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WSCS 2015: How Advanced Blood & Tissue Banks Are Engendering Growth In Regenerative Medicine

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WSCS 2015: How Advanced Blood & Tissue Banks Are Engendering Growth In Regenerative Medicine

This Session Will Focus On Some Of The Ways Advanced Blood And Tissue Banks Are Helping In The Translation Of Biomedical Advances Into Clinically Useful Tools. From Access To Biological Materials To Manufacturing Capabilities To Regulatory Compliance Expertise, Specific Examples Will Be Given As To How Research Institutions And Commercial Organizations Are Benefitting From The Creative Solutions Blood And Tissue Banks Are Providing, And How The Blood And Tissue Banks Are Benefitting In Return.

Video Transcript


MODERATOR

► SEAN THOMPSON, MS, MBA, CLP, GENCURE




SPEAKERS
► C. GEOFFREY DAVIS, PHD, ANGIOCRINE BIOSCIENCE, INC.
► JED B. GORLIN, MD, INNOVATIVE BLOOD RESOURCES
► ROBERT J. TRESSLER, PHD, MS, SAN DIEGO BLOOD BANK



Gonna give review of some of the opportunities and also some of the issues that you consider as forward and smiling new approaches and Sean mentioned doing business the old way simply is not sustainable in the long term we have seen a steady and consistent decrease in immunization in revenues and sustainability of blood banks over the past several years and there's no obvious reason to believe that won't continue so modifying your business model at the blood bank to maintain sustainability we are after all da towards its gonna be key to our survival and also it's an exciting opportunity for all of us because stem cell research and regenerative medicine where the nexus right now where there's gonna be break thoughts in medicine in high demand in expectation from the community at large for better therapies but also an interesting them by bio pharma and developing them and we're at the cusp and then we are opportunistic place there's also a lot of pitfalls to consider though as i mentioned cell-based therapeutics are widely expanding our wine experience of development for regenerative medicine transplantation oncology immunology another indication indications inherent in that is the gmp manufacturer cell therapies and this requires cell sources that can be utilized for $3 cytokine sources and sell products generators and i'm speaking specifically tourists are personal experiences currently at the San Diego blood bank we actually are involved with a researchers and bio pharma entities doing these types of activities both get their research level as well as in clinical trial enablement the cell sources a key point they must be well characterized produced with rigorous manufacturing in cruise control guidelines the agency's always said potency and identity we need that even with peter layers are some impact there you have to be able to identify what you're doing cgmp qualifications accreditation such as scaliness or fact and FDA compliance must be met and blood banks are well positioned for these because we because of the product we generated over the decades have these oversights in place already is just just for cord tissue therapeutics this is just a graph showing that the explosion how from 2004 to 201212 there's been almost exponential increase in the numbers of clinical trials simply with hymeneal stem cell therapeutics the same thing is gonna hold is holding for c 34 cells and other major committed progenitors are being used as therapeutic approaches so it's a remarkable growth industry area an opportunity for all of us to be involved with one of my predictions is that right now cd 34 cells are great focus for us and a great need but mesenchymal stem cells are growing and made then surely become as a as important or maybe even overrun as soon as clinical trials prove that they work demand in terms of bio pharma or therapeutic standpoint he some of the potential products and services a blood bank could offer obviously he dmc'nonnuclear cells and red blood cells that could service peter lands or for cytokine production can be use net we've actually use some of these and we do just that for companies that are in clinical trials you also be participating in a same device development sometimes supplying cells to validate devices or to set up a city also obviously serum platelet and plasma components are growing area of interest the agencies and both eu and usa have been guiding us to get away from using fetal bovine serum it's difficult to get its easier to get human platelets in his to get fetal calf serum so becoming using platelet stately products or platelet derived products as an alternate media supplement to grow your human cells that you were not used to treat patients within the clinic is favorite approach right now ultimately purely government totally defined media that serum-free and has no animal components is where we like to get but right now there's still deficit in terms of those defined media always working and it looks like things like platelet stately products or show great promise and their number of companies actively pursuing this area obviously cord blood and tissue cells for transplantation is committed progenitors and cell based therapies have all heard of car t cells were now there's car ok cells you might be able to use this as a source material he says maybe a bit more difficult but in case sales there's been a number of of robust papers now showing you can barely make cells and ok progenitors from cord blood progenitors so there may be an opportunity there as well mesenchymal stem cells in it's on everybody's lips right now at all the meetings i go to and clearly it has great promise but is also you know picking the right type of mesenchymal stem cells going to be important to alot of the trials right now