Modern BioPharma Podcast
By Jesse McLaughlin
Modern BioPharma PodcastApr 14, 2020
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.
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. 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 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, 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!
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
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
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, 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!
Want to learn more about investment into the Cell & Gene Space?
CGT 2022 Investment Outlook
Learn about Oligonucleotides HERE!
Quick overview about TPDs HERE!
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 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.
AI-ML in Pharma Manufacturing - Vijay Yadav - Merck
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:
AI vs ML – Explain the difference
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://www.linkedin.com/pulse/artificial-intelligence-vs-machine-learning-whats-what-vijay-yadav-1/
Blockchain in Pharma - Tanya Sharma and Najib Rehman
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:
- Explain Blockchain to me like I'm a 10 year old.
- Who owns blockchain? It has a reputation for being very secure...why is that?
- Why are you advocating for using blockchain in the Pharma Industry? Are there particular areas within the industry that blockchain is best suited for?
- Is there a certain level of adoption needed to make this "work" or is the infrastructure already in place?
- How does blockchain impact 21 CFR Compliance?
- What downsides are there to instituting blockchain?
- How does using blockchain as a tool in Pharma help to serve the patient?
Some other items that we touch on are:
- Need for competitor cooperation
- Paper versus digital
- Digital disintermediation of supply chains
- Personalized medicine - patient centric
- How do you "manage forever"?
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
The Pharma Job Market - An Interview Mashup
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.
Women in Pharma - An Interview with Jennifer Lauria Clark
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 modernbiopharm@gmail.com
For more resources or to say hi to either Jenn or Myself:
https://www.linkedin.com/in/jenniferlauriaclark/
MBP - Ravi Samavedam - Cleanrooms on Demand
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
Integrated Project Delivery - Josh Miksch - CRB ONEsolution
When a new facility needs to be designed, built, and started up...there is a lot to consider. And a number of ways to approach it.
Today I speak with Josh Miksch from CRB about their ONEsolution approach to delivering a facility in the Pharmaceutical space.
From the CRB website: "ONEsolution™ is a revolutionary integrated project delivery method that leverages the combined expertise and technical excellence of ONE project team to deliver your facility in a safe, lean and collaborative way. ONEsolution™ aligns stakeholders on quality, cost and schedule, providing you with everything you need from initial planning through operational readiness. You know the old saying. “Cost, quality, or schedule. You can only pick two.” We’re throwing that out the window and disrupting the current state of the construction industry."
It was pretty exciting to be able to do our FIRST "Live" podcast. Given my newness to this space...I have a challenge for you...see if you can spot the 2 points I had to edit the video. We had a couple of technical difficulties, but we made it through. Josh was a great guest. Great to get to see him and his new office post COVID lockdown.
Have any questions about the ONEsolution approach? Ask them here on our LInkedIn post here. I'll see if I can get Josh to say hi and answer them :)
https://www.linkedin.com/in/talktojesse/
Predicting Diaphragm Valve Failure - Milena McFeeters
Ever wanted to have a Crystal Ball?
Did you know that the #1 suspect for a process line failure is diaphragm valves and gaskets?
On this episode of the Modern BioPharma Podcast (www.modernbiopharma.com) I am joined by Milena McFeeters from the BioProcess Institute to talk about the failure modes of Diaphragm Valves. Interesting right…?
Well, if most of the Pharma Process failures are due to things you could do a better job predicting, this just might be the episode for you :) The Consumer Reports of the Pharma Industry, the BioProcess Institute has put together a comprehensive failure mode test and results that show the reliability of different manufacturers and the kinds of failures that are typical under different stresses and environments (CIP and SIP).
In this episode we discuss a number of things that are shown visually. You can both get a "cheat sheet" and the full report at https://bioprocessinstitute.com/. you can also watch this episode on our Youtube Channel.
Make sure you say hi on LinkedIn:
https://www.linkedin.com/company/modern-biopharma-podcast
https://www.linkedin.com/in/talktojesse/
Or Subscribe on your favorite Podcast Player.
