Cryoport, Inc. (CYRX) Earnings Call Transcript & Summary

Hello, everyone. Welcome to today's Editors' Series broadcast, Cell and Gene Therapies: Laying the Foundation for a New Supply Chain. This is Agnes Shanley, Senior Editor of BioPharm International and Pharmaceutical Technology, and I'll be moderating today's event. This webcast will explore some of the challenges presented by scaling up cell and gene therapies and how a vein-to-vein supply chain partnership is benefiting them. It is presented by BioPharm International and Pharmaceutical Technology in conjunction with INTERPHEX, the premier pharmaceutical, biotechnology and device development and manufacturing event, to "experience science through commercialization" through exhibits, networking and conferences to leverage quality, efficiency and cost effectiveness. INTERPHEX will take place from April 20 through the 22nd 2021, in New York City. And sponsored by Eurofins BioPharma Product Testing, Honeywell and Lonza Pharma & Biotech. Before we begin, some brief messages from the program sponsors. Eurofins BioPharma Product Testing remains committed to providing its critically valuable, innovative testing services and high-quality data results to our clients during this COVID-19 crisis and remains open for business to support our clients' efforts to get timely therapies to patients. Many of our team members are effectively able to work remotely in line with government guidance. And for those whose work is on-site essential, we've implemented the most stringent social distancing practices to keep our services running proficiently. We are monitoring global developments in our supply chain and are working closely to avoid future supply shortages. We hold the well-being our employees, clients and suppliers at the utmost importance and are practicing government-advised strategies in staying safe during this challenging time. Working together in partnership, we will mitigate the effects of this crisis and help make the world healthier and safer. Honeywell's automation and process controls help life sciences manufacturers maintain auditability and traceability, optimize production and increase speed to market, while focusing on quality and repeatability, data capture, recording and reporting solutions; simplify and safeguard cGMP compliance enabling fast track production, start-up with flexible and scalable systems, insight into upcoming events or delays, easy trouble shooting, remote asset management and embedded cybersecurity; and experienced supervisory controls SCADA system used for electronic clinical trial data collection can be scaled up into a Distributed Control, DCS, System when needed. Lonza Pharma & Biotech provides contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need. From the building blocks of life to the final drug product, Lonza solutions are created to simplify your outsourcing experience and provide a reliable outcome at the time when you expect it. The company's extensive track record includes commercialization of pioneering therapies and manufacturing of a wide variety of biological and chemical drugs. The company continuously invests to solve not just the current but also future challenges. Together, you and Lonza can bring your next medicine to life. Just a few more points before we begin. This webcast is designed to be interactive, and we invite you to ask questions during the event. [Operator Instructions] The slides, which you will be able to download after the program, will advance automatically during the event. [Operator Instructions] And now it is my pleasure to introduce today's speakers. Alberto Santagostino is Head of Cell and Gene Technology at Lonza. Before joining Lonza, Alberto was a partner at McKinsey & Company, where he led the biotechnology service line as well as a pharmaceutical and medical product practice. He has degrees in Industrial Biotech from the University of Milan and KTH Institute as well as a master's degree in business administration from the Polytechnic of Milan (sic) [ Polytechnic University of Milan ]. Amy DuRoss, CEO and Co-founder of Vineti, has focused on health care new business creation for GE Ventures' Healthymagination. Prior to joining GE, Amy was Chief Business Officer at Navigenics, a genomics company sold to Life Technologies in 2012. In addition, she was Co-Founder and Executive Director of Proposition 71, California's $3 billion Stem Cell Research Initiative passed in 2004. She was also Chief of Staff at the resulting state grant oversight agency. Amy holds a master's degree in Business Administration and a masters and bachelors in English from Stanford University. She was named a 2016 Health Innovator Fellow by the Aspen Institute. Amy also serves as a member of the Board of Directors for the ARM Foundation for Cell and Gene Medicine. Mark Sawicki is Chief Commercial Officer at Cryoport. Before joining that company, he was Chief Business Officer at AAIPharma Services Corporation/Cambridge Major Laboratories Inc. Mark has also served in senior business development roles at CMC Biologics and Albany Molecular Research company. He has a bachelors and a doctorate in biochemistry, both from the State University of New York at Buffalo School of Medicine and Biomedical Sciences. Thank you all for joining us today. Alberto, please get us started.