are telling us we take a person with an autoimmune disorder and inherent in that is the inference that the mesenchymal stem cell milieu that patient is somewhat smaller they're taking those msc out of that same patient making more than putting bank in with the expectation that more is always better maybe it will be here maybe we need to do a better job at once again potency and identity identifying the right cells that we use cord blood banks and blood banks in general have an opportunity to actively engage in that by supplying healthy donor hymeneal stem cells for characterization setting benchmarks and the new and growing areas the precision medicine aspect of this bioinformatics blood banks are uniquely positioned to longitudinally evaluate tens of thousands of normal healthy donors over their lifespan we have done is that have been coming into the same ago but thanks for twenty to thirty years hundred gallon donors and every time they come in we get a sample of blood if we can now put in place irb clearances and consents to allow their blood their genome to be analyzed overtime and trekhow person goes from being healthy unhealthy and what gene signature shift especially now that you can power with this large number of people you may have a much more precise way of defining those genetic elements or enticements that are key to disease are key to better treatments he points to consider when you excess blood bank so check the resources and research and make sure we've got the bandwidth to help you out if your bio pharma that's looking to work with us make sure they have a robust quality and regularly oversight team we certainly dodo telling Dixon is my best friend in the world she was until i moved here a year ago but she's my vice president of regulatory affairs and keeps us out of the weeds and keeps us on track source material we do things i don't recruitment consent irb clearances interesting and tracking and other types of entities on behalf of our customers because we do that anyway for the patients we serve some of the advantages are blood bank said well established cgmp compliance accreditation quality and regularly oversight for sell products being produced we have a large recruitment in Ghana base for collection of source material and leave now mature din terms of are consenting strategy to make sure we're sure that we have all the clearances from Nairobi standpoint and from a consensus standpoint for used for research purposes you have to be very careful there a lot of people at night he said well if you consent to research it's ok you can use it for anything but now it's it's a bit more selling that you have privacy right you have to dress commercialization rights you have to dress make sure you're very transparent to the donor about this and we've done that we've we've gone to great lengths to make sure no one is not aware of what's going to happen with the material if they agree to a lot be used for research purposes you also have established infrastructure and trained qualified personnel for production products we go to repeat it periodically training and competency across the spectrum of all the activities you do it blood banks so it's it's a it's powerful opportunity for bio pharma and others to work with us we're already trained already qualified we already have the oversights from a safety standpoint that we need to generate products for people to use we can serves a single site for consent processing testing sterility and radiation isolation enrichment and process storage and distribution so we can be a one-stop shop for a lot of this is well in conclusion we are well positioned to collaborate with industry and academics in the realm of cell therapies complex laudatory and predatory shoes can be management but thanks we do that on daily basis anyway but we've been through 45 audits in the past eight months and successfully so part of that is when you the customer is what is known as a cgmp audit customer product to make sure yourself compliant for their product they want to make sure we have a new era stem cell-based medicine its rapidly growing focus diligence quality assurance and regulatory guidance consent are all key to generating products that can be used to help to make this world a better place thank you rob deftly handled the idea of opening up this notion of of how what what services groups like us can can offer and in a bank in back last year i don't know if anybody was here last year we had a session on on how advanced blood banks can help bridge the gap you know the kind of the valleys of death that we've all heard about between a a scientific advance in a medical breakthrough so last year it was all about what we can do this year with what we hope to do is talk about what we are doing okay and and show some some things that they rob was talking about providing feeder layers and things like that those are things that they're already doing they just cant talk about i am going to talk About a little more more things about what we're actually doing because we've gotten approval to to do so so first of all so who is by abridge global so by average global is a the parent organization of for 501 three so where it's a five 501 c three nonprofit holding company and for a 501c three functioning subsidiaries and the emphasis there is is on functioning and operating subsidiaries so really the first three qua latex Celtics blood tissue and and jen cure or the operating subsidiaries the fourth is is foundation so-called tax is the largest independent not-for-profitin tissue safety testing laboratory in the united states we test on average about somewhere around the eight million samples market probably about 40,000samples a day you know in a vial of blood is is is a sample so forty thousand a day it's an interesting on