Maintenance 4.0 - Tobias Kuners of Koenders - Season 2
Industry 4.0 is a name given to the current trend of automation and data exchange in industrial technologies. It includes the Industrial Internet of Things (IoT), wireless sensors, cloud computing, artificial intelligence (AI) and machine learning. Today on the podcast we discuss Maintenance 4.0 and how it is being implemented and can be implemented across the Pharmaceutical Industry.
Our guest today is Tobias Kuners of Koenders (https://www.linkedin.com/in/tobiaskunersofkoenders/). Tobias has more than 30 years of experience across multiple facets of operations including Project Management, Facilities Services, Maintenance, Engineering, Validation, Packaging and Supply Chain within highly regulated industries. He is the managing consultant at Tob Management, a Netherlands-based consulting firm providing business and technical expertise to the pharmaceutical, biotech, medical device, and FSMP (food for special medical purpose) industries.
Here's what we discuss on this episode:
First off, before we get started, just to get to know you a little better...what is the last book you read? Dutch Light: Christiaan Huygens and the Making of Science in Europe https://www.amazon.com/Dutch-Light-Christiaan-Huygens-Science-ebook/dp/B085NWR3QL/ref=sr_1_1?dchild=1&keywords=dutch+light&qid=1621872488&sr=8-1
What is Pharma 4.0 as defined by the ISPE SIG? What is “Maintenance 4.0” and how does it fit into the Pharma 4.0 framework? (Here is one of Tobias' articles: https://www.biosimilardevelopment.com/author/tobias-kuners-of-koenders)
We had some lag on this interview so you may notice some "cuts" as I tried to take out as much of the awkward as possible :).
The 5 Core Aspects of Maintenance 4.0...Periodic Inspection, Prescriptive Maintenance, Preventative (Routine) Maintenance, Predictive (Reliability) Maintenance, and Corrective/Reactive Maintenance. Where do you see the largest upside from where we are at today to in the future in these 5 core aspects?
As the data set available to us continues to grow, it seems overwhelming. How do companies prioritize data for good use rather than get buried by it and resort to either “over PMing” everything or corrective/reactive maintenance? How have you seen this done with one of your clients?
Let’s talk about existing facilities vs new facilities. It would seem an existing facility transition to Maintenance 4.0 could be very difficult from a “culture” perspective while at a new facility, there is a lack of history to work from developing KPIs and benchmarking. Can you talk to some of the issues an older facility vs a new facility might run into?
If you were to speak with a new client, what would be the first thing you would tell them to begin to look at to start the transition towards Maintenance 4.0?
Emergency Use Authorizations - MMS Holdings Interview - MBP Season 2
The COVID-19 Vaccine has brought to the forefront an awareness of something called an Emergency Use Authorization (EUA). As a result, the questions swirl around what they are and what they mean to the safety of the vaccine and other therapies surrounding COVID-19. Listen in as we discuss this very important topic.
Our guests today are:
Dr Uma Sharma - Chief Scientific Officer - MMS Dr Sharma provides oversight for all clinical activities especially submissions and complex regulatory projects. As needed by their sponsors, she leads advisory committee meetings and participates in advisory boards for drug development, as well as product defense strategies especially for critical safety issues and label strategy discussions. With more than 24 years of experience in the pharmaceutical industry, she has been an invited speaker at several national and international events.
Ben Kaspar, Senior Manager Regulatory Strategy Ben works with sponsors to plan their programs and navigate the regulatory submission process throughout the entire drug development life-cycle. Ben and team have a deep experience in regulatory science for drug/biologic development, designing innovative strategies to maximize the likelihood of regulatory approval of the target across a variety of therapeutic areas including rare diseases.
Here are some of the topics we cover today:
What is the last book you read?
What is an EUA and why are we hearing so much about them now?
Does a EUA allow a drug to be used around the world during a pandemic? Is this just a thing for the US or some subset of countries?
Are All COVID related approvals an automatic EUA?
If we are able to get an EUA for something like COVID, why can’t every unmet condition have an EUA? Certainly plenty of other conditions are even MORE serious to many people.
