The Benefits Of Converting To Single-Use For Bioprocessing Systems

Source: CPC
single-use interview of john boehm with colder products

At Interphex 2014, Todd and Todd interview John Boehm, business unit manager in bioprocessing with Colder Products Company to dicuss the advantages of converting your bioprocessing systems to single-use. The big picture topics would be lower operating costs, reduced contamination risk, improved production yield, increased process flexibility, but some specifics on that is if you look at the economic advantage, it starts right away with when you're developing a new drug, in today's market, there's a lot of smaller population drugs, not the big blockbusters.


Interview transcription:

Todd S: Good morning. This is Todd and Todd, live in New York, Life Science Connect Radio on location, direct from Interfex day two. An exciting guest up next, Todd Youngblood, but gosh, I'm just having a great time so far. We're off to a great start.

Todd Y: I am, and the technology at a show like this really blows me away, particularly when I think in terms of the impact that it has, when you're talking about pharmaceutical and the difference it makes in people's lives. It adds a whole other dimension to the technologies these folks are bringing to the table.

Todd S: It's been a fascinating day and will continue to be a fascinating day with our next guest. Say hello to John Boehm. He's a business unit manager in bioprocessing with Colder Products Company. John, welcome to the show.

John: Thank you, Todd. It's a pleasure to be here.

Todd S: The pleasure is ours, John, I promise. Before we get into a conversation, take a few quick seconds and tell us a little bit about you and your background.

John: Well, my undergraduate's in mechanical engineering, so I spent my career, involved in new product development. Over the last 13 years, I've focused that at Colder Products Company, and I have had a leadership role in the bioprocessing / biopharmaceutical markets, and I've held roles in engineering, engineering management, marketing, business development, and now I'm responsible for a dedicated group of folks that sits purely on the design and manufacture of single use connection technology.

Todd S:  Alright. You mentioned Colder Products. Go deeper on that. Tell us what you guy are all about and how you serve your market.

John: Colder Products, you see a wide range of systems here at the show. We don't do systems. We focus on the connection technology that brings all those systems together. Colder Products has been going 36 years now, and when the very first blood bag moved into bioprocessing, our connector was on the end of the piece of tubing on that bag. We've been selling into this market for a good twenty years now.

Todd Y: This whole notion of single use, talk more about that. Where did that come from and why is it important?

John: Well, single use got its start in media bags and buffer bags that they were making additions to stainless bioreactors. We'll say low cost media that was first introduced. It was an inexpensive and flexible way to bring that product into the process, yet the value of that product was low enough that they were willing to take a risk on a new technology.

Since that time, over the 15, 20 years, we've seen single use go from a minor fledgling piece on just that medium buffer prep, going the whole way now from upstream to downstream, even in the bag system, tubing assemblies, and the final formulation and filling. We're really seeing from cradle to grave on the process, converting to single use.

Todd Y: What's driving that? Why is that happening?

John: Well, there's a lot of advantages for single use. Big picture topics would be lower operating costs, reduced contamination risk, improved production yield, increased process flexibility, but some specifics on that is if you look at the economic advantage, it starts right away with when you're developing a new drug, in today's market, there's a lot of smaller population drugs, not the big blockbusters.

If you need a small volume drug, trying to make that in a traditional large stainless facility doesn't make a lot of sense. You've got to look at your factory differently. If you're looking at a startup, particularly when you think of some of these biosimilars, the generics of the injectables market, manufacturers globally that are looking to get into that, they want to do it at the lowest investment cost.

When you look at the factory, it's much cheaper to build a factory based on single use processing than it is with the traditional stainless. Then, if you also look at speed of the market, a traditional stainless plant might take five to six years to build and validate, where we have examples here in the states, where customers of ours have built an entire new facility, from groundbreaking to validation run, in two years.

Another customer, a contract manufacturer, who has taken an existing warehouse and turned it into a multi-clean room facility in one year, just unthinkable when you look at it from a stainless processing standpoint.

