Jon Browne - Qualification & Commissioning in Pharma

Season 4 - Andrew Lamore - ASME BPE

Today's episode is with Andrew Lamore from Burkert USA Corp and ASME BPE Chair for Multi and Single-use Process Instrumentation.   As this show airs at the same time as the 30th Annual ISPE CASA Life Science Technology Showon Feb 28 2023, we thought it would be great to discuss some of the ways these two industry groups (ISPE and ASME) compliment each other to build a safer and more effective pharmaceutical manufacturing industry.  In case you were wondering...they work "hand in glove". While you certainly could have one without the other...you wouldn't want to.   Listen in. Andrew is a wonderful guest and for anyone that has met him, you know, he's just a delight to speak with.   www.asme.org/Communities/Technical/BPE [//www.asme.org/Communities/Technical/BPE]  Andrew Lamore on LinkedIn [https://www.linkedin.com/in/andrewlamore/ ] ISPE CASA Annual Show 2023 [https://ispe.org/carolina-south-atlantic-chapter/events/life-sciences-tech-show]  Say hi to Jesse on LinkedIn [https://www.linkedin.com/in/talktojesse/ ] www.modernbiopharma.com [//www.modernbiopharma.com]

Sumit Verma of Iovance Biotherapeutics - 1 Time Therapy for Solid Tumors

When we think about the future of medicine, we think about companies like Iovance. Iovance Biotherapeutics, Inc [https://www.iovance.com/]. [https://www.linkedin.com/company/iovance/] is pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. Their lead, late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer.   At this year's ISPE [https://ispe.org/conferences/2022-annual-meeting-expo] Annual Meeting in Orlando FL, I had the chance to sit down and talk about some of the things that Iovance is doing with Sumit Verma [https://www.linkedin.com/in/ACoAAAF7WxkBLG2J_7ujqnsAmXh91uromrMX8_w], Senior Vice President Global Strategic Manufacturing.  It was obvious to me that not only is Sumit very engaged on the "facility" level of what needs to happen to make a successful facility for our modern therapeutics, but he is passionate about the patients that Iovance is helping. This isn't just a job, its a mission.   The future of cell and gene therapy is a fascinating one, and what Sumit and his team at Iovance Biotherapeutics are doing will have monumental, life saving effects in the lives of so many where before there was little hope. Listen in our conversation! Modern Biopharma Podcast [http://www.modernbiopharmapodcast.com] Say hi on LinkedIn [https://www.linkedin.com/in/talktojesse/]

Rapid Microbiological Testing with Peggy Banarhall and Tracy Radcliffe of Mettler Toledo

Peggy Banarhall and Tracy Radcliffe on Rapid Microbiological Testing in Pharma Waters It is hard to overemphasize the importance of water in the pharmaceutical manufacturing process. And when it comes to microbiological contamination, one of the biggest hurdles to understanding what is going on in your system is the time it takes to test. On this episode of the Modern Biopharma Podcast, I get to speak with Peggy Banarhall and Tracy Radcliffe from the Mettler Toledo team in their studio about their new technology for the rapid testing of bioburden in pharmaceutical water systems. This is a paradigm shift in understanding and dealing with bioburden. You don't need to only do a 100 year old test to figure out the health of your water system anymore. You can know what is going on RIGHT NOW...not find out in 3 days. Join us as we discuss the ins and outs of this technology and how it could help you with your system. At around the 46 minute mark we start a Demo on the unit, which may not make sense just listening to it. You can always switch over to the Youtube video at: https://youtu.be/2N5YFQYJQzQ [https://youtu.be/2N5YFQYJQzQ] Connect with our guests: Peggy - https://www.linkedin.com/in/peggy-banarhall-ba72412/ [https://www.linkedin.com/in/peggy-banarhall-ba72412/] Tracy - https://www.linkedin.com/in/tracyradcliffe/ [https://www.linkedin.com/in/tracyradcliffe/] Jesse - https://www.linkedin.com/in/talktojesse/ [https://www.linkedin.com/in/talktojesse/] Learn more about the 7000RMS at: www.mt.com [http://www.mt.com/] Learn more about what we do at www.modernbiopharmapodcast.com [http://www.modernbiopharmapodcast.com/] Transcript Here [https://docs.google.com/document/d/e/2PACX-1vSZ1twFgxn1wQFDJpoS-vcHkoNKTGCcxTxXD3fke0pw50xIVBS3ui_K6JeWSAJV62RSB7rm7X6eLDU1/pub]