Thank you very much. It's a pleasure to be here today, and it's a pleasure to share this presentation with Amy and Mark. We think that today we have an opportunity to really share our view about how we can drive a vein-to-vein collaboration in cell and gene therapies. It is very important that we think about manufacturing of cell and gene therapies in a holistic way, and this encompasses all the needs that starts from the patient and goes through the logistics, pass through the manufacturing and end up with the patient. And so this is why 3 companies like Lonza, Vineti and Cryoport are actually working together to deliver this approach in a way that is seamless and effective. I want to go into more specifics, if you allow me to do so. In a synthesis, you need to think about the challenge. In advanced therapies and especially in autologous, we are not like in other pharmaceuticals where we are building to stock, where we are producing a drug, putting it in inventory and then consume it as per need. Here, we are really on a real-time manufacturing. It's a completely different ballpark game because we need to think that we are not selling a product, we are really selling time. And we need to really think that manufacturing should be synchronized with the needs of the patients. And it will be extremely important to make things that -- things work smoothly and in a seamless way. To do so, there is an objective that there shall be a smooth transition from interacting with the patients, get the material that is needed, transporting this material in a safe and sound way to the manufacturing center, then address the manufacturing needs, transform the materials into a cell product and then it's delivered back through appropriate logistics and then delivered to the patient. This is an important supply chain of vein to vein that has to be managed in an effective way. Now to do this, there is a need to bring components that goes beyond manufacturing per se, and they need to be effectively integrated to each other because time is of the essence in this case. So a chain of custody, chain of identity, the overall chain of compliance are becoming buzzwords on one side, but extremely important concept that needs to be served effectively. And with the capabilities of the 3 different companies, we are building an integrated supply chain that effectively can serve those needs. So what we are trying to do today is to give you a perspective about how those 3 approaches in these 3 companies can integrate, create a service that would allow to bringing all these new innovative pharmaceutical therapies to patients in an effective manner. Amy, you would like to take this one?

Yes. Hello, everyone, this is Amy DuRoss. Vineti is an enterprise software platform that orchestrates supply chain for these highly complex personalized therapies, providing digitized chain of identity and chain of custody. So we are a Software as a Service that takes a very comprehensive end-to-end approach to give stakeholders who are managing each of the steps in production delivery, as you see here, the transparency and control into each single batch as it makes its way through its process to the patient, ensuring that the right patient receives the right therapy at the right time. So this supply chain that we are all presented with in high-value cell and gene therapies is most definitely the most complex in the history of biologics. And you see on this slide, a typical end-to-end set of process steps for production and all of the red triangles here signify opportunities for risk and error. And so our software in connection with our partners like Lonza and Cryoport, we really stitch up each of the connective tissue, if you will, between the process steps and all the interdependencies in the supply chain so that all of the key stakeholders, whether they sit in manufacturing or they sit in cold chain or they're in care pathway management, have a single view, a single source of truth to ensure that they have the right level of visibility for safety and control of each therapeutic production process. That's what Vineti seeks to do. And we have been built for purpose expressly for this use case and for this marketplace because these therapies demand a new kind of enabling infrastructure that, again, deals with this unprecedented level of complexity.