Are EUAs easier than regular approvals? Public perception is that these are a short cut and all studies are not completed. I think the thing I hear about the most is the “long term studies”...
Are EUAs here to stay after the pandemic? Will there be more EUAs than before? Have we broken through some imaginary barrier that will now allow us to do this more often?
What do you think the industry can learn from this effort for future growth and streamlining discovery/testing efforts?
Reach out to MMS Holdings... https://www.mmsholdings.com/
Dr. Sharma on LinkedIn - https://www.linkedin.com/in/umasharmaphd/
Ben Kaspar on LinkedIn - https://www.linkedin.com/in/benkaspar/
Reach out to me on LinkedIn https://www.linkedin.com/in/talktojesse/ or on my website at https://www.modernbiopharma.com/.
MBP - Ross Youngs - Biosortia - The Future of Drug Discovery
What if we could use the OTHER 99% for drug discovery...not just the 1%?
In the world of drug discovery, for the most part it hasn't change much in decades. Ross Youngs, CEO of Biosortia Pharmaceuticals is looking to change that with a better understanding of the microbiome.
The Biosortia technology opens the doors to previous unobtainable drug-like signaling molecules and will impact all therapeutics, agriculture, cosmetics, and other industries. Importantly - researchers have had less than 1% of this source previously available & that small percentage has still led to more than 50% of the drugs on the shelf - the door is now open to potentially the full 100% of the source (this is World-Changing).
Pharma's past failures to deliver costing billions of dollars a year in combinatorial chemistry & genomics with few drug on the shelf has resulted in tunnel vision & lack of research adventurism. Listen in on our conversation. Hear the passion Ross has for this technology and the future of drug discovery.
Learn more about Biosortia Pharmaceuticals at https://www.biosortia.com/.
Reach out to Ross on LinkedIn at https://www.linkedin.com/in/rossyoungs/.
Thanks for listening to the Modern Biopharma Podcast.
Check us out at http://www.modernbiopharma.com or hit me up on LinkedIn at https://www.linkedin.com/in/talktojesse/.
MBP - Gil Roth - Pharma and Biopharma Outsourcing Association
On episode of 18 of the Modern Biopharma Podcast, I got to sit down with Gil Roth, President of the PBOA (Pharma and Biopharma Outsourcing Association), the nonprofit trade association representing CMOs and CDMOs. You can find more info about PBOA at http://pharma-bio.org and contact Gil at gil.roth@pharma-bio.org.
As president of the Pharma & Biopharma Outsourcing Association,Gil is responsible for developing and advancing the agenda of our member companies in the regulatory, legislative and general business areas. This involves organizing and communicating with members and other industry participants, interacting and negotiating with FDA and other regulatory agencies, lobbying Congress and working with federal agencies, building committees and working groups in a variety of areas, and developing cross-platform programs with other trade associations. He has organized workshops and conferences for our members, written and delivered presentations at FDA hearings and industry events, testified to Congressional subcommittees, conducted industry surveys, coordinated panels for our trade-show partners, developed the association's website, compiled the e-mail list for the weekly e-newsletter (which he also produces), marketed and recruited dozens of new member companies, composed press releases, and designed marketing materials.
Among PBOA's signal achievements are successfully renegotiating a multibillion-dollar user fee agreement with terms more favorable to the CMO/CDMO sector, launching the industry's first CMO/CDMO-only conference, and becoming the point of contact for regulators seeking to learn more about this industry.
We talk about what the PBOA is doing and where it is headed, how COVID-19 is impacting the industry as a whole, what kind of impacts there have been to the supply chain, and more.
Gil is a fascinating guy working hard for the industry.
You can learn more about his organization at: https://www.linkedin.com/in/gil-roth-93a6711/ or https://pharma-bio.org/
Check out more of the Modern BioPharma Podcasts at http://www.modernbiopharma.com
Connect with me, Jesse, on LinkedIn at https://www.linkedin.com/in/talktojesse/ or on Twitter at https://twitter.com/talktojesse
MBP - Jesse Coiro - Erlab
Heard of a thing called COVID? No?