an industrial scale and so we're moving in you know i think crime trying to think of you know what else can we test all right so cell and and cell-based therapeutics are are an area that we'reconsidering as well so that's one thing i'm not gonna really touched on that much south taxes blood and tissue center that's the the blood bank and once again industrial industrial scale blood bank with your network partners we have no place little i say you know we sell outdated platelets and just just as everyone else does but and then jen cure that's are not for profit a blood and tissue safety really regenerative medicine group and i'll go into more detail so company statistics 750 + employees that sold we have locations both in in taxes San Antonio and nor cross just north of heartland so go figure last year the world Santos was in san Antonio here to atlantic go figure it's great so projected revenues about 230 million in 2018 so we're a not for profit ok but a pretty darn big not for profit ok so and we live and breathe in the not for profit world you know people talk about you know blood banks you know you're not for profit you don't understand ok it's it's it's it's a excuse the pun it's a blood sport you know it's a blood blood bath i mean you've got there's a great deal of price competition in in this area so get that whole not for profit they just everything comes easily to them out of your mind so we we really do live in the in the for-profiting in the real operations were let me put it that way the biggest growth opportunity that we've seen is is in the area of regenerative medicine cell-based therapeutics and products and these are offerings for which jen cure and i'm the again the the interim chief operating officer gen cure we will play i think is a leading role so who is jen cure has i said we have we are the regenerative medicine spoke associate we have three groups one is the Jim Kerr tissue center then there's a drink your cord blood center and junior senator therapy center so the ginger tea she salmon kind of speeding through these we're essentially jen cure is an or tho biologic company right now that's primarily we're where we get most of most of our our our there put if you will but we provide human tissue allograft implants for hospitals and clinics for use in orthopaedic replacements received procedures spare parts you blow out an acl you kind of need a new one right so we're good friend we're the only drink utc centers the only full-service tissue bank in texas by full-service that means that we can recover we can process or manufacture and distribute so we're vertically integrated that way we are retried really tried to think hard about you know those sorts of things again the only one in taxes and texas is a big state eighty bin and is approved we have the gin cure cord blood center jointly funded by to the taxes legislature so people talk about she does it take an act of congress to work with you guys withhold know but it did take an act of congress to set us up so again where the official cord blood bank of the state of taxes we obviously collecting process umbilical cord and related tissues for clinical use and we'll get into that in a little bit and research partner with firms biotechnology organizations looking about you know how these thing scan be used and so and then lastly the gin cure cellular therapy center will be the match the national marrow donor program which you guys are all familiar with Colette we collect peripheral blood stem cells for him transplants we are unusual in that we have about 80 per you know 80 85%minorities so where are fairly in in demand not only on the pbsc side but also on the corporate side as well and we participate in one fda-approved therapy and for clinical research studies right now so we're doing both you know clinical actually clinical use clinical research and basic research all in one shot so so what do we want to do right by a bridge global this is an actual had four cups from the world stem cell summit a couple of years ago our goal is to help enable regenerative medicine that's really what we want to do and we're already doing it this is this is somewhat old so let me show you what we're already doing alright so this was a press release that went out a couple of days ago where stem by assists and and by Irish global are in collaboration to provide human umbilical cord blood cells for research use and notice i said cord blood cells what we want to do is you know if you're offering something that everybody else does we are to do that and i'm a blood side right blood blood blood what we wanted to do was offer offer a type of stromal cells stem cell that's unusual alright so anybody will tell you that the number of truman's a camel stromal cells in umbilical cord blood is very very small alright well this this company symbiosis has come up with a way to isolate many more umbilical cord blood stromal cells using their product called their hp amer high-performance micro-environment basically they the the brilliance of this is they didn't try to help think nature ok so what bone what what you know the bone marrow niche in your in your bones they build their own house they they they make their own structure they build their own house and so doctor shower change who founded the company but let's not write it out think it alright so he took out a bill called bone marrow aspirate you you put it on you played it and and caused the bone marrow stromal cells to lay down a matrix of an extracellular matrix basically build a house remove the cells and then you have a a substrate then that is perfect for keeping cells in their keeping their their their phenotype alright so they offer this as you see at the bottom as a research research product and we have we had opened our doors to them some