Thank you, Amy and Alberto, I want to take a few minutes to really talk about the benefits of the Lonza-Vineti-Cryoport partnership as relates to integrated elements that provide efficiency and improvements to the current processes that are available in the marketplace. So as we establish this relationship, we really wanted to look at a couple of significant barriers to current process and optimize those elements. And they tie into 4 specific areas. Area one ties into the visibility of the supply chain and the activities associated with that supply chain, and improving the accessibility of data between partners and parties; to optimize process, which in the current state or the previous state had really been hampered by significant manual and repetitive order entry and lack of visibility on supply chain processes and activities; and on improved communication as it relates to workflow management of that product as it moves from patient to manufacturing environment and back to patient. And those elements, from our perspective, had the ability to have significant optimization due to integrated assets and process-related elements between Lonza, Cryoport and Vineti. The second was optimization of risk and better management of risk. And this occurs through data integrity and analysis, having the ability to automate processes and have the data flow automatically between parties versus having that being done on a manual basis where you have the ability to incorporate error into those processes and improved compliance as it relates to process activities, equipment and optimized activities associated with utilization and other elements. The third is efficiency. And this is one area that has a significant benefit from our mutual client base as it relates to cost of goods. As it relates to time and process activities, we're able to optimize the utilization of not only the facilities related to the manufacturing but also the equipment utilized for both distribution and manufacturing. We're able to eliminate a redundant headcount out of the process, which improves process -- or cost of goods, and we're able to better manage the workflow from a third-party relationship standpoint due to the fact that all of parties -- Lonza, Cryoport and Vineti, all have the same visibility into the processes and systems. And then fourth is securitization of the supply chain itself and better security aspects related to data integrity, related to the chain of custody and the identity. Instead of it being manual handoffs, we're able to automate the processes related to ensuring that the custody and identity is maintained as well as the chain of compliance-related to the suitability of the processes, related to distribution and the automation of many of these processes. So these were the key elements that we were looking at as we worked to establish this relationship. And as we transition, I'll turn it back over to Alberto to have a conversation as it relates to the partnership and some of the goals and standards from the parties. Alberto?