The other part is safety and quality. The drugs have to be safe, so they have an established process on stainless, but with stainless, each time you have to reclean it, and then if you don't get it clean, A, you're sucking up a lot of time and energy cleaning, but if you have a contamination risk and you contaminate a lot, you've just bought all the single use equipment you need for a year, just losing one batch which can be in the millions of a single batch.

The other piece is the operational efficiency is not just the reduced cleaning and labor, but it's reduced downtime. I mentioned the final filling. We have a customer that used to have a filling suite that was fed all by stainless piping, and they would have the process [INAUDIBLE 00:04:38].

When they went to a new batch, it would take an entire shift, almost eight hours, to clean out those pipes and validate the pipes that were clean. Now they're coming in with a single use plastic run, going through the wall into the filling suite, and they can make that transition to a new batch in thirty minutes.

They've got a multi-million dollar filling suite that now is producing all of the time, as opposed to losing shifts at a time, or eight to ten hours, as they want with product transitions. The last piece, which is not very intuitive to many people, is that when you hear the word “single use” or “disposable,” you start to think, “Well, this isn't green.” '

It's really counterintuitive, because plastic processing is actually more sustainable than the traditional stainless approach, and that's because you use less energy, you use less chemicals, you use less water to do that process, and then you don't have to dispose of chemicals, which are actually more difficult to dispose of than single use, because single use is primarily a petroleum-based product that works great in the general waste stream, particularly customers in Europe and some of the states like New York with medical waste. They take that waste and turn it into energy, so it's actually a renewable resource, if you will.

Todd Y: I think I'm convinced. Seriously, when you look through it, that was a long list of value, and each one by itself sounded pretty darn compelling to me. As a package, it's an extremely compelling business proposition. All of that presupposes I know how to design and make the right choices to begin with. Talk us through it. How do I make sure I've got the right connectors and I've put this whole thing together to begin with?

John: Yes, and the thing about the connector is, when you look at a big process and you've got a 3,000-liter bioreactor and you look at a piece of tubing and the connector looks like it's a pretty small piece in that overall picture, but when you understand how single use works, it's actually a really big component in the integrity and efficiency of the process. The reason for that is that, in stainless, it's all one big system.

It's planned and it's permanent, but in single use, you can't make one big system and gamma sterilize it as a whole. You have to make it a sub-portion. That would be pre-assembled and pre-sterilized by a multitude of vendors here at the show, but then when it gets to the end use manufacturer, they've got to bring those pieces together.

With appropriate single use connection technology, you can make those connections in a sterile way, that puts the whole process and keeps it completely closed, maintaining both the sterility and integrity of a complete system, from beginning to end.

Todd S: Tell us about this genderless [INAUDIBLE 00:07:06] G-design. I want to hear more about that.

John: The [INAUDIBLE 00:07:10], we have a range of different sterile connection technologies, and I mentioned how people are bringing this all together. Our [INAUDIBLE 00:07:18] G, it allows a sterile connection to be made in any environment.

The early connectors in this market would typically be done under a [INAUDIBLE 00:07:27] or flow hood, and we fill million of those connections into this industry today. But an ongoing trend is to make a sterile connection where you don't need the INAUDIBLE 00:07:35] flow hood, but you maintain the sterility and safety of that system.

The genderless portion of it really adds to the mix, and that is that it simplifies the design process for the design companies and the process engineers and simplifies integration.

How it does that is, if I'm buying a bag from one company and a tubing manifold from another, I have to know in advance did I get a male connector on this side and a female? By going to a genderless design, you now don't have to think about that.

You know, “I've got a genderless connector on both sides. I can bring any system in, from any supplier,” and they know they're all going to integrate and work together. The other benefit of this design is that it's a really simple, three-step process to put together, and any time you can simplify the process of making a connection, you minimize the risk of operator error.

Of course, that's good in any industry. The other aspect of any connector that we focus on is the engineers are always challenged with make it easy to use, but also make it robust.