couple of years ago to build out to remember we're not for profit but we invited them in because we're we're really trying to get closer to the biotechnology world and and so they are literally under our roof they have their own little sovereign territory and that's where they make this gmp grade material for expanding cells so pretty good stuff but beyond that remember so we have the Texas cord blood bank we have access to lots and lots and lots of umbilical cord blood and so what we decided to do was take these cells that stained by us is isolated expand them you know actually pull out the colonies expand upon rhp me to a to the level to the number that then we can take and then put into the terumo bct quantum cell expansion system and and and i see my my colleagues from from terumo bct over there and thank you very much for coming so it made a great deal of sense to to meet us at the time because remember except for maybe adipose-derived mesenchymal maelstrom cells any cell that's gonna be used any msg that's gonna be used will have to be expanded some some point in some form or fashion ok because they just don't exist in that mean numbers until you unless you unless or until you expand them to be used clinically ok so what occurred to me will geez let's let's go with a system let's build our our kind of our real options bets in these areas where that are set for for scalability alright so the notion here was let's take these umbilical cord blood cells that exists in very small numbers expand them on their hp me keep their phenotype sticking in this machine expand them in great numbers and then offer them as are search use only product for that is quite rare and so that was the idea here and and we expect that our friends from symbiosis will be will be selling these early in the July some somewhere in the new lifetime bring something like that so very excited about that and then next so something that we're already doing or have been doing is working with the company x biotech out of Austin they have come up with a thing that they call the true human antibody discovery process will basically they take b cells from our donors scan them for a certain type of antibody that they're looking for once they find them we call me again get their lives cells they go into their genome get the genes responsible for for making that antibody and then it's a true human everybody talks about humanized it's really cool lows murine and human know this is true human it really really human all too human antibodies and there are in clinical trials right now for mrsa and i will an antibody against i'll 6 both of those came from donors that we provided to them and they're doing quite well and i'm very excited and you'll notice there this picture of the bottom you noticed ebola writing right now able as you know i'm passe but remember about this time last year but it was quite freaked out about about a bullet well partly because this person amber Benson nurse at taxes Presbyterian hospital got ebola well we brought her in as a donor And you know by definition if you've survived ebola you're making the antibodies alright so we pulled out her her her bled gave it to x biotech and there will be going into clinical trials for an end and type Ebola therapeutically gen Pur initiatives i'm just about done we just made and this is not new to the world but new to us a proprietary decriminalized bone matrix product remember where north of biologic company so we're we're coming we're not for profit but we we're moving in the area of providing these batted value-added services on the materials that we already provide and we will soon offer therapeutic a pheresis services to a large local hospital i just can't talk about which but it's a large local hospital so again what we do and that's a picture of Vanessa working with a patient to pull out her peripheral blood stem cells that's what we do very well so let's rely on what we already do very well and offer these additional value-added services to others and thine think finally we are we are sourcing and me on tissue for care companies right now and that's a picture of one of our texts holding up when i called group in a bag so that that is a placenta in a bag an excuse me that's one of the one of the first photo be careful what you let me take a picture of because it'll often end up on slide but it looks much much better than that that we will soon in addition to just offering group in a bag to see these these these products companies we will soon manufacture our own handgun based on cover product based on the products that we already have and the idea here is look we're not trying to take over the world it's all about being sustainable ok what we intend to do is take these products that either never we never bring in the door or that we bring in the door and end up his medical waste take that take those products add value and then take those resources and play them back into the organization so that we can do do more good right you know do well by doing good that's the plan alright so meet next up is is Jeff Davis who's going to talk about his his things with and Ukraine ok thank you Sean for inviting me to participate we are a small biotech company working in the field of regenerative medicine and when we are part of this group here not because we committed to working with the blood centers but because we are working on a program that clearly is very relevant to the blood centers and we obviously understand the need to work with the blood centers and understand what they have to offer we've been having a lot of conversations and understand their capabilities has been elusive at least a by rob very nicely already really understand we need to work with them but still trying to figure out just how about the same token we