Many thanks, Mark. So as Amy has explained, there is a great degree of complexity that involves a significantly more challenging supply chain and manufacturing setup than any other previous biologics and manufacturing, and this needs to be acknowledged and this needs to be addressed effectively. To do so, each of the 3 players that you see on this slide bring unique capabilities that jointly can actually solve the problem in an effective way. So the idea, which is pretty simple, but as much as effective is the integration already upfront between our 3 organizations in the processes and in the way of working, such that this could become a seamless way that can be delivered to customers and clients to deliver effective pharmaceutical to patients. Each of our organization is extremely strong in the path that they cover. So you have Cryoport being a global leader in what I would call the hard part of logistics with their container and the actual shipment. You have Vineti that is an effective leader and the most important one in terms of orchestration and management of the data. And then you have Lonza that is an end-to-end CDMO that has experience in manufacturing and bringing clients from process development to commercial setup. Integrating those capabilities and working on the strength of the company allows to create this integrated supply chain that allows one phase and one process toward the customer. That's the overall philosophy, and we will now go into the details of explaining how each of our organizations do contribute in making this possible. If we start with Lonza Pharma & Biotech, our fundamental aspiration is to industrialize cell and gene technologies into a way that allows us to transform what was a science into an actual industry and I would say, a commercial supply of effective drugs. If you look at Lonza, as a general global organization, it's one of the leading CDMOs with a significant presence on the market, and we are serving each of the possible relevant modalities that do exist. But we are particularly invested in the cell and gene technologies, which we envision to be one of the key pillars for the future of medicine. If then we look at our vision, we really want to enable smaller companies and larger companies, what we call trailblazers in cell and gene therapies, with the ability to focus on their science and to focus on their patients. And we can take care and we want to take care about all the technical developments and the manufacturing aspects that are needed to support their vision to bring drugs to the market. So we have a global footprint that covers the 3 continents. We are addressing all the modalities that are relevant -- autologous, allogeneic, viral vector. We have leadership in terms of innovation with several of our devices or innovation in terms of process and analytics, especially also in aspect of characterization. We do focus in developing and development of the processes of the companies that do want to relate with us, and we have a focus on manufacturing and GMP manufacturing at scale. If we consider those elements, we have, in particular, manufacturing network that was to cover the 3 geographies. We have 4 main sites: 2 in the United States, 1 in Europe and 1 in -- and 2 in Asia. And in the 2 in Asia, 1 is our own site and a collaboration with Nikon in Japan. If we then look at one of the other important aspect that we contribute to the table in terms of manufacturing, it's also the aspect of the next-generation data management, which means that it's important to get organized to manage data, not anymore on paper, especially in the context of cell technologies. The number of batches that are to be manufactured is going to exponentially grow with the growth of the service to the customer and to the patients on the market. If you think about biologics manufacturing in terms of monoclonal antibody or any other product that is built to stock, the number of batches is significantly smaller than the number of patients. In the case of autologous manufacturing, every patient is a batch. And if some of our main industrial sites in biologics manufacturing is delivering hundreds of batches in cell and gene technologies, we are preparing ourselves to delivering thousands or tens of thousands of batches. This makes paper completely impractical, and we are moving toward a completely virtualized data system and track and trace on the shop floor that allows to avoid mistakes, to avoid repeated data entry and to make sure of integrity of all the operations that are done on this floor. These systems are effective in every terms of manufacturing and are integrated within the data system provided by Vineti and Cryoport. If we put it all together in a holistic way, this is how you should think about the integrated supply chain. Let's start with the patients. It requires a collection. It has an important logistics that needs to be done effectively with the means of transport and all the containers. Then there is the important piece of manufacturing that needs to happen in effecting GMP setup. And then there is the logistic back, that needs to go back to the patient for the appropriate transplantation. And all this needs to be or orchestrated in an effective way, with appropriate data management that ensures chain of custody and chain of identity. Each of the 3 organizations takes care of a piece of these overarching supply chain and the integration of the activities of the 3 companies allow to have a one effective system to deliver to the need. If we then specifically look into Lonza, our supply chain solution, our path to manufacturing is ensured by 4 elements. The first one is a global tech transfer that allows us to have the same manufacturing performed in each of the continents in each of our sites the second aspect is the MODA which is a shop floor traceability platform that allows to make sure that operation is instituted effectively and to batch specification, reducing error and to make data management much more effective. Then we have the aspect of the manufacturing and GMP manufacturing at scale. And finally, there is a shipping logistics in terms of global supply. And for these 2 final aspects the collaboration of Vineti and Cryoport is essential.

Thank you, Alberto. In continuation of discussion, I'm going to provide a brief background on Cryoport as it relates to the space and obviously, this partnership. So Cryoport as an entity -- is the market leader in the space of distribution of these types of therapies. We're currently supporting 465 clinical programs, including 62 Phase III and 3 commercial products. And our whole focus is related to the management of risk as it associates with the distribution of these therapies. And as part of that management of risk, we have found it to be critically important to integrate the packaging, logistics and informatics aspects into a single data stream to better understand the propensity for uncontrolled events in the field due to third-party handling of the equipment associated with distributing critical life-saving therapies that are irreplaceable. So part of this is tying in and really looking at a platform that is integrated in understanding and managing that risk and developing technologies and competencies to understand that risk, and to better predict and eliminate failure events from occurring in the field. And this ties into automated and rigorous process management aspects, automated monitoring, using an informatics platform that provides the ability to understand and control all of that data from a historical sense, continuous requalification of all the equipment associated with distribution of these types of therapies, and then the storage and consulting functions, which better understand the client need and allow us to respond to that need over time. One of the key elements that we've looked at is implementing and instituting procedures, processes associated with equipment and handling of these elements that are similar to a GMP manufacturing environment. And this is actually reinforced by the recent notice and issuance of the new ISO 21973 standard, which also recommends traceability as it relates to equipment and some of the processes associated with that distribution of these types of therapies. And this is an area that we have focused on pretty heavily as an organization. The 2 areas that tie into that are -- one is what we call advanced therapy shippers. And these are a segregated platform associated with distribution of cell and gene space, using dedicated segregated standards and validated cleaning methodologies to better manage risk associated with distribution, with equipment performance and with cross contamination. And as a final example, one of the elements that we have recently launched is what we call our Veri-Clean or validated cleaning and disinfection process. And this is one example of better managing that risk in the field by getting the equipment that's being used to distribute life-saving therapies into as close to a sterile environment as possible from a production and distribution standpoint. And this ties back into that risk management process overall. So with that, I will turn it over to Amy to kind of talk through the supply chain aspects of this.

