Tag Archives: book

  • Bottlenecking Theory

    Bottlenecking Theory Lean Biomanufacturing, by Dr. Nigel J. Smart Understanding this theory can help address key concepts that can help your research team yield optimal results. It’s important to begin your research by first running through some equations that will help your team throughout your experimental endeavors. After all, you wouldn’t read a book if you didn’t know its terminology first, right? It’s important to be well versed in the material that you are working on in order to …

  • Innovative R&D Through Lean Manufacturing Principles

    The term “lean manufacturing” was first coined by James Womack, a professor at MIT, in his 1990 book titled The Machine that Changed the World. Lean manufacturing techniques have gained a growing number of advocates within the pharmaceutical industry since then, but there has also been controversy, as well as a residual reluctance to implement these principles in certain areas. For example, people can readily see the value of a lean manufacturing process for manufacturing, supply …

  • How to Prepare for the New Structure for Approval of Follow-on Biologics

    … and any patent litigation conditions that may come along. 1.    Understand your patent portfolio HR 1427 and HR 1548 do not mention the creation of an Orange book equivalent for follow-on biologics, but require that the BLA holder identify relevant patents when the follow-on biologic candidates request it.  Review your patent portfolio right away to understand which characteristics of your products and processes are protected, what the scope of this protection is, when the patent term ends, …