Episode 22 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly

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SUMMARY:
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Shelli Connelly is a Senior Drug Product Consultant at Design Space InPharmatics. With over 20 years of long- term success in the pharmaceutical manufacturing industry, Shelli has expertise in pharmaceutical process validation, business development activities, strategic planning, and more. In this episode, Shelli shares her thoughts on filter validation, including what to do if you pick the wrong filter, how filter vendors represent the best resources and the importance of having a partner with experience in filter validation.
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TAKEAWAYS:
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00:51 – Ed, Meranda and Brian introduce today’s guest, Shelli Connelly, who discusses her background and speaks to some of the elements of filter validation
05:41 – Shelli talks about the process of selecting a filter and why not all filters are the same
09:03 – The evolution and importance of sizing filters
11:26 – Shelli speaks to the shift to single-use disposable filters
13:05 – Qualifying a filter before validation
16:51 – Shelli explains the Bubble Point test
18:53 – Shelli expounds on everything that goes into filter validation
22:57 – How to use filters in a media simulation challenge
25:07 – Shelli’s philosophy on what to include in your filter validation
28:28 – Final recommendations Shelli would give regarding filter validation
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ABOUT CMC Live
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FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.