believe that we have a program is going to really contribute to the blood centers as well so it's going to be a symbiotic relationship ultimately once we figure it out so we are the echo company we are committed to regenerative medicine i'm going to tell you about one program today which is a program in cord blood stem cell expansion companies based on science laboratory of dr. Shahin Rocky well Cornell medical center and she's research has been base don the understanding that endothelial cells or something more than just conduits and in fact that they really provide an executive function to stem cells and more or less ted tells themselves what to do and they do this through so surface molecules as well as reducing created factors factors that she needed ugh engine crimes ensuring that now is very common in the lexiconin order to really translate the scientific was n't information into something that has potential for therapy she made really serendipitous discovery dad he could introduce a single gene this is the gene called adeno viruses if war or one intended a little souls in this wind down and ethereal cells with the ability to proliferate age are quite indefinitely they're not immortalize but to undergo many serial passages so you could expand these cells into numbers relevant or therapy and importantly it also houses cells with the ability to be expanded in the absence of serum so we talked earlier about the importance of getting away from serum with these cells in fact you can get away from serum they willgrow in serum-free media and what's nice about that is that enables the proliferation of stem cells that retain their stem this and culture so we cause these cells to expand stem cells to retain their stem like property because we're not introducing serum that commission exaction factors that can send stem cells every which way we've recently succeeded in actually maybe in the system out of the flash and into a closed system i can tell you to name it just embrace because we have an upcoming press release but those of you that good short-term memories can probably figure that out so we've been able to use this system working with gerhard power at uc davis to use the system and gmp mood to expand the endothelial cells and cells but as you'll see also to expand additional products says it's a totally automated system a closed system unimportant and gives us a lot of options when we think about downstream manufacturing so using his system we're actually thinking about three different kinds of programs has three different kinds of programs well advanced so bright side you'll see really serve our lead program switches using the endothelial cells themselves as the therapeutic and we have a number of publications indicating that these individual cells will foster organ regeneration in a tissue-specific manner that the west side is the one that will be really focused on today which is using the endothermic cells to expand stem cells for diabetics stem cell transplant so why we want to expand stem cells from cord blood and sand sure many of you are aware cord blood does offer a lot of advantages compared to the other sources of stem cell transplant cord blood cells are inherently more plastic and so is a lower incidence of gvhd others lower rates in relapse corvette is readily available with 600,000 units stores around the world and so is enough diversity out there to really be able to serve every patient who needs a transplant but there are also a number of drawbacks to cord blood and those drawbacks include slower rates of engraftment higher rating failure but these drawbacks all stems back to one single issue and that is just your typical cord does not have enough stem cells and ordered to reconstitute an adult in seven solution really scenes they obviously not the only people who realize the need for this and that is to be able to expand the cord blood stem cells so their number of other companies and and academics working on this we think our approaches a little bit different now we're using a cell based approach we think that expanding these cord blood stem cells is a complex problem requires a complex mix of factors but these factors can all be supplied by the same cells to supply its factories in vivo which our agenda see also so it's like shows the typical pattern to differentiation of stem cells are really what you're trying to accomplish when you expand stem cells ex vino is to keep them in their stem like state so when they go into the body then they can undergo differentiation and again using our system in disclosed device we can use the technology in the absence of serum to expand the stem cells that keep their stem is so that when they go into the body they can fully reconstitute all the different lineages we've made his first observations sexy prior to the formation of the company and in redactor Jason butler who is working she not these lab at the time and 2012 publication and website shows is using thing the technology you can expand very premise stem cells that will populate skin rise both in primary and secondary fashion as a serial transplant go still repopulate succeeding generations of mice indicating that these really are so sorry train retain their truce tennis so based on those we're looking at a product they had just going to be derived from co-culture the EC cells in these cells derived from umbilical cord and he sells with a match cord blood unit will rapidly expand these and we can expand them and they claim 20 min time span 6 to 10 days and expand 6200 sold over a period of time the stem cells and expanding cord blood cells with Wendy Cohen fused together as a single therapeutic product and we believe that the end is still in cells are n't playing role in facilitating grasslands of the stem cells so in bio product