Thanks so much, Mark. Hi, everybody. So one way to think about how we intersect with these excellent specialized partners who offer both technologies and services is that we really serve as the smart plumbing, if you will, that provides that chain of identity and chain of custody linkage among all of these service providers and stakeholders who drive process. Alberto said something very interesting earlier around selling time. We also, in addition to time or selling hope, our company, Vineti, was expressly founded really with the ultimate vision of extending these high-value therapies to all patients. We're very motivated by that mission and understand a means to achieving that mission is standard setting. The standardization of the supply chain will allow for optimization and also respecting the core competencies of key ecosystem partners like Lonza and Cryoport to really perform their piece of the chain. And to help them optimize their piece of the chain is a big part of Vineti's value proposition. So the really interesting thing, in addition to, of course, all of the compliance pieces that are required and a system like Vineti is expressly required by regulatory authorities for commercial-grade therapeutics in this field. It's also incredibly important to have this orchestration and control and transparency in clinical phase. So we serve both clinical and commercial therapies. A quick snapshot about our company. We're just over 4 years old. Our team is a real hybrid of deep enterprise software expertise, deep cell therapy manufacturing expertise, big pharma services and also really innovative sort of mid-stage biotech companies like Kite Pharma who was our first partner in the marketplace. This slide will just also seek to intersect again with our partners who came before in this presentation. But what you see here in front of you is a schema that shows Vineti in the center. All of the chevrons in the middle really reflect typical process steps for single batch production, and this is where Vineti seeks to be integrated and control chain of identity. What sits on the outer concentric circle are all the other systems of record that we, via integration, connect to and exchanging data but also optimization. So you can see here the alphabet soup of all the various systems, including those of our partners you've just heard from, are really seamlessly combined into a single source of truth, so the right data is received at the right time for the right stakeholder who has to drive their piece of the chain. Vineti is a young company, but very much on a steep upward trajectory. We're really proud of our growth, all driven by our phenomenal partners in pharma as well as ecosystem partners like Lonza and Cryoport. We are continuously learning every single day. Our team is now north of 125 people. We're based in San Francisco, but we have offices on the East Coast of the United States as well as in Armenia and Canada, and we're growing very, very rapidly in this incredibly important time for growth for our market. One last quick point that I'd like to make and it may well come up in some of the Q&A forthcoming here is back to this important sort of standard setting, the company was founded with the premise that without standards, we can't optimize. And we recognize that -- again, if we're going to achieve Vineti's vision on behalf of the market, which is to extend access to patients, that we're absolutely going to have to cooperate among the ecosystem players to really get to fine grain standards so that we bring cost of goods down, we drive efficiency, we increase (sic) [ decrease ] turnaround time so that we can save more patients. So we play a lot of roles in the marketplace. We do sit on a standards coordinating body that is sponsored by FDA here in the United States. We spent a lot of our internal time with our product teams as well as our interactions with pharma and ecosystem players to really align on standards. And now we know more in 4 years, and we'll know yet more in the next 4 and 8 and 12 years about what is needed to really make sure cell and gene therapy becomes a proper industry. Today, we are on the journey to that outcome, but we have a lot more work to do and the way we accomplish that is to set standards in collaboration with our partners. It's very exciting to have the quality of partners like Lonza and Cryoport who share and are aligned with the same vision. Thank you. I'll pass it over to you, Alberto.

