysis Lean Biomanufacturing, Dr. Nigel J. Smart Tackling the demands of the biopharmaceutical industry can prove to be quite trying in today’s competitive field. Yet with proper research and experimentation, companies can readily understand the kinks in their systematic methods early on, leading to great success in their research. Tools like fishbone analysis can ultimately help yield accurate results and benefit researchers in the long term within their …

  • Leachables and Extractables in Biopharmaceutical Processing

    … there’s any regulatory impact, particularly as it relates to safety. Although issues connected with Leachables and Extractables has been discussed for over 25 years, the recent trend towards the use of new disposable methods of production which includes; wave bags, disposable plastic bioreactor inserts and their myriad of associated tubing and samplers, means that the probability of some elastomer eluting from the components or alternatively some breakdown product washing off the material …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    When market conditions, and methods of manufacturing, testing, and technology remain virtually unchanged for long periods, companies within that industry generally manage quite well doing everything in-house. However, when an industry finds itself in the throes of rapid and unexpected change, outside experts are often needed to provide the knowledge and expertise necessary for corporate survival. That is exactly where the pharmaceutical industry is, and why the value of pharmaceutical …

  • 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 …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … and then determines the steps and methods necessary to get you from here to there. Selecting just the right consulting firm for your company and your needs involves not so much examining what the consultants can do, but how they do it. Below are 7 key considerations to choosing the right pharmaceutical consultant. 1. Honesty Now this may seem painfully obvious, but it is something you just can’t afford to overlook. Consulting firms generally offer a broad range of services, and some have …

  • Making Relationships Count With Life Sciences Consulting

    … methods are often the same methods used 10 or 20 years ago. Consequently, this strategy very often falls short of achieving the maximum potential value for life sciences companies. Initially, the CMO-sponsor relationship was entered into chiefly as a tactical, specific solution. Later, owing mostly to quality issues that began to crop up, central governance was created. And more recently, in the effort to build global networks, emphasis has been on the supply chain. The dynamics between CMO and …

  • Microbiology: Transcending Waste With Lean Manufacturing

    … manufacturing along with its neglect of certain areas, especially quality assurance and microbial contamination testing, when implementing lean principles. Since most drug manufacturers use outdated and inefficient testing methods, this area is in critical need of waste and process-time reductions. Because standard testing methods require a minimum of three to seven days to yield results, during this period of product quarantine and testing resources are wasted instead of contributing to …

  • The Future of Regenerative Medicine

    … bioengineers picture a material system in which the embedded cells emit a signal so that deeper cells form bone white cells close to the surface form cartilage. Regenerative medicine anticipates several things: -A rising impact of cell-based therapies in clinical medicine -methods that make it easy to regenerate skin, bone, cartilage, bladder, and trachea from bone marrow stem cells, and also the regeneration of blood vessels and heart valves -The restoration of function in complex tissues like …