Well, today's guest is extremely knowledgeable in the way microscopic particles in the air can affect your health AND ways to help remove them from your surrounding to improve your health. Jesse Coiro is the Director of Business Development for Erlab, who's tagline is "You Can Breathe".
On this episode we cover a number of issues, including:
The primary means of COVID transmission and why it is important to the BioPharm community.
While it really is amazing how much of the workforce has been able to "go remote", it certainly isn't possible for everyone, especially in the pharma space where we have to continue to manufacture, package, deliver and on the front end lots of time in the lab. Where are the biggest risk areas in these environments?
Other than social distancing and masks...what are other means of minimizing risk/exposure in the workplace? Specifically the kind of solutions Erlab is providing.
I hear people say frequently "What's the point if we can't get rid of all of it, why bother?"
The difference between "dillution" and room level mitigation.
Some of these solutions might be too big of an investment given the prospect of COVID "going away" in the not too distant future. Is it worth the money or should we just maintain our distancing with masks a little longer?
As we continue finding our way through COVID, what is the one thing you'd most like to share with the Biopharm community?
#10years...if you could go back and tell yourself one thing 10 years ago, what would it be?
I hope you enjoy this episode with Jesse. I definitely learned a few things.
Look up Jesse on LinkedIn at https://www.linkedin.com/in/jesse-coiro/ or Erlab at https://www.erlab.com/usa/.
Want to see the product (Halo) we are talking about?
https://www.erlab.com/710-1076-halo-laboratory-grade-air-filtration-system.html
Want to get a hold of me? Hit me up on LinkedIn at https://www.linkedin.com/in/talktojesse/ or email me at modernbiopharm@gmail.com.
Since putting up the episode, we've gotten a number of requests for more info. Just visit the Erlab website and fill in your information and they will get right back to you --- https://usa.erlab.com/contact-us
MBP - Jarrod Wrampe - CRB
Early on in COVID I was able to sit down and speak with Jarrod Wrampe from CRB. We had some recording issues, so it took some processing to finally get this episode released. He's a busy guy, so I wanted to make the most of our time we had rather than wait for another opportunity to record a new episode.
As the Biotech Team Leader in the Kansas City office with almost 20 years experience, Jarrod is a wealth of experience in the Biopharm space.
In this episode we get to know Jarrod a little bit and then discuss a number of different topics:
Why would a facility choose single use vs stainless? What factors weigh heavily in this decision?
Why would ozone be chosen instead of heat for sanitization in water systems?
What are the risk factors with ozone?
What kind of companies are more open to this as an option vs traditional heat sanitization?
Jarrod was a great guest and I really enjoyed spending time getting to know him and understand some of his background.
Please reach out if you have any suggestions on guest for the podcast! We'd love to hear from you.
And reach out to me on LinkedIn or Twitter
Visit Modern Biopharma at http://www.modernbiopharma.com
MBP - Kevin Chronley - A/Z Corp
Today on the Modern Biopharma Podcast we sit down to talk with Kevin Chronley, Vice President at A/Z Corp.
Kevin and I have known each other for a number of years now as he is very active in the Boston chapter of ISPE and A/Z Corp is very active in the life sciences industry in New England.
This discussion is getting to know Kevin, who he is, and some of his experiences in the industry.
Here are some of the questions we discussed:
Tell me a little about yourself How did you get involved in the BioPharma industry?
How have you seen the industry change since you’ve been working in it?
Tell me about the kinds of projects you’ve worked on or maybe a specialty you have?
What’s an improvement you’d like to see in how we manufacture medicines today?
Tell me about something you are excited about in our industry?
Relating to your work in BioPharma, what is something you’d tell your 10 year younger self that you wish you’d known.
Do you have any parting thoughts you’d like to share?
Check out our other Episodes at https://www.modernbiopharma.com/
MBP - Brian Hagopian - Clear Water Consulting - Part 3 Rapid Microbiological Monitoring
In Part 3 of our water series with Brian Hagopian we discuss Rapid Microbiological Monitoring of pure water systems.
