Quality Grind Podcast

Technology Transfer Part 2: Contract Partner Collaboration

• MEDVACON Life Sciences • Episode 12

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In this episode of The Quality Grind Podcast, host Mike Kent continues the Technology Transfer series with Kim Lim, as the two illuminate more strategies for achieving successful collaborations between sponsor and contract partner organizations. Key discussion points include assessing the true capabilities of potential contract partners, the importance of early-stage technical reviews, and why relying solely on a Quality audit can leave sponsors with a potential false sense of security. Learn how CDMOs can differentiate themselves and help accelerate the development process.

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Quality Grind Podcast Ep 12 - Technology Transfer Part 2: Contract Partner Collaboration - Kim Lim

Jessica Taylor: [00:00:00] This is the Quality Grind Podcast presented by Medvacon. Conversations that go beyond compliance. Sharing insights geared toward helping you navigate the everyday grind of regulated life science industries. Here are your hosts, Joe Toscano and Mike Kent.

Mike Kent: Welcome back to The Grind, everyone! In today's episode, Part Two of our Technology Transfer series with Kim Lim, we continue to explore what goes into a successful collaboration between sponsor and contract partner organizations. We talk about how CDMOs can set themselves apart, not just from a technical standpoint, but as a key partner that can actually accelerate the development process and improve the science.

To this point, we've focused on how sponsor companies should begin preparing for tech [00:01:00] transfer early on. First, outline your development life cycle, clarifying who should be involved, roles and responsibilities, process steps, key stage gates, and other decision points as they've been defined and agreed to up to this point.

Kim noted that Quality by Design as described in ICH Q12 is becoming much more of a regulatory expectation than just a suggested best practice for development activities. And Kim strongly encourages engaging contract partners way earlier than you think, including having them be a formal part of your Development team. 

My conversation with Kim picks up with how sponsors can more effectively assess the true capabilities of a potential contract partner. Again, by digging in a little deeper and a little earlier than what might be considered typical. Let's get back to it [00:02:00] here on The Grind.

Jumping ahead now, you mentioned it's important to really understand the capabilities of your contract partners and whoever is really providing you with what you need in order to be successful through this process. Does that include suppliers, other vendors that are providing you with what you need in order to support that process as it moves forward? And I guess the most important question of the two I'll ask at this point is, how does a sponsor go about really assessing the capabilities of those partners? 

Kim Lim: As in many things in the industry, things default to the Quality audit, right, when a vendor gets audited by Quality. And there are things that you can do early stage on with a technical review or technical assessment of a [00:03:00] vendor and to see what their capabilities are.

And my biggest suggestion in this area is talk to the people who actually do the work. If you're looking for them to do analytical testing, talk to the director of the analytical lab and say, "Hey, I'm interested in doing these things. This is my product. This is what we want to do. Is this something you're capable of helping me with?" If it's a manufacturing facility, talk to the manufacturing engineers and talk to the operators on the floor. "Have you seen this before? Can we do this with our process?" 

I don't dispel that business managers and business relationship managers are great and they sell the services, but you really need to get to who's actually going to touch your process and are they capable of doing that. I know that there is a vendor that I had spoken to, to vet out for a particular process for a client of mine, [00:04:00] and we sat there for two days talking to a technical individual. Their sole job was to understand all the capabilities of the different sites that they had across the U.S.. And he could definitively talk to you about, "Yes, this I can do this for us. This I can't do this for us. This is how I would approach bringing your product into our manufacturing process." He was very knowledgeable and that's the kind of person that you want to talk to, to really understand the capabilities of what your vendor is able to supply to you.

And you also want to get a good sense of how they're sourcing their vendors, right? Where are they getting their materials from? What kind of business continuity do they have? That's very important now, very, very important given supply chain issues that we've had since COVID. 

So, those are all practical [00:05:00] tips that I can impart on you. Really communicate with the technical expertise, even if you have to dig into the director level or even the supervisor level in the company. And then also really understanding how they're sourcing their vendors and what their business continuity looks like.

