Name:
Manufacturing mesenchymal stem cells: an interview with Mayasari Lim
Description:
Manufacturing mesenchymal stem cells: an interview with Mayasari Lim
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Duration:
T00H16M22S
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https://cadmoreoriginalmedia.blob.core.windows.net/780d1e02-50a1-4431-942d-19a521050a69/Mayasari Lim - Interview V3-1.m4v?sv=2019-02-02&sr=c&sig=3%2B3ekFhLY7RPSKgT2QOP5VaNCLZ5qrHWfZN7VpmhzgY%3D&st=2024-05-06T23%3A20%3A10Z&se=2024-05-07T01%3A25%3A10Z&sp=r
Upload Date:
2020-11-09T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
[MUSIC PLAYING]
MAYASARI LIM: I'm Mayasari Lim, and I am the Technology Evangelist for RoosterBio. So my job is to help our customers succeed at what they do by sharing our knowledge and platform solution. So RoosterBio supplies high quality off-the-shelf human mesenchymal stromal cells and media products to support regenerative medicine product development. Our engineered bioprocess hMSC media produces the industry leading performance that really has put RoosterBio on the map.
MAYASARI LIM: Over the past seven years, we have grown our business to serve over 300 customers in six different continents. And we're very proud to be working closely with researchers and product developers in the cell and gene therapy, extracellular vesicles, gene editing, tissue engineering, and medical devices fields. Our goal as a company is to fuel the rapid commercialization of scalable regenerative cures. [MUSIC PLAYING] The biggest advantage in using commercially available large-scale cell banks such as those that are supplied by RoosterBio is really the convenience significant time and cost savings, and also really the support that our customers can benefit from by working with us.
MAYASARI LIM: So we often like to parallel this to the semiconductor industry. Imagine if you were a smart device manufacturer and you had to build your own microchip before you make your device. This would take years of development time, tons of resources, and money. Thus, setting you back at least two to three years before you can launch your product or device.
MAYASARI LIM: So we see human MSCs as a piece of technology similar to a microchip. And therefore, by industrializing the supply chain of human MSCs, we standardize well characterized cells paired with highly productive media systems. We're radically reducing these product development timelines for cell therapy manufacturers and product developers so they can focus their time and resources on final product application.
MAYASARI LIM: Additionally, for our cGMP cell banks, we provide the supporting master files that will go with their I&D filing. And therefore, this significantly reduces the regulatory burden that they have for their source materials. We also have multiple GMP donors that are fully characterized, readily available for them to select from.
MAYASARI LIM: This eliminates the need for them to screen or prescreen and find suitable donors. And therefore, reducing their risk in creating cell bangs that may not have the quality or performance that they're seeking. [MUSIC PLAYING] Extracellular vesicles are being investigated for a wide range of therapies, from bone fracture to wound healing, and even myocardial infarction.
MAYASARI LIM: So as they're acting as a bioactive agent, the key advantage in using extracellular vesicles is that you don't have to deal with the complexities of a viable product such as cells. This significantly reduces or simplifies the cold chain logistics, gives you better stability, and a better safety profile since you're no longer introducing in living cell. In many ways, it is making cell therapy easier since the product is no longer a living cell, but a secreted molecule.
MAYASARI LIM: Additionally, in the case of folks who are developing MSCEV therapeutics, we are leveraging the knowledge of what we already know with MSCs in clinical trials to harness the potential of MSCEVs in regenerative medicine. And many studies have already shown that MSCEVs have similar regenerative medicine-- regenerative capabilities to the native cells. However, we are still in very early stages of understanding what MSCEVs really are or what they do.
MAYASARI LIM: And we still don't have a thorough knowledge of the EV biogenesis. We also lack strong analytical tools to develop or define the CQAs for EVs. And we're still struggling to explain the mechanism of action. So there is still a long road ahead of those who are trying to create a sort of robust and effective MSCEV therapeutics, but we are noticing that there is more and more clinical trials using MSCEVs.
MAYASARI LIM: Especially even the recent ones that are targeting COVID. So we do expect this trend to continue in the next decade. [MUSIC PLAYING] One of the challenges that we see in developing allogeneic regen medicine lies in manufacturing scalability, and process no house to achieve through large scale economic production of a consistent allogeneic cell product.
MAYASARI LIM: And so when it comes to manufacturing living cells, there are inherent challenges in terms of ensuring that you maintain optimal viability and functionality of the cells throughout every step of your manufacturing process. And even though the biopharma industry has significantly benefited and succeeded in bioprocess technologies for monoclonal antibody production, which is performed in commercial scale suspension bioreactors, many of the region of medicine therapies primarily using MSCs are adhering base.
MAYASARI LIM: And so when we want to culture these cells in bioreactors, we have to attach them into surfaces such as microcarriers. So for us as experts in MSC base manufacturing, we really focus on developing upstream processes to support scalable manufacturing of MSCs. However, there is also the downstream technologies such as harvesting, separation, and concentrating the cells that need to scale alongside. And this remains a gap that we're facing.
MAYASARI LIM: And so in the case of cells, this is often the final products in cell therapy. The manufacturing process really becomes-- or is your product. So we often like to say that there are three key components that you need to know in regenerative medicine product and process development. And they are-- know your product, know your cost of goods, and know your manufacturing process.