manufacturing we're not quite resolved on how we gonna do see ave using the closed system we had the opportunity of a city expanding themselves at the point of care or at select regional facilities and caused a month so select regional facilities the cord blood banks with all their expertise and experience in regulatory and quality issues certainly comes to mind is for friends we now have positive pre-clinical proof of concept sense that 2012 publication so it does a lot of work now not only mice but also non-human primates with two academic investigators who once ran into sealed of studying stem cell differentiation in primates they use their technology expands them selves their bar-coded and then able to determine the exact these expanded stem cells will repopulate all the different lineages short-term and long-term and we now monkeys out there are over two years reconstituted with stem cells expanded from our technology so we feel that this program ultimately successful is going to provide value across the for those killer spectrum obviously is going to provide value to patient's in allowing safer grass with a lower incidence of gvhd race-based short and long-term engagement shoot with the Short-term investment should get them at the hospital quicker and reduced the transplant related mortality associated with how the longer delayed engraftment associate with cord blood transplant but also focus on the website for the quarter bank we're really giving equipment banks better opportunities provide a match allows them to make better use of all the units that they harvest won't beadle to greatly reduce that's rational acceptability based on the tnc can and hopefully really open up the cord blood business and allow all those units are currently sitting in a bank that are not useful to be useful and the wildest dreams is this really works i think it opens up the door or or stem cell transplant as a reasonable up-front procedure outside of the blood cancers words so prevalent now and live that close and best baton to the next speaker so welcome to memorial blood centers which merged with the blood center in Lincoln Nebraska if you merge go through with the huskers you better be innovative hence the name innovative blood resources we do a lot of stuff we are more fun than the average blood center we recruit donors process exactly all the stuff you've heard by my colleagues and we collect and process and other portable generators from patients and the national marrow donor center one of the testing centers for the national marrow donor center we actually are the the home of the national marrow donor center in Minneapolis and so i am on their human subjects committee our head of marketing was over talking to the Minnesota twins and looking out the window and say no what's that construction across from the twins stadium all i think it's a dating company the head of communications between said why is that let says be the match said before you come up with an innovative media companymake sure they know what it is just saying how we be testing for like sales of qualatex donors national marrow donor program fertility clinics we test drovea hundred and thirty-three chili contest with the iowa mothers milk bank which was a fascinating place to visit and are wonderful group every day many clinical trials which involves donor screening collection collection various products as you've heard from from my colleagues but also providing a lot of products and components for trials we are sort of the source of medical all is a lot of medical device companies to medtronic Boston scientific before they will he said machine that processes blood yes they let a lot of cow blood through it but they also often need to do human blood at the american association of blood banks with this wonderful cleaning company now no end tech that it is amazing electrical engineers have kept showing the product each year i said well you know when are we going to be able to use this to count the residual two sites when we take the white cells out of blood and so we did not one not two but three clinical trials with some and finally i made them sit down with my FDA advisers sure who's ten years of experience at the FDA as you heard this morning from the FDA officials sit down with the FDA first before you do the clinical trials said that you provide the number data they need anyway we we did that and so this is a cute little device that is much cheaper quicker than doing lessons activated cell sorter and so i said ok what about c 34 so we are now working with them and they are developing this machine to counsel e34 cells which can be very convenient for those of us who don't want to have to use facts for every scene he's only for account i did want to since since my colleagues have done such a wonderful description of all them using it grew these things that blood centers can do to do a little deeper dive and so my friend all deed started male was kind enough to share some slides with me so i'm from their development on mill creek which is basically making played live mice at like the san diego blood center on answer you've heard a lot about mesenchymal stem cells and all this stuff they need so i'm sort of simplistic and basically arm then growth factors are pretty simple salt sugar and some some some vitamins and minerals that the challenge for me is protein and as he heard from from dr trust let you know calf serum with mad cow disease probably is not the ideal source of stuff so why not use stuff that is incredibly well screened incredibly well controlled and collecting the gmp environment play let so you can see this is just some some basic science data from that shown that 5% played the lysate makes them grow faster than 2% and 1% etcet era but it's also incredibly consistent because