Mike Kent: Yeah. Because if you don't know specifically what those materials or processes or even the piece of equipment, pieces of equipment, the materials of construction may be different and may be either advantageous or not to your product or your process. And all of a sudden things are different and you're not sure whether it's they don't have the process dialed in or it's something else. 

So those next level questions, I can see the value in those that you're proposing. Is this best done, well, let me just ask the open ended question. How is that [00:06:00] discussion and that evaluation best conducted? Is that in person? Is that virtual? Is that mail order questionnaire kind of thing? What sort of strategies work really well? 

Kim Lim: Sure. I think you start with the business relationship manager, having a conversation over Zoom, over the phone and going through your laundry list of things that they can and cannot do for you. Kind of going through that risk assessment of, you know, if we choose this person, what can we get for that?

I do recommend if you narrow it down to two or three vendors that you think are a good fit for your organization, to go visit them and talk to these people in person. Go see their facility. I have been in these kind of technical assessments before where we're getting ready to transfer a process. We've got it all dialed in and then we get there and they say, "Oh yeah, [00:07:00] we're totally capable of doing your manufacturing process," and there's nobody working there! You know, they have all the machinery, but they don't have the personnel. And it's, they're waiting for that first customer to come in to employ these people. So I think those are those important scenarios that you got to see. 

We also went and visited another facility, you know, very well known entity. We go there and their equipment is ancient. They're not up on the latest technology. They probably have bioreactors from the 1980s. And it was, it was astonishing to see! 

Mike Kent: Hey, wait a second... 

Okay. [00:08:00] Here we go. 

Kim Lim: There is a mentality if it's not broken, then don't fix it. But there is definitely some, uh, advances that have been made that, you know, it would be nice for your partner to be up to speed to the newest and greatest, and offerings for them. 

So I think it's well worth to see their facility, talk to the people on the floor, even the condition of the facility, right? If you're going and doing a tech transfer to somebody who's going to maybe go from the 50 to 250 liter bioreactor, it's unsightly to see electrical cords all over the place or equipment on the floor or, you know, spills or not a good flow for documentation. I mean, that, that's a big one, too.

So, just to see things in action and see people working. That [00:09:00] probably will speak volumes to you just right there.

Mike Kent: Is that something that an auditor, a skilled QA auditor can do? I imagine the answer to that question is yes, but let me pose something else. Is there additional value to having technical folks, the subject matter experts from the sponsor, actually be a part of that on-site visit? 

I know it's expensive. I know it's time consuming, et cetera. But I think of my own experience as an auditor, and maybe you can talk to yours as well, that if we go in for a day or two, we can only see so many things. Our perspective sometimes is narrower than maybe it should be. We don't have the benefit of all of that development expertise in the back of our heads. So the questions we may ask may be good questions, but they may not [00:10:00] be the great questions. The one or two that really make the difference to assess whether these folks can and should be chosen to do this important work for us. 

Kim Lim: Oh, no, you're totally on track. And I would even say, even before you got QA involved, have these technical assessments done with the SMEs. Really just have the AD person talking to the AD person. Let's talk, you know, the CMC head talk to the manufacturing engineer that's working the process. That is more valuable information before even Quality gets involved to schedule an audit. 

And funny that you say that. So, it happened to be that I had a client who did technical assessments and they were really pressed for time, so I ended up doing an audit right after the technical assessment. And I said, "Hey, you know what? I'm going to just come that week and I'll go through the technical assessment [00:11:00] with you just to observe," and then they could come and observe during the Quality audit.

It was a wealth of information. So we got the A team of the manufacturing supervisor who have been with the company for 20 years, went through all of the process, went through the entire facility, such a great facility tour, answered a ton of technical questions. And then when it came to the Quality audit, we got like the B operator who barely knew what Downstream was in the process, and really just gave a very, very light facility tour through the facility, like going from the warehouse to the manufacturing area, very, very light. 

So I think you can glean a lot of information from a technical assessment that you might not see in a Quality audit. And it's well worth to do that work up front with your SMEs than to involve Quality in the process [00:12:00] and spend the time and the money to do an audit when these people may not be the right fit for you as an organization.