If you make it robust, it'll be reliable and repeatable each and every time you make that connection. The other thing, as I mentioned, is that this modular system design that many companies are going towards, is really enhanced by using the [INAUDIBLE 00:08:45] design.

Todd Y: How do you go about validating that you've got the right design?

John: Well, there's a multitude of different approaches to doing that. First and foremost, with some of these very large companies, they don't always communicate too well amongst themselves.

Todd Y: Seriously?

John:  The first step is have you already done the work to validate the connector? Sometimes customers do that by simply taking the validation document, supplied by the vendor themselves, and maybe do a little bit of testing versus we have customers that do a wealth of testing.

One of the things that they often reference is, I mentioned in my intro the Bioprocess Systems Alliance, or BPSA. That organization put together a quality test matrices some years ago, that focused on bags, filters, tubing, connectors, and giving the end users guidance on what kind of testing should you do when you're going to validate these types of products.

The BPSA at that time was a vendor-based organization, and now we've included end users, like Merck and Sonope, and so I'm the lead of the connector subcommittee. This time around, over half my members on that committee were actually end users.

The great part of that is not only did we have the expertise from the supply base, but we have the interactive, before we publish. We'll be publishing here in the next couple months, before the BPSA summit in July, this very updated matrice that we're bringing different sensors and different technologies that weren't part of the original.

That's a great guide for end users, and then the last piece is always you get great support. Go find your supplier, get them involved in your validation. If they understand connection technology, they can really help walk you through that validation process.

Todd S: Now, is Colder Products exhibiting here at Interfex?

John: We are exhibiting.

Todd S: Talk about your goals and objectives here at the show.

John: Part of our goals and objectives is, like I said, we don't make the system, so what we want end users to understand is how can I take these various pieces and bring them together? In addition to our [INAUDIBLE 00:10:42] product that I mentioned, we have a product line called the SteamThrough, and it allows you to make a sterile connection between stainless and single use systems.

In act, back in 2012, it won the BioProcess International Technology of the Decade award. Our goal here, as our president likes to say, it's a plumber's market. Our goal is to bring all the bits and pieces so that you have everything you need to connect the various systems, whether that's a completely single use process, or that's a hybrid system that's a combination of gaining advantage of single use with your existing solid base of stainless.

Todd Y: What's next? What next mountain is Colder going to climb?

John: Well, it's fun, because we've pulled a few engineers back from our design group here to the show, so that they can absorb what's going on, but to be honest, we chose to keep several of them back at home, because we're working on a number of new technologies, and how do we focus on that sterile connection, sterile disconnection, just aiding the adoption and integration of single use?

Today, we have a line that goes from an eighth of an inch the whole way up to one inch, and we just want to keep flushing out the gendered or genderless options that you might have, depending on your preference.

Todd S: When the gavel comes down later this week, at the end of the show, what will John Boehm's key takeaways be, do you think?

John: I think the thing that we're seeing is that this market is truly adopted single use. It's not a talking point anymore, it's not, “Should we do single use?” it's, “How do we do single use?” Our big key is helping our customers, the drug manufacturer out there understand how can they easily integrate their factories of the future and how our technology can help them meet their goals.

Todd S: Outstanding. John, I hate to say it, but we're out of time. Before we let you go, how can people get in touch with you and where can they learn more about Colder Products Company?

John: Well, the first thing you can do is you can go to our website, www.Colder.com/bio, and you can find out about all of our great solutions. If you go on that website, there's always an “Ask The Engineer” piece, and we're happy to answer customers' questions on what kind of connection technology can best help their needs.

Todd S: John Boehm, Business Unit Manager in Bioprocessing for Colder Products, John, it was a pleasure to have you. Thanks for stopping by and joining us.

John: Thank you, Todd and Todd.

Todd S: Alright, that wraps this broadcast on behalf of our guest, John Boehm, my co-host, Todd Youngblood, I'm Todd Schnick, Life Science Connect Radio's live coverage at Interfex. We'll be right back.