This is a technology that continues to get attention as it matures in the Pharma space. With microbiological control being so important to the modern water system in a BioPharm plant, understanding what is going on on the micro level is too important to have to always wait for a multi-day test result.
Here are some of the items we discuss:
What is the reason behind microbiological monitoring in a water system? What are you looking for?
How do we currently monitor these things? What are the shortcomings of this way of measuring for micro?
Explain what RMM is.
Why is RMM all the sudden making a splash? Is it new, or has it been around a long time?
Why does RMM make sense?
What is holding it up as an accepted technology?
What about endotoxins? How do we handle those?
What does the future look like for this new technology? Do you see it being used in another industry where it can “earn” its reputation?
Brian is an industry expert with over 30 years high purity water system design, construction, commissioning, and validation experience delivering a wide range of solutions to premiere pharmaceutical, biotech, semiconductor, research and other high technology clients. A recognized industry leader and active volunteer with numerous professional societies, past president of the Boston Chapter of the International Society for Pharmaceutical Engineering (ISPE) and contributing author and lecturer on topics associated with USP purified water (PW), water for injection (WFI) and semiconductor grade water. As a past executive for several water system companies, Brian brings extensive knowledge related to high purity systems engineering, operations, and piping system design.
Check out 2 Premier Suppliers of this technology:
#reverseosmosis #wfi #pharmawater
MBP - Brian Hagopian - Clear Water Consulting - Part 2 Sampling & Monitoring
In part 2 of our water series with Brian Hagopian we discuss sampling and monitoring of pure water systems. Understanding what is and isn't in your pure water system is critical to ensuring the safety and efficacy of your product. Brian has been a part of defining many of these rules over the decades. He was a member of the team that wrote the ISPE Good Practice Guide: Sampling Pharma Water, Steam, and Gas Processes.
Here are some of the things we covered in this episode:
What has sampling and monitoring looked like in pure water treatment over the years?
What are the major types of constituents we sample and monitor for in a Pure Water system?
How are these prioritized in a Pharma system?
Why do we have to sample all over a pharma system? Why can’t we just measure like we do conductivity at supply and/or returns of a loop?
How do you decided to use an analyzer vs sampling of various constituents?
Want to watch this episode? Check it out at: https://youtu.be/Zq230CJqCU4
Brian is an industry expert with over 30 years high purity water system design, construction, commissioning, and validation experience delivering a wide range of solutions to premiere pharmaceutical, biotech, semiconductor, research and other high technology clients. A recognized industry leader and active volunteer with numerous professional societies, past president of the Boston Chapter of the International Society for Pharmaceutical Engineering (ISPE) and contributing author and lecturer on topics associated with USP purified water (PW), water for injection (WFI) and semiconductor grade water. As a past executive for several water system companies, Brian brings extensive knowledge related to high purity systems engineering, operations, and piping system design.
MBP - Brian Hagopian - Clear Water Consulting - Part 1 Micro-Electronics Water vs Pharma
Did you know that standards for Microelectronics water are FAR more stringent than those for the Pharmaceutical industry? By any measure, the water used in manufacturing semi-conductors is superior to what is used in pharmaceutical manufacturing.
On Part 1 of my discussions with Brian Hagopian from Clear Water Consulting talking water, we discussed some of what makes them different and what we can learn from what they do. Here are some questions we discuss:
Every industry has different “drivers” for how and why certain water quality is needed. What do you see as the main drivers for water quality in the Pharma market?
How has the Pharma market progressed over the years in relation to improving water quality? What have been the barriers?
Can you share how the micro-electronics market is leading the way in water quality technologies?
What are the drivers in this market and how are they able to make changes more easily/differently than the Pharma market?
Does the micro-electronics market have the same documentation requirements as the Pharma market?
How can the Pharma market change moving forward learning from the micro-electronics systems installed around the world? What do you see as the main risks associated with these kinds of changes?