Then let me bring all these together and explain the overall vision that these 3 partners -- Vineti, Cryoport and Lonza, are trying to realize and bring forward. And if we take the distance and we look at the overarching situation, we have a complex setup that needs to be addressed, and we are trying to bring together a simple solution. If you think about the complexity of bringing a drug to the market, all the clinical challenge and all the science, the aspect of the technical development, manufacturing, the interim supply chain and especially the scale-up to a high number of patients can be pretty daunting. This partnership is intended to take a good control and create a good solution for the technical side of bringing a drug to the market. So from early companies to late-stage companies growing through and with the companies, offering a solution that is scalable, that is able to address the overarching supply chain and transforming what is a risky complex supply chain from vein-to-vein with a more simple standard technical offering that can be as much as plug and play, and as much as tested and working in multiple customer situations that allows to simplify and streamline at least one aspect of developing a drug. If you go into the specific benefit, there is a collection of several elements that are of value. So we have an elevated compliance with systems and process and procedure and manufacturing approaches that are tested and are validated by regulators even at commercial product release. So companies can walk again in the same path that has been successful for the previous companies. We can reduce time lines because all those systems are standardized and tested. And so we can avoid a big part of validations of those very same systems. We can have real-time visibility of all the data moving away from the classical paper-based way of managing data that is typical of pharmaceutical, and going into a data and the data availability era. We can reduce cost, waste and reduce risk and error just simply because all those systems will enforce a more mechanistic and standardized way of doing things that repeating themself will just allow a better outcome. We can access extensive expertise of the 3 organizations that have been serving multiple customers and pharmaceutical companies ahead of time and you can leverage and tap into those experiences. And fundamentally, you can save time and effort internally to try to piece together a solution that were not thought to be integrated initially. So what we are trying to do as a vision is fundamentally derisking and simplifying the technical development part and the manufacturing supply chain with an integrated solution that address all the aspects that up to today were not effectively integrated. Hopefully, this has provided a good overview about the vision and the intention and about how the 3 companies work together. I would like to thank you for your attention, and I look forward to your questions.

Thank you all for the presentation. It's now time for questions and answers. [Operator Instructions] I had a question for all of you. With any cell and gene therapy developers today, maybe pushing through with their existing IT and other systems and tools that were designed for traditional biopharm products, where will problems typically first show up in this approach? And how should developers be thinking about the infrastructure needs they'll have from the very beginning?

Well, if I need to give a perspective on these aspects, I guess there are several pain points that will become immediately visible. The first one is just no system is really thought for just-in-time and real-time management. And this is a supply chain that have rules of the games that are completely different. So most of the pharmaceutical manufacturing is thought and tailored for manufacturing to inventory. While here, we are playing against a manufacturing just in time. And if an orchestration doesn't happen effectively, this will just simply not work and would compromise safety and life of patients. The second aspect is definitely in the quantity of data management and the repetitivity of the manufacturing. We have 1 or 2 orders of magnitude more batches and doing things in the old way is just simply not feasible. It would be overwhelming and excessively costly. So I doubt any existing solution would be able to deliver against the needs of commercial scale manufacturing. There is the desire or potentially the attempt to try to develop a solution -- kind of home developed solution, but those ones will lack, how can I say, the experience and the scale and the validation that a solution that is used across multiple player would have.

Amy, would you have any other...

Sure. Yes. I concur with Alberto's points. I would also add how important flexibility is in this particular use case for cell and gene therapy. And not just because there's so much inherent complexity in each protocol, but often there is a diversion from the protocol. And so I think the ability to, in real time, adjust and adapt to ensure that the process is -- the fidelity of the process remains intact is really important, and we're seeing a lot of learning on this front in real-time with our partners. As a software company, the investment we've made and the ability for our partners to configure as opposed to creating whole new custom code lines every time there is a change in protocol or for exceptions, in particular, since often exceptions are the rule in this marketplace, is something that really does add unnecessary time and cost into the system. So the ability to have a best-in-class, truly enterprise-grade platform where you have far more control over how your workflow is implemented and then how it evolves. Because even in commercial phase, these therapeutics are continuing to evolve their requirements not just from a regulatory standpoint point, but from a process standpoint. So the ability to iterate and do it in a cost-effective way is really important in many of the existing -- particularly the IT tools. Many of the existing IT tools are just -- just don't have the horsepower to support that kind of complexity and change.

