Tag Archives: biopharmaceutical industry

  • Risks in Lean Compliance

    … risks is what truly gets people talking and from there brilliant ideas are drawn up. Now, in the biopharmaceutical industry going lean is all about taking risks and understanding that risk. So what about the 80:20 rule you may ask? What’s all of the fuss about in regards to identifying risk in lean compliance? Let’s try and wrap our brains around this concept a bit. “Risk is a balance of certainty and uncertainty, in addition to the probability of something occurring.” It’s vital to …

  • Flow Charting

    Getting to Know Flow Charting in Lean Biomanufacturing Lean Biomanufacturing, Dr. Nigel J. Smart When it comes to lean biomanufacturing, flow charting is deemed as one of the most basic techniques for defining what is required to operate a particular process. It is no question that the biopharmaceutical industry has evolved quite tremendously in recent years, and as we adapt to these changes, it’s vital to understand the progression in which the industry is transforming. The pharma industry is …

  • 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 …

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    By Nigel J Smart PhD, Smart Consulting Group To some, Lean Manufacturing is a meaningless concept when one is considering medical therapies or medical products. Often there is confusion in common English language, where the emphasis is on the Lean & Mean interpretation associated with just being efficient. As we all know this is a big misconception associated with our terminology and unless we pay attention then there is a real danger that we will miss the boat and create something that’s …

  • New Data on the Inspection of Human Cell & Tissue Products by the FDA

    A recent report charting inspectional information by the FDA for human cell/tissue therapeutic products shows a marked increase in inspection activity. The period covered is 2003-2010 and reports an increase in the number of inspections by about 250%, with an average duration of each inspection of 40-45 hours. During that period, voluntary compliance actions taken by companies as a result of inspections has increased 255% and official action taken has increased 240%. This is against a background …

  • Lean Approaches in Bioprocessing to Help Minimize Variability in Production Yields

    It’s probably no surprise to many skilled practitioners that one of the major lean initiatives in bioprocessing is to improve throughput and reduce cycle time. Apparently this is all very obvious but it’s really surprising how many manufacturing operations fall down over this relatively simple concept. AND this applies equally to both clinical production as well as commercial manufacturing. Very often there are points of failure in processes that are associated with variability at both the …

  • Critical factors in Filing NDC numbers with the FDA

    There are three essential factors that need to be considered when deciding whether a new NDC number needs to be filed for a product: 1. Whether the label is different 2. Whether the formulation is different 3. Whether the packaging is different If any of these three elements changes, then this will trigger the need for new NDC numbering codes for a given product. Simply put, if the same product formulation is put into several different packaging sizes then this will trigger a new number. If …

  • How a Pharmaceutical Consultant Can Improve Business Health

    No doubt, things are tough—and getting tougher—for the pharmaceutical industry today, especially for the smaller companies. They now have to buckle down and find ways to operate far more efficiently than in easier times. Every drop of value has to be squeezed out of every dollar invested in R&D, production, distribution, marketing, and sales. And this is where pharmaceutical consultants can help.

  • Considerations In The Manufacture Of Recombinant Drugs

    When it comes to recombinant protein drugs, the selection of the correct expression technology is of paramount importance. This is true from the first steps of development through clinical production to commercial manufacturing thereafter. This is so important because, the correct balance between time and cost against yield and quality is essential to maximize return on investment. Although the creation of a regulatory-compliant cell line is a basic step in the production of clinical material, …

  • Outsourcing Biopharmaceutical Manufacturing

    … facility is enormous, going up to many $100 millions in some cases, and it takes several years for a facility to be ready for operation.  Large Pharma companies are able to build their own cGMP compliant manufacturing facilities, but small or medium companies are not. With the maturity of the biopharmaceutical industry, the option of Pharma outsourcing services has become a viable and necessary production strategy.  Pharma outsourcing companies offer an attractive high-quality and economical …