MAYASARI LIM: So we recently launched a series of webinars that highlighted in detail the critical components of product and process development. And I think that early planning and understanding these critical components is really the key success in manufacturability of regenerative medicine products. [MUSIC PLAYING] So at RoosterBio, we really focus on meeting the needs and challenges of MSC therapeutic product developers as we-- or as they move from product development, to clinical testing, to finally, commercial manufacturing.
MAYASARI LIM: So our product portfolio encompasses human MSCs and media products that have the right quality grade and regulatory support that will ease the customer journey through their filing. At the same time, we're also developing sort of adjoining commercially viable processes and scalable systems to ensure their sustain success throughout their product lifecycle. So for our future product pipeline, which is still-- we still have a laser focus on human MSCs, we're taking sort of a multifaceted approach in designing products and services that we offer.
MAYASARI LIM: And we're looking at this from our customers' journey perspective. We ask ourselves, what are the tools and support that they need as they transition from our indeed great products to CGMP, and what products can we offer to help them achieve scalability? And then we also look at from a regulatory perspective where we're always looking at how can we increase our product safety profile to ensure end product consistency.
MAYASARI LIM: And we also look at, from a technology innovation perspective, what are some of the products that we can create to support emerging areas of MSC-based therapeutics, such as extracellular vesicles and genome editing fields? And finally, we also have a process development service offerings that are really still an integral part of our product portfolio. And this is something that we will continue to evolve in response to our customer needs.
MAYASARI LIM: And here, we are supporting customers to optimize and scale quickly their MSC, or EV upstream and downstream processes into CGMP manufacturing. So all in all, I'll say that we will continue to create products that solve our customer's biggest pinpoints. And RoosterBio continue to be at the forefront of high quality, hyperproductive product innovations that industrializes our customer's CGMP human MSC supply chain.
MAYASARI LIM: [MUSIC PLAYING] So there are many ways that synthetic biology or gene editing can improve advanced therapies. So first of all, synthetic biology is really sort of an iterative approach to design, build, and test standardize genetic components to create new and interchangeable biological parts, devices, or even systems.
MAYASARI LIM: So when you combine that with gene editing, then you can really accomplish two main task in advancing regenerative medicine therapies. First is that you're really making human cells as the cells [INAUDIBLE] for a variety of diverse, robust, but predictable platform application. And the second approach is that you could specifically engineer human cells with an optimized gene effector circuits to create targeted and controllable living medicines.
MAYASARI LIM: And in both cases, we would see them-- we would see the cells as sort of the hardware and the genetic code like a software application. So the possibilities there could be pretty wide or endless so to speak. And with that in mind, one of the ways that we can improve cellular therapy to meet diverse patient population, as an example, would be to reduce immunogenicity and prevent graft rejection.
MAYASARI LIM: And this could be accomplished by immunization, or tolerance induction. And we know that there is various groups who are quite active in this field of research, including those who are working in human pluripotent stem cells and immune cells. So there's also other approaches involving the placement of gene circuits to be switched on or off in vivo.
MAYASARI LIM: And we're really starting to witness some of these results from early trials of genome edited CAR T therapies, and other developments in hematopoietic stem cell-based therapies, and so forth. So while T-cell and immune cells are paving the way for advanced therapies, I think MSCs are definitely not that far behind. And one reason for that is that MSCs are very hardy cells that can be readily manufactured for safe allogeneic uses.
MAYASARI LIM: And they can also still be modified genetically with these tool sets that we have at similar efficiencies. So over the last few years, we're beginning to observe these genome engineering of MSCs to produce more potent therapeutics. For example, to secrete specific immunomodulatory cytokines or even grow factors to produce a localized sustained effect inside the body.
MAYASARI LIM: And these approaches can be applied to cancer therapy to create a robust anti-tumor immune response, or even suppress the tumor growth. Other groups are looking at modifying the EV cargo, or targeting modules using synthetic biology or gene editing. So these insights and learnings that we obtain from these early trials, I think, are going to be very pivotal for next generation gene edited cell base advanced therapies.
MAYASARI LIM: And along with the development of RoosterBio assets, and manufacturing capabilities, I think the opportunities for advanced regenerative of medicine products is going to be great. [MUSIC PLAYING] The availability of the application of MSC-based therapies is definitely going to continue to grow. So as we know there are already over 1,000 human MSC clinical trials registered to date.
MAYASARI LIM: And historically, there's more than 100 trials that are initiated every year since 2011. But this year, we're going to expect this number to go over 200. In fact, my colleague just shared with me this morning that the number is at 228 right now, which is phenomenal. So in the next few years, we are going to expect both the availability and application of MSC-based therapies to definitely increase.
MAYASARI LIM: And I think part of that reason is that we have a very strategic approach of standardizing and industrializing this human MSC supply chain for product development, which will help to ease and therefore accelerate the adoption of MSCs into cell therapy products, and future advance therapies. So by breaking down these barriers in MSC sourcing and manufacturing, we're really opening up the doors for more groups to readily incorporate MSCs into their therapeutic program.
MAYASARI LIM: So that's definitely a contribution that we're hoping to bring for the industry. And then we have emerging tools like CRISPR and machine learning that's rapidly progressing. So the possibilities for advanced and personalized MSC-based therapies could really be enlist. These early success and failures of MSC clinical trials is going to be very important in helping us to climb this steep learning curve.
MAYASARI LIM: And I think that the field will continue to evolve, but we will also get better at what we're doing. And we believe that a critical component in economic success of these future MSC-based therapies is going to be manufacturing scalability and control in the quality of the final product. [MUSIC PLAYING]