Okay. Now several of you mentioned the need for standards. And it's very early now but I wondered what you were expecting to see from regulators in the future. And particularly, Mark, regarding cleaning validation practices, container and shipment requirements for cell and gene therapies, where do you see existing practices and technologies being inadequate to the needs of this new market?

Sure. Happy to answer that. So the industry has been working for the last 3 or 4 years on future state regulatory recommendations. In fact, as I had mentioned earlier in the discussion, there is a new ISO standard that was just published within the last 2 weeks, which is 21973, which outlines some of the progression in requirements associated from a -- or recommendations from a regulatory standpoint as it relates to the manufacturing and distribution of advanced therapies. From our perspective, there's a couple of key elements that tie into this. One, as I mentioned prior, is the ability to incorporate full traceability in the management of the equipment that's being used to distribute the therapies. And this is due to the fact that this equipment is all -- it's not single use, it's equipment that gets reutilized due to a cost basis. And the requalification processes associated with that are critical to ensure that you don't have a failure event occur in the field. And the second is there are also enhanced cleaning recommendations in regards to traceable validated cleaning processes to reduce the risk for things like cross contamination. And then moving forward, we're also looking at trying to implement other technologies to reduce risk on a predictive basis, looking at trend analysis and equipment performance and using things like AI to predict the likelihood of a unit failing, for example, prior to it actually occurring, so that you can prevent that from happening in the future. So there's quite a few things that I think are coming out of that from a regulatory standpoint that we're thinking about.

Thank you. Any other insights?

This is Amy speaking. I would add just perhaps a more mundane standard but one that's absolutely crucial, in addition to some of the technological advancements that Mark referred to, is a universal convention around label template. There's lots of cross-border travel of these therapies and multiple manufacturing sites that serve multiple markets. And the headaches that are caused because of different labeling conventions in different marketplaces, even in the same continent introduce unnecessary risk. So both what is on a template that would serve a universal purpose and then how those labels are procured. We see a really important opportunity for movement to an on-demand printing capability as opposed to pre-printing and pre-shipping labels, which does occur today in the market. And again, we think introduces unnecessary risk. But Vineti has been tasked by the standards coordinating body that was sponsored by FDA to really dig into this item in particular with other colleagues in the ecosystem to recommend what that template should be and how it should be procured. It seems mundane, but it's absolutely crucial to chain of identity and to ensuring safety and reliability.

Yes. For autologous products, how is your partnership addressing the challenge of scheduling and the variability in incoming material quality?

This is Amy. I'll kick off. I know Alberto has lots to comment on this topic as well. What is fundamental in autologous therapies is that for the first time ever in the history of biologics, GMP process has been extended into clinic. So the care providers are implicated in a manufacturing process in an unprecedented way. So that's where -- in clinic is where the chain of identity is triggered. And obviously, that causes a cascade of effects moving the therapeutic into production and delivery. And so that level of input and then how the care providers interface with a system like Vineti to ensure that there is a secure manufacturing spot on the other end of a collection -- a cell collection step is really important. And while it might seem trivial, it's actually very difficult to optimize and make sure that we're getting the level of efficiency and control so that we are tightening the time frame for production as much as possible and ensuring that patients don't have to wait unnecessarily for their potentially life-saving therapy. So that connection between collection of cells for an autologous work flow and then really telegraphing into a secure manufacturing slot at Lonza, for example, is a key first initial chain of identity step that enables everything else that comes later.