Mike Kent: That's an absolutely great point. To that end, balancing all of this, we get it. We understand tough decisions have to be made. But it sounds like what you're saying, Kim, is the value of making some of those maybe more expensive decisions up front, but when you get to a point where you're ready to commit, having so much more useful frontline information and firsthand experience is going to serve you much better than relying on a paper questionnaire that gets filled out and sent back saying, yes, we can do whatever it is that you want.

Kim Lim: Yeah, well, and not to be... not to demean any process whatsoever, but it's kind of like dating, right? So you have to kind of talk to these people, get to know these people before [00:13:00] you get into a relationship. And then, you know, eventually you're going to be in a long term marriage with these people and you're going to have a contract with these people.

So, you know, doing that early vetting on of "what do you like, what don't you like, what can you do? What can't you do?" Like that, it really serves you a lot in the beginning.

Mike Kent: Who knew you could get dating advice here on the Quality Grind Podcast?! In addition, if you needed any other reason why, there you go, it's the same thing. I absolutely love it! 

So in the spirit of relationships being 50-50, let's talk a little bit about

Kim Lim: Sure.

Mike Kent: the CDMO side or the contract side. You've started, operated very successfully, owned your own contract laboratory. From that experience and your experience working with CDMOs, Contract Development Manufacturing [00:14:00] Organizations, what are some pitfalls that contract organizations fall into not intentionally, but just by nature of this process? And what are some things that those organizations can do to, I don't want to say entice, but can do to make that process more of a meeting halfway and really make it successful from their perspective?

Kim Lim: I'm going to speak to my experience. You know, this was the secret to my success is listening to your client. Understanding what their needs are, what their wants are, what their absolutes are, dis-swaying any assumptions, you know, communicating, communicating, communicating. Understanding what their expectations are, documenting these expectations, and getting them to agree to a [00:15:00] Quality Agreement with you. It's super important. And I think being upfront with them about what you can and cannot do. 

So, those are pitfalls I think a lot of contract organizations do. They want the business. They want it very desperately. Let's just tell them we can do everything. Maybe we can outsource it later on, or we can figure out how to do it in the process. But I think, in the long run, honesty is the best policy. If you can't do something, just tell the client that. And, you know, I've always had a back pocket of partners that I work with that I think could do these things that I couldn't do as well as they could. So at least having resources for them available. 

So I would say the biggest, biggest issue and the secret to what we did was listen to our customer and really understand what their problem is. I think as a business [00:16:00] manager, you're kind of trained to do that. And then knowing who your technical experts that can come in and answer those questions for your customer is really key, too.

So you can't live in a vacuum in the sales world. You have to know your organization very well, too. I think that's really the crux of it is the communication.

Mike Kent: Yeah, it doesn't seem like there's a lot of positives that come out of "say yes and then figure it out". "Um, well, we've got seven months before their slot in our manufacturing process or our manufacturing schedule. So we've got seven months to figure this out, let's get on it." Really doesn't sound like a sound strategy.

And I couldn't help, but go back to the dating advice. I just, everything just kind of resonated there as well. Are we talking tech transfer in regulated [00:17:00] spaces or are we talking about dating? I lost track. I think it's both, which is great because again, we're giving people hopefully a little bit more than what they bargained for when they signed on. I think that's fantastic! 

But really, you know, being honest and transparent, and I think you mentioned it as well. As consultants, we run into the same sort of challenge in that we're always looking for good, interesting work. Having that awareness of, all right, I can't. Or, I can't meet all of your expectations, what can we do, and here's our network of trusted partners and making those available and facilitating those discussions. Everybody wins. 

Kim Lim: I think collaboration goes a long way with customers. So saying that you can't do something, but you know someone who can, [00:18:00] that means you're really solving the problem with them instead of just taking on the work for them. So again, I know this is going to be splitting hairs, but that's the difference between a contractor and a consultant, right? A consultant is the one who comes in to impart knowledge on you and a contractor is just there to work for you. This is the value that a consultant brings to the table. 

