The biopharmaceutical industry has been very successful in the last 25 years, accounting for 11 of the 15 top selling medicines of 2017 (in the US).  We are also celebrating a surge in the approval of not only traditional biopharmaceutical medicines such as antibodies and therapeutic proteins, but also novel medicines in the area of cell and gene therapy.  Despite the success, the industry has made limited advances in lowering the cost of goods or impacting the global access of these life-changing medicines.  The new therapeutic modalities such as cell and gene therapies, though very promising from their therapeutic potential, employ technologies that have limited potential for efficient manufacturing that allows for wider access.  <br/>Meanwhile, the revolution in automation and miniaturization as well as big data, makes it possible for us to create small scale high-throughput models ranging from mL to mL volumes, that predict performance at manufacturing scale, and allows us to increase the number of experiments within process development.  As the high-throughput cell culture models undergo refinement there is significant efforts that are also on-going to integrate downstream purification and analysis into these systems. These integrated models are demonstrating that there is enormous potential for reducing the development time as well improving the quality of the processes being developed for new medicines.  <br/>As we consider most effectively harnessing the value of these recent developments for new therapeutic modalities as well as in increasing access for our medicines, an area that needs critical examination is the way process development is currently practiced across the industry, and if a new model for process development, one without the traditional silos, is timely.  This talk will focus on showcasing the possibilities of this new process development model via examples from MedImmune, where this model was applied for specific programs.  The talk will focus on how an integrated process development model enabled rapid learning, and efficient development, for novel product modalities.

Next generation bioprocess development: Let us breakdown the current barriers

2019 Spring National Meeting

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