Modern BioPharma Podcast

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 

Andrew Lamore on LinkedIn

ISPE CASA Annual Show 2023 

Say hi to Jesse on LinkedIn

www.modernbiopharma.com

When we think about the future of medicine, we think about companies like Iovance. Iovance Biotherapeutics, Inc. 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.  

Modern Biopharma Podcast

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

Connect with our guests:

Peggy - https://www.linkedin.com/in/peggy-banarhall-ba72412/

Tracy - https://www.linkedin.com/in/tracyradcliffe/

Jesse - https://www.linkedin.com/in/talktojesse/

Learn more about the 7000RMS at: www.mt.com

Learn more about what we do at www.modernbiopharmapodcast.com

Transcript Here 

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, 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!  

Subscribe to our channel!

Want to learn more about investment into the Cell & Gene Space?

Learn about Oligonucleotides HERE!

Quick overview about TPDs HERE!

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 I spoke with Jon Brown 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 (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://ispe.org/pharmaceutical-engineering/may-june-2020/good-engineering-practice-risk-based-commissioning

When you think of Artificial Intelligence, you may think of some scene from a movie where robots are taking over the world…well, I can’t say that won’t happen :), but I can say, that some people are starting to find ways to make manufacturing medicine more efficient using it.

On today’s episode of the Modern Biopharma Podcast, I had the pleasure of talking with Vijay Yadav, from Merck.

We didn’t talk about robots taking over the world, but we did talk about how Vijay’s team is leading the industry and finding new ways to make AI and Machine Learning useful towards a more efficient and higher quality future in the modern biopharmaceutical plant. While many are talking about it, Vijay and his team are doing it.

Listen in…today we talk about:

The Automated Vision Inspection process

What made this process a success?

What were the risks/downsides of running this technology?

What makes the culture different that you’ve been able to make such progress with AI in an industry that is so resistant to change?

How have you been able to build a team for this work? It seems that other industries are driving this kind of work

Learn more about Vijay through one of his articles:

https://ispe.org/pharmaceutical-engineering/november-december-2020/vision-inspection-using-machine

https://towardsdatascience.com/quantify-the-business-impact-of-your-data-science-project-b742e4b3208f

https://www.linkedin.com/pulse/artificial-intelligence-vs-machine-learning-whats-what-vijay-yadav-1/

In today's emerging BioPharma space, the importance of transparent and accurate records related to therapies, how they are made, where they are in a process, and the patient they are for has never been more important.

A need this large should not be relying on technology from 30 years ago. The Pharma 4.0 world has a lot of components...One way of helping the Pharma Industry catch up with the technologies they are creating is by utilizing Blockchain.  On today's episode, Najib Rehman from ATMPS and Tanya Sharma from Assurea, join me to talk about how Blockchain can be used to help our industry make a JUMP towards more available therapies for more people.    

Here are some things we discuss today:  

Some other items that we touch on are: 

Tanya Sharma - https://www.linkedin.com/in/tsharma2/ 

Naj Rehman - https://www.linkedin.com/in/najib-rehman-54011412/ 

Jesse McLaughlin - https://www.linkedin.com/in/talktojesse/ 

Modern BioPharma Podcast - https://www.linkedin.com/company/modern-biopharma-podcast

It is a RED HOT Job Market (at least right now it is in 2021)...and the Pharma market is leading the pack.  On this episode of the Modern BioPharma Podcast, I interviewed 3 different organizations to talk about what the Pharma Job Market looks like right now, how it has changed due to COVID, ways to stick out in a crowded marketplace, and more...!!!  

Our Guests today include:  

Jonathan Hart-Smith from the CK Group, a staffing and outsourcing services for the science and technology community.  

Bill Burg (https://www.linkedin.com/in/bill-burg-22651531/) and Kyle Reagan (https://www.linkedin.com/in/kyle-w-reagan-2218731/) from DECCO Inc., a mechanical contracting company that specializes in construction, maintenance, and fabrication services to leading biopharmaceutical, technology and industrial clients throughout New England.  

Shawn Fitzpatrick and Charlie Maher from Resilience, a pharmaceutical organization that is changing the way medicine is made – leveraging innovation to better serve scientific discovery, withstand disruptive events, and reach those in need.  

Listen in as we see the job market from different angles... 

Where are the biggest needs? 

What has changed since COVID changed our world? 

How to best position yourself for a position? 

How are companies changing how THEY approach the talent pool? 

How are companies developing talent as early as high school to serve in jobs that we just don't have people for?  

I hope you enjoy this episode. As always, reach out if you have any suggestions for future episodes by connecting with me on LinkedIn at https://www.linkedin.com/in/talktojesse/ or at www.modernbiopharma.com.

Diversity gives you access to a greater range of talent, not just the talent that belongs to a particular world-view or ethnicity or some other restricting definition. It helps provide insight into the needs and motivations of all of your client or customer base, rather than just a small part of it.  

One way this is being addressed in the Pharmaceutical industry is with a group called Women in Pharma (WIP) in ISPE.  

On today’s episode, I am joined by Jennifer Lauria Clark from CAI. Jenn has worked on the WIP committee both locally in the Southeast and with ISPE International for a few years. It continues to gain momentum and have a TON of energy at all the ISPE events around the world. Jenn was kind enough to spend some time with me while we were both at the 2021 ISPE Annual Meeting in Boston to discuss:  

Why she thinks Women in Pharma has such momentum? Why is diversity (in this case women) so important in the workplace?

Where are we seeing some of the biggest successes around the world in with the Women In Pharma efforts? 

How is Women in Pharma an advantage to our industry as we “compete” for new talenting coming out of universities around the world?  

We'd love feedback on this episode and others and more subjects that are important to you in the industry. Please reach out with any questions or suggestions at [email protected]

For more resources or to say hi to either Jenn or Myself:

https://www.linkedin.com/in/jenniferlauriaclark/ 

https://www.linkedin.com/in/talktojesse/ 

https://ispe.org/women-pharma 

https://cagents.com/ 

https://www.modernbiopharma.com/

What do you know about cleanrooms and why they are used in the pharmaceutical manufacturing space? How does the need for them impact your ability to get a facility operational and ready for "gametime"? If you are an early phase manufacturer, how do you make sure you protect your IP as you move forward with initial process development?  

On today's podcast, Ravi Samavedam, President and COO of Azzur Cleanrooms on Demand and I discuss the basics of cleanrooms, why they are used, where they are used, what they look like, the different ways they are implemented, and more.  The industry continues to get more efficient at setting up manufacturing facilities and new technologies help enable this. 

Unfortunately, it isn't that easy. Sometimes the time to get from the lab to small scale GMP manufacturing is prohibitive and and the line to get on the CMO roller-coaster is just too long...another solution is needed.   

Learn more about how Azzur has started helping their customers set up "Cleanrooms on Demand" so that they can get to where they need to be quickly and minimize the capital and resources needed to get there.   

Early-phase manufacturers face a myriad of challenges when it comes to starting up and scaling out: Need for clinical manufacturing capability Lack of GxP expertise Limited quality management systems Lengthy facility design-build timeframes Insufficient warehouse and materials storage Truly unique to the industry, Azzur's hybrid model allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs).    

Join us to learn about cleanrooms AND what Azzur is doing different.   

Learn more about Azzur Cleanrooms on Demand Here!  

Say Hi to Ravi on LinkedIn!  

http://www.modernbiopharma.com or our LinkedIn Page

Say hi to me, Jesse, on Linkedin