Mike Kent: Absolutely. Well, we've covered an awful lot from the preparation and getting ready for success. I'm going to give you one more opportunity before we start looking at the execution of this process down the line. What are some things that we haven't touched on in the preparation to this point? You mentioned quality agreements, you mentioned communication, you mentioned getting involved early on as possible in that process, having different roles involved from both sides coming together. What [00:19:00] else should organizations be looking at from either side, really to make the preparation for starting the actual transfer process a success?

Kim Lim: A big item, too, is gating. So really understanding what point in your discovery and development process you need to be in order to do the tech transfer, right? So that comes from both sides. Being honest about where your science is at and where you're going to be during the process of tech transfer. And then from the contracting side, being very upfront of what you're able to take on as as a state that the science is in, right? So if it's a small molecule, we've got the compound now, we've kind of gone through a little bit of the small scale development process. Okay. Now we're going to bring it over to your facility. I mean, you can't bounce it into a full scale manufacturing facility.

[00:20:00] So, I think it's the contract entity that really needs to tell you like, "Oh, okay, so you know what, we need to do some engineering runs. We need to do some small scale runs to see how we're going to do this in a large scale." So, again, really having that communication of expectations between the 2 parties of, okay, I'm going to bring the science to this point and now can you take it from there? Or, I can't take it from there and let's go back to the development board a little bit more or an interim step that we need to do together. 

Mike Kent: It would behoove organizations really to have a sense of what their development process may look like. It doesn't have to be defined

Kim Lim: Sure.

Mike Kent: in 412 SOPs and all that sort of thing. But what I'm hearing you say is have a framework. Have an understanding of where those key points in your development life cycle are that you're going to need to make decisions and make key decisions at. And then engage your [00:21:00] partners in helping you make those decisions and that will advance the entire

Kim Lim: Absolutely.

Mike Kent: program. Do I have that right?

Kim Lim: You do. do.

Mike Kent: Woohoo! Blind squirrel theory strikes again. There we go. I'm just glad I can keep it all straight. I mean, you're the bioengineer for crying out loud. I just extracted stuff out of biomass and threw powders in a jar and spun them together.

Kim Lim: Well, you made something right? Ha ha ha ha ha ha ha ha ha ha ha ha ha.

Mike Kent: Somebody liked my work at some point, and not to demean chemists at all. I'm right there with you, my friends. 

So we've come to the end of the planning and preparation phase, not an insignificant undertaking, and easily the most critical determinant of success for technology transfers. Let's highlight some of Kim's key points from the CDMO's point of [00:22:00] view. 

Make sure your technical experts and operational staff are available early on to facilitate transparent discussions around your capabilities and ability to meet the sponsor's needs. Invite the sponsor's technical team out for a site visit so they can see your practices and processes in action before the quality audit takes place. 

Provide clarity on how you manage your own suppliers and vendors, as well as where and how those may be needed to be engaged based on what the sponsor needs. Along with that, share your business continuity plans to reassure the sponsor that known or predictable issues have been thought through and have prevention and mitigation strategies in place. 

And lastly, listen, collaborate, and seek to understand more than securing a signed contract. That may sound a little wishy washy, but if [00:23:00] you focus on building a partnership based on shared expertise, mutual respect, and genuinely helping the sponsor solve their challenges, especially as they progress through the development phase, the end result is always a more robust and successful tech transfer.

In part three of our series, Kim and I discuss critical strategies and tips for executing a successful tech transfer and how to put all of your diligent planning into action. We hope you'll join us for that and more, next time, here on The Grind.

Joe Toscano: If Medvacon can help you and your organization, we're happy to do so. We specialize in the following areas: Quality and Compliance, Validation and Qualification Services, Project Management, Tech Transfers, General and Specialized Training Programs, Engineering Services, and Talent Acquisition. If you have general questions as well, feel free to give us a call at any time.

We can easily be reached at [00:24:00] 833 633 8226 or via our website at www. medvacon. com. Thanks so much, and we look forward to speaking with you. 

Jessica Taylor: Thank you for listening to the Quality Grind Podcast presented by Medvacon. To learn more or to hear additional episodes, visit us at www. medvacon. com.