Beyond the lungs cystic fibrosis also effects the digestive system and sweat glands. Typical symptoms of cystic fibrosis include a chronic cough, wheezing, difficulty breathing and germ growth in the lungs that people with healthy lung function tend not to have, increasing the opportunity for infection. Living with cystic fibrosis is difficult and often dictates a very restrictive lifestyle. More than half of the cystic fibrosis population is age 18 or older.More than 75 percent of people with cystic fibrosis are diagnosed by age 2.Approximately 1,000 new cases of cystic fibrosis are diagnosed each year.More than 30,000 people in the US are living with cystic fibrosis (more than 70,000 worldwide).According to the Cystic Fibrosis Foundation Patient Registry, in the United States: It affects the cells that produce mucus, causing the mucus to be excessively thick and sticky, reducing lung function. Cystic fibrosis is a rare genetic, life threating disorder that damages the lungs and digestive system. Both of their approved products are for the indication of cystic fibrosis (CF). A 2nd product (Symdeko) was approved in early 2018. Vertex was the first firm to secure a Continuous Manufacturing FDA product approval in July of 2015, with Orkambi. In this blog, I would like to focus on this patient aspect of Continuous Manufacturing, highlighting three firms who have recently won FDA approval and whose Continuous Manufacturing produced products are making a life difference to many. What has not been as widely publicized are the significant patient benefits Continuous Manufacturing has brought, via the life-changing/life-enhancing quality drug products being produced and supplied to market via the Continuous Manufacturing platform. Continuous Manufacturing for OSD is a transformational platform that is here and is here to stay. The Continuous Manufacturing ball is rolling and our industry is well positioned for even further advancement in this arena and many more new drug approvals are anticipated in the years ahead. We’ve confirmed business case advantages, worked with QbD to achieve process robustness and have proved the platform capabilities to the FDA and other regulatory agencies, who have awarded the industry with several recent drug approvals. We’ve heard about the various direct compression, dry granulation and wet granulation Continuous Manufacturing platforms, the range of equipment design and configurations offered and the many facility size and cost reduction opportunities owners have seen. In recent years much has been written about and presented on regarding the significant technical processing benefits of Continuous Manufacturing (CM) in the production of Oral Solid Dose Forms, namely coated Tablets. Life Changing and Life Enhancing Drug Products via Continuous Manufacturing Introduction:

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