these report products and so you can see the doubling number per day were measured in new number of doubling time dublin's overtime is incredibly consistent lot to lot and i think it's really important for manufacturing standpoint you don't want one supplier you wanna have multiple suppliers out there so it's good to have you know places like San Diego and mail and others developing these products because you know god forbid the tornado hits you want to have validated multiple sources and maybe you no one has a better applications and going one kind of cells versus another and it's worth it's worth being that basic science i'm so they actually had multiple phase 3trials undergoing they're they're supply inginternationally and so this is a byproduct and you know we get and the better we get it not out dating platelets less that supply goes down and so it is important to have multiple suppliers and so what does one expect ofa supplier all of these things to you heard i think of talking about from the FDA speaker this morning who better to do that than those of us that have been being glared at by the FDA panel has two decades we are certainly well consistent with that so it's hardly are only our own blood center Oklahoma and mayor also contributing to the payload max product and so are the recognition of the time i will integrate their thank you i said the tests and other opportunities and knowledge just three days ago china has just released and regulation on the stem cell clinical research and the many step change in your soul and video conference 40 if it's any opportunity they still put up the company's i'm looking for expansion in china and would like to be present as dad animation do medical multi center clinical trials on this but also will now have a parade bank 40 percent public bank and bank and they have been going to have around 8,000 to 10,000 harpsichordist so we seem to bea lot of missiles on then move on to explore collaborations clearly clearly i the numbers are quite staggering that i have heard of it in china so i think you'll you're in the right place certainly true that if there's any thoughts about that among the panelists for a comment and a question so i have had the honor of many cities in china and i have been really impressed at the progress in the most general blood banking as well as the donor screening there and literally did visits three years apart when there's basically no nucleic acid screening to now widespread nucleic acid streaming soit's been amazing lead to progress in general blood banking my son sure that's spreading the cord blood banking as well with these new regulations cord blood expansion friend anti-crime certainly realizes the potential to market in china and that is front and center for us we had started having conversations already know agreements inked but you can certainly count on us paying attention they're very expensive to maintain in and have on-site so with all of the experience of blood centers have working never using clearing them being able to provide sell products to patients where you see kind of your manufacturing process sitting in in an insane or more outside of 1000 ad deal with that in fact that was one of the one of the thoughts that we had as to becoming more relevant to the rest of the world and clearly that's an area that we we excel at is expanding these these cells in a gmp environment and so many of the biotechnology companies don't have the resources it's extremely expensive as you indicated with the with a cleaner environment too investors have dubbed don't have a sense of humor at all about spending their their resources on bricks and mortar in building up facilities will we already have it and so i think the future is blood and tissue centers particularly the more advanced blood and tissue centers offering there's their sites as as essentially contract manufacturing organizations for these companies where they can expand these cells so there's that address your issue or question we can all absolutely we can absolutely oh yes well and hopefully hopefully there will be these these clothes systems yet these clothes systems where where it may not be necessary like these these closed expansion systems any thoughts yes i this is rob hiding around the corner from you we have we have a hybrid system we have both ISO certification clean rooms as well as non ISO certified processing rooms and a lot of it's driven by is the process we're using a closed system if it's a closed system you're not mandated to be in ISO clean room we have other systems that are are hybrids recall i'm semi closed which is a euphemism for their own pen ok hello regulatory thorax we get it and we do those in a clean room we we obviously right up front when you're working with a potential customer collaborator you want to find out what their processes and then and that's part of what i alluded to know the resources know the capability in the bandwidth of the blood bank you're working with do they have the ability to work either way because get staying out of the clean room is a cost of goods effect for you guys staying in a clean room is a safety assurance Effect from 949 closed system so you want to have both and dependingon depending on that the manufacturing process or whatever system you're working withi believe we are out of time to time yes yes yesokay thank you all for your attention and it just so happens to be put in ajust a plug for byron's global and jim kerr we are looking for a seniorscientist so if you happen to know of a phd a cell biologist molecular biologistdevelopmental biologist who happens to have experience in these are thebiologics bundes kind of stuff lemme know we need to see we need to build alab so thank you very much.

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