Want to WATCH this episode? Check it out at: https://youtu.be/hFUGMRA54xo
Brian Hagopian is an industry expert with over 30 years high purity water system design, construction, commissioning, and validation experience delivering a wide range of solutions to premiere pharmaceutical, biotech, semiconductor, research and other high technology clients. A recognized industry leader and active volunteer with numerous professional societies, past president of the Boston Chapter of the International Society for Pharmaceutical Engineering (ISPE) and contributing author and lecturer on topics associated with USP purified water (PW), water for injection (WFI) and semiconductor grade water. As a past executive for several water system companies, Brian brings extensive knowledge related to high purity systems engineering, operations, and piping system design.
MBP - Jeff Wassenaar - Astro Pak - All about Electro Polishing
On Episode 11 of the Modern BioPharma Podcast we speak with Jeff Wassenaar of Astro Pak for Part 2 of our discussion. This time we talk about Electro Polishing.
Here are some questions we cover in this episode:
Talk to me about Surface Finish. Why is it so important in the Pharma space?
When I visit a Pharma facility, there is a lot of "shiny" stainless steel, where is surface finish important?
We hear a lot about EP or electropolish? What makes it different from mechanical polishing? Is it really better?
I’ve heard a lot of people say if something is EP’d it doesn’t need to be “passivated”...is this true? There seems to be many that say an EP finish is the “most” passive. It seems like surface finish would be difficult to maintain.
How do companies determine when it is worth it to remediate damage to surfaces and how is this done?
Want to WATCH this episode? Check it out at: https://youtu.be/nHBh6Dxtw7I
Do you have any questions about electro polishing? Let me know what they are and we'll work on getting you some answers.
You can find Jeff at https://www.linkedin.com/in/jeffwassenaar/.
You can learn more about AstroPak at https://astropak.com/
MBP - Jeff Wassenaar - Astro Pak - All About Passivation
On Episode 10 of the Modern Biopharma Podcast, we talk with Jeff Wassenaar from AstroPak about Passivation.
Some of the questions we discuss:
How do you feel the overall knowledge of Cleaning/Passivation is in the pharmaceutical industry?
Can you give me a quick background on what Passivation is and why it is important?
How is passivation different from “derouging”? or “pickling”?
What are some of the processes you get involved in from a cleaning/passivation/derouging perspective?
Why are these processes not just automated if we know they will be necessary?
With the increasing amount of single use facilities, how is that changing the need for passivation services onsite?
Want to WATCH this episode? Check it out at: https://youtu.be/FNEDa-4411g
You can find Jeff at https://www.linkedin.com/in/jeffwassenaar/.
You can learn more about AstroPak at https://astropak.com/
The Youtube video at https://youtu.be/FNEDa-4411g includes some graphics discussed during the episode.
MBP - Merrilee Whitney - MilliporeSigma
On Episode 9 of the Modern BioPharma Podcast we have Merrilee Whitney from MilliporeSigma on to discuss the launch of the BioContinuum Platform.
The current paradigm shift and digital transformation in biomanufacturing will result in a facility of the future that is truly an ecosystem of intensified, connected & continuous processing seamlessly coupled with uninterrupted data acquisition and analysis. Together, this will make real-time lot release and lights-out manufacturing achievable to the ultimate benefit of patients around the globe, expanding access to affordable life-saving and life-enhancing biotherapeutics. Merrilee Whitney is the Head of the BioContinuum Platform at MilliporeSigma.
This episode is also available on YouTube at: https://youtu.be/ehVnDIDCLio
You can find Merrilee on LinkedIn at: https://www.linkedin.com/in/merrilee-whitney-02aa939/
Want to learn more? Check out their site at https://www.emdmillipore.com/US/en/20180329_155610
MBP - James Zwiefel - Burns and McDonnell
COVID-19 has had an immediate and drastic effect on the Global Economy. Particular attention has been placed on some critical industries to include the BioPharma industry and its ability to continue full scale production with the limitations placed on the Global Supply Chain.
On today's episode, James Zwiefel from Burns & McDonnell discusses the state of our existing global supply chain and how we move forward with the "new normal" with how companies and policy makers look to balance priorities to include the risk of a scenario like a worldwide lockdown in mind.
What does this look like? What about maintaining a more significant reserve? How much of API production should be domestic vs international?