Jake Adams - CRB - The Future of ATMPs

ATMPs...or Advanced Therapeutic Medicinal Products, are the "next big thing" in the world of #Pharma. If you are in the space, the big ones you hear most about are Cell & Gene Therapy and...lately...mRNA vaccines (thank you COVID-19).   This world isn't as simple as 2 or 3 therapies...it's more than that. Investment in Cell&Gene Therapy has been setting records with $20 and $23 Billion in the last 2 years alone. This is kind of a big deal.  Jake Adams, from CRB [https://www.crbgroup.com/], joins me to discuss this and also the world of #RNA modulating therapies (not all as well known as mRNA Vaccines).    We discuss what makes these different therapies unique, what makes them effective, and more. Also a few rabbit trails including how did Jake turn into a go-to man for RNA as a young engineer. So listen up... :)   Check at Jake on LinkedIn [https://www.linkedin.com/in/jake-adams-27620349/]!   Subscribe to our channel [https://www.youtube.com/c/ModernBiopharmaPodcast]! Want to learn more about investment into the Cell & Gene Space? CGT 2022 Investment Outlook [https://www.cellandgene.com/doc/cell-gene-therapies-investment-outlook-in-beyond-0001#:~:text=Early%20Approvals%20Pave%20The%20Way%20For%20New%20Market%20Entrants&text=The%20number%20of%20approved%20treatments,are%20cord%20blood%2Dbased%20treatments] Learn about Oligonucleotides HERE [https://www.certara.com/blog/maximizing-oligonucleotide-therapeutic-development-how-they-work/]! Quick overview about TPDs HERE! [https://www.eurekaselect.com/article/105757]

Jon Browne - Qualification & Commissioning in Pharma

If you are anywhere around the commissioning and qualification space, you know how important it is to any #Pharmaceutical facility. There are so many resources out there to understanding how to approach these processes and on today’s episode of the Modern Biopharma Podcast [https://www.modernbiopharma.com/] I spoke with Jon Brown [https://www.linkedin.com/in/jonbrowne/] about his experience coming into a new facility and how he approached the substantial task of managing the commissioning of one of the largest Water For Injection (#WFI) systems in the world. Jon is a graduate of the University of Utah and currently works as a consultant in the RTP area serving pharmaceutical manufacturers there. I really enjoyed getting to know Jon through our conversations Questions we cover in the podcast: Tell me a little about yourself and what you currently do. 2:05 - What is a book that you’ve recently read that you especially enjoyed? Algorithms to Live By [https://www.amazon.com/Algorithms-to-Live-By-audiobook/dp/B01D24NAL6/ref=sr_1_1?crid=2H1Z0OWSPCN0D&keywords=algorithms+to+live+by&qid=1646109564&sprefix=algor%2Caps%2C116&sr=8-1] (already started it and really enjoying it) 6:00 - Today we’re going to talk about commissioning and qualification of water systems…tell me more about why you enjoy working on water systems 8:00 What was your “task” and how did you approach CQ differently for this project? 15:00 - What do you care about in your quality system? 26:00 - How do we determine system boundaries? 36:30 - How important is it to both define those boundaries and DEFEND those boundaries from a quality perspective? 49:40 - What’s the number #1 thing you’d encourage a CQV team to do as they embark on a new system? As some follow-up reading, here is a great article about Good Engineering Practices in Risk-Based Commissioning and Qualification by Chip Bennett [https://www.linkedin.com/in/chipbennett/]. https://ispe.org/pharmaceutical-engineering/may-june-2020/good-engineering-practice-risk-based-commissioning [https://ispe.org/pharmaceutical-engineering/may-june-2020/good-engineering-practice-risk-based-commissioning]