WEBVTT

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One of our goals at bio fab USA is to

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be able to get these high impact

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products to market as quickly as

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possible . Part of how we do this is

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through our process development work

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and through a deep tissue

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characterization center , the goal of

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the process development group is to

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optimize our cell tissue and organ

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developers , processes and products so

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that they can achieve scalable ,

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consistent and cost effective

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manufacturing . Goal of the process

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development team is to take a process

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look at it in depth , figure out where

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it needs to be changed for

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manufacturing and then actually

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implement those changes . And so a lot

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of that is similar to traditional

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manufacturing where you want to be

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optimizing the amount of output for a

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certain input or you want to be

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minimizing cost or you know ,

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minimizing expenditure of resources .

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Um But you also have to consider here

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the kind of biological aspect of all of

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that . So how will cells respond these

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certain , you know , process changes

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because cells and tissues are very much

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alive . So , you know , it's kind of a

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balance of , you know , prioritizing

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these manufacturing concerns while also

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considering the underlying biology . So

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scientists have already made a lot of

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huge advancements in cell tissue and

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organ engineering . But they don't

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often consider manufacturing when

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they're developing their process . So

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there's a number of things that make

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the process of development and our

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tissue foundry approach unique . One of

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the most important things is that we

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think about the commercial

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manufacturing process that's going to

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be required as early as possible . It's

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likely that the commercial process and

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the early clinical manufacturing

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process look quite different . So we

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want to start thinking with a quality

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by design approach to manufacturing and

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process development . As early as

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possible process development really

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combines all of the elements of what

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we're trying to bring to at Army bio U

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A process development work begins with

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the tech transfer of the manual process

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to gain a deeper understanding of it .

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We conduct a detailed risk assessment

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and a gaps analysis to prioritize

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process simplification and improvements .

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Process development studies are

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conducted alongside any process changes

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or equipment development necessary to

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achieve the scalable modular automated

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enclosed version of the manufacturing

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process . Our vision is to enable new

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biomedical products by making them

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easier to manufacture . But we can

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achieve this with high density cell

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culture using cutting edge bioprocess

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and analytical technology to make the

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manufacturing of cells scalable ,

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consistent and cost effective . So some

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of the process optimization that we've

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been working on is to integrate in line

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sensing into these processes to have

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non destructive noninvasive real time

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metrics . And some of these examples of

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metrics that we have collected are real

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time complements and looking at

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different metabolites in our media to

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determine optimal media exchange rates .

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An important feature of our tissue

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foundry is using non destructive

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technologies to quality control . Our

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bioprocess . Our goal is to fully

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integrate this technology into our

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process to enable real time collection

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of information with these in line

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sensors . We are able to fully

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understand these processes and able to

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have consistency between runs which

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will help when we are scaling up these

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runs and going into clinical

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manufacturing , we make the process

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more cost effective and efficient by

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removing expensive media components and

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replacing them with easy to manufacture

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small molecules that do the same job in

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culture . We can also optimize the way

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we add those nutrients to maximize what

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the cells get out of the nutrients . We

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do add a lot of times you hear from the

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industry that these new therapeutics or

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cell therapies just aren't making it

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into patients . And seeing that biofire

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really focusing on manufacturing and

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regulatory standards and knowing that

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these products are likely gonna end up

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into a patient was really exciting for

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me and made me want to come join this

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team . I think more specifically , in

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terms of impacting people's lives , the

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products that are produced by bio fed

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USA have the huge potential to just

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increase people's lives . There are so

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many possible clinical needs that can

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be met by such a wide array of cell and

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tissue technologies that are out there

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already . And I think bringing those to

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market may change the way we look at

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disease and medical treatment in the

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United States .