This conversation is just beginning. What do you think? How has this impacted your business life?
Want to WATCH this episode? Check it out at: https://youtu.be/XKYvQUSFWmA
Connect with James at: https://www.linkedin.com/in/jameszwiefel/
Or visit Burns and McDonnell at https://www.burnsmcd.com/
MBP - Brian Duffy - IPS
Brian Duffy is the Director of Process Engineering at IPS in Chelmsford MA. His career has seen him in various positions at some of the big BioPharma companies in the Boston area.
We cover his time in the industry, the changes in the industry modular cleanrooms have introduced, and some of the amazing changes happening in the cell and gene therapy arena.
Say hi to Brian on LinkedIn at: https://www.linkedin.com/in/brian-duffy-9a23387/
If you have someone you think we should interview, please reach out to me directly on my LinkedIn page at: https://www.linkedin.com/in/jesse-mclaughlin-4bb1668/
MBP - Erich Bozenhardt - IPS
The Do's and Don'ts of commissioning a #RABS. That's one of the many things that Erich and Herman Bozenhardt have written about in their informative articles published at bioprocessonline.com. They share their experiences of helping customers through engineering and process challenges regularly in articles and their own podcast, Bioprocess with the Bozenhardts, hosted by #bioprocessonline.
This was a great opportunity to meet Erich and learn more about why he does what he does and hear some stories about the right and wrong way to deal with RABS, especially in a retrofit scenario. The #modernbiopharma Podcast Episode #6 is up today.
The original article can be found here:
Connect with Erich here: https://www.linkedin.com/in/erich-bozenhardt-pe-a405b518/
Connect with Jesse here: https://www.linkedin.com/in/jesse-mclaughlin-4bb1668/
If you have a guest you think we should interview, or if you'd like to be interviewed, please reach out to me on LinkedIn or Twitter
MBP - Rick Pierro - Superior Controls
Rick Pierro is an institution in the New England area Biopharma space. He has been leading his company, Superior Controls, for many years and been active in organizations like the ISPE Boston Area Chapter for as long.
It was a pleasure speaking with Rick for this episode of the podcast and hear more about what he sees in the industry in his role at Superior.
He speaks about the role of #BigData in Biopharma, the impact #celltherapyand #genetherapy are having on the world of medicine, and ways he thinks many facilities could improve on their status quo.
Sorry the video is just a picture today...we had some technical difficulties due to my home "studio's" internet connection...there will be a couple more as I get the bugs worked out of this new endeavor....but the message came through nice and clear.
#modernbiopharma
MBP - Michael Rodionov - MMR Consulting
Michael Rodionov is a Principal Engineer for MMR Consulting based out off the Toronto area with specialties in Clean Utilities, Sterile Fill & Finish, Washing & Sterilization, cGMP Facilities Design and both Upstream & Downstream processes.
We had a great discussion about the Biopharma industry with a particular focus on how he and his team approach critical utilities in a plant. We also had a good conversation about project delivery models and why he thinks the small to midsize engineering firms can help their clients build a "dream team" for better project execution in the end.
Listen in our conversation!
MBP - Joe Reale - Repligen Corporation
He is leading the COVID response team at all of their facilities around the world to respond to the changing landscape. Between ensuring the safety of his employees and maintaining production for the critical supply flow to his customer base we get a unique insight into his approach.
I love his advice on "failing fast" too. Joe leads by example and is a standout in our industry. I hope you enjoy as much as I did.
MBP - Kevin Mitchell
Modern BioPharma Podcast - Kevin Mitchell of TEK Stainless Piping Products Kevin is a good friend of mine that has been working in the BioPharma industry for over 20 years. We've worked together in ISPE and share a lot in common personally (not our haircut :)).
MBP - Eric Felz
Last week I got to sit down with Eric Felz to talk about his experience in the BioPharma industry, how COVID-19 has impacted his work life, and the things he is excited about as our industry marches forward.
Eric currently is a Director at Takeda here in the Boston area, the sitting President of the ISPE Boston Area Chapter, and an all around good guy. Give it a watch/listen!