<p>We employed a structured feedback cycle based on Gibbs' Reflection Cycle, ensuring our design continuously evolved with stakeholder input. From initial design to public outreach, every phase of PreCyse was shaped by the feedback we received, allowing us to develop a patient-centered and globally relevant solution. </p>
<H5text="Documentation and Future Guidance "/>
<p>We are committed to transparency and open science. Our detailed documentation of stakeholder interactions and methods—including protocols for working with human nasal epithelial cells[Link]—provides a foundation for future iGEM teams. Our outreach efforts, including educational materials and public engagement campaigns, help foster a broader understanding of CF and gene therapy, reflecting iGEM’s vision of responsible and impactful scientific practices. </p>
<p>We are committed to transparency and open science. Our detailed documentation of stakeholder interactions and methods—including protocols for working with human nasal epithelial cells[Link]—provides a foundation for future iGEM teams. Our outreach efforts, including educational materials and public engagement campaigns, help foster a broader understanding of CF and gene therapy, reflecting iGEM’s vision of responsible and impactful scientific practices. </p>
<H4text="Next Steps"/>
<ol>
...
...
@@ -414,7 +414,7 @@ function AnalyseBerens(){
<Collapsibletitle="Dr. Eva-Maria Berens – Head of ethics committee at University of Bielefeld"id="berensanalyseC">
<p>In our pursuit of generating primary cultures from human nasal epithelial cells for testing, we sought advice from the Biosafety and Security Committee of iGEM, as well as consult with Dr. Eva-Maria Berens, our ethics officer. Through in-depth discussions with Dr. Berens, we carefully assessed the risks and legal obligations associated with our project. We learned that, given the minimal invasiveness of the procedure, no formal bioethics application was necessary. However, we recognized the importance of developing a legally sound informed consent form for participants, ensuring that we adhered to the relevant legal frameworks. </p>
<p>In collaboration with various legal institutions, we drafted a comprehensive informed consent form that complies with both national regulations in Germany and the specific policies of Bielefeld University. As the first iGEM team to tackle the complex cultivation of human primary nasal epithelial cells, we were committed to paving the way for future teams. To support this, we created a guideline documenting the proper handling of human biomaterial obtained through these types of sample collection. </p>
<p>Additionally, we worked with Mr. Timm Weber[Link], who is working for the local biobank OWL, to establish protocols for the management and storage of sensitive, personally identifiable data. While no special procedures were required for our specific project, we nonetheless made it a priority to implement anonymized methods to protect participant privacy. </p>
<p>Additionally, we worked with Mr. <aonClick={()=>goToPagesAndOpenTab('timm','/human-practices')}>Timm Weber</a>, who is working for the local biobank OWL, to establish protocols for the management and storage of sensitive, personally identifiable data. While no special procedures were required for our specific project, we nonetheless made it a priority to implement anonymized methods to protect participant privacy. </p>
<p>The input and feedback from Dr. Berens and Mr. Weber formed the basis of our ethical consideration of our project. With their help, we were able to improve our technology on primary cultures with a higher level of safety and an adapted guidline. In addition, our biosafety contributions were significantly improved as we were able to ensure compliance with all legal and ethical standards.. </p>
<p>Having established the necessary ethical and legal groundwork, we turned our focus to the practical aspects of handling and cultivating patient samples. This required specialized expertise, which led us to seek assistance from <aonClick={()=>goToPagesAndOpenTab('michaela','/human-practices')}>Stemcell Technologies</a> ensure the successful cultivation and maintenance of the nasal epithelial cells. Their support was essential in enabling us to push forward with our testing and bring our project closer to real-world applications. </p>
<p>Dr. Kolonko's expertise in nanoparticle stability was invaluable in refining our delivery system. Her recommendation to utilize chitosan for greater stability influenced our formulation choice and we further investigated how to integrate chitosan in our LNP[Link HP Mooralch]. Additionally, her insights on cytotoxicity testing, particularly the MTT assay, and medium conditions such as using OptiMEM for transfection, greatly improved our experimental design. We explored the potential and importance of chitosan in lipid nanoparticles, learned various techniques for characterizing LNPs, and implemented effective cultivation techniques and tips for cell culture, with a focus on contamination risks and the use of OptiMEM medium. Overall, Dr. Kolonko’s guidance has been instrumental in shaping the safety and efficacy of our project. </p>
<p>Dr. Kolonko's expertise in nanoparticle stability was invaluable in refining our delivery system. Her recommendation to utilize chitosan for greater stability influenced our formulation choice and we further investigated how to integrate <aonClick={()=>goToPagesAndOpenTab('moorlach','/human practices')}> chitosan in our LNP </a>. Additionally, her insights on cytotoxicity testing, particularly the MTT assay, and medium