Advancing Bioprinting and Regenerative Medicine Solutions for Obstetric, Gynecologic, and Pediatric Applications

Quality Control and Scale Up trending idea

Description :

I'm submitting an idea to push more research and funding in the area of Quality Control and Scale Up for 3D Biomaterial and Bioprinting in especially Pediatric Applications but also in Obstetric and Gynecologic applications.  We need to better understand how well we can reproduce devices and tissue constructs, especially for low volume applications.  Scale up of both cells and materials for even low volume applications is still a major issue.  This is work that faces a hard time being published and even a harder time getting funded, but unless we can do this, we cannot translate devices for clinical use and implantation.

1. Where are we? What do you consider as the major accomplishment(s) of the use of bioprinted tissue constructs and/or regenerative medicine strategies the treatment of obstetric, gynecologic, and pediatric conditions?

I think that we can do in vitro applications well, and I myself have been involved in 3D printing of trachea devices that have been used in over 25 patients.  I view both as a significant advance. In addition, our ability to build patient specific models from patient image data and simulate complex physics of these models has been a major advance to aid device development.  However, we still face significant challenges in understanding quality control of 3D printed devices, and how such devices can accommodate growth for pediatric applications

2. Where are we going? What bold application of bioprinted tissue construct and/or regenerative medicine solutions would you like to see in the treatment of obstetric, gynecologic, and pediatric conditions?

Commercializing bioprinted and 3D printed constructs is a very difficult task.  Especially for pediatrics, but also for obstetrics and gynecology, I would like to see major academic centers establish 3D printed implantable device centers.  These could be networked to produce devices to treat clinical conditions that are not amenable to commercialized products, i.e. those complex clinical challenges with low market volume.  This network could share information on quality control and scale up for devices

3. Why are we not there yet? What are the major gaps and/or impediments (i.e., fundamental knowledge, technological, biological, regulatory, need for validated models/tools/biomarkers, clinical grade manufacturing, scale-up, financial, etc.) to the successful implementation of bioprinted tissue construct and/or regenerative

I believe a major reason we are not there yet is lack of funding and a condescending attitude from many in the research community who believe that quality control and manufacturing research is not "real" research.  This inhibits progress in this area.  Furthermore, we need to establish standards by which to compare design and 3D printing modalities with different materials and technologies, and better understand even basic knowledge about 3D printed biodegradation and regeneration in vivo - even understanding the basic temporal changes in biodegradable materials in the body, since many pediatric devices will need to be made from degradable materials.  Also basic understanding of tissue growth and mechanical properties is still needed to develop such devices

4. How do we get there? How could roadblocks be mitigated or eliminated to achieve successful implementation of bioprinted tissue construct and/or regenerative medicine-based therapeutics for obstetric, gynecologic, and pediatric conditions?

We need to value true translational research and what that means, especially interacting with the FDA and being able to fund work to get 3D printed tissue constructs and devices through FDA approval.  Study sections need to recognize that when you move through the regulatory approval path, this in and of itself is an innovation, even if you are using materials that have been used previously.  Study sections need to understand that "innovative" does not always equate to "new".  We need to really focus not only on the technology, but the model for moving 3D printed technology into translation and human use, which requires an understanding of regulatory science and clinical needs, and more understanding of the reproducibility in 3D printing and how printing conditions/parameters affect device performance

5. What will help us get there? What resources (e.g., tools, technology, human capital) are needed to advance the field?

We need more funding in this field and more development of GMP level 3D printing resources that could be shared by the general research and clinical community.  Maybe grand challenges to establish such printing consortiums with a requirement to enter into clinical trials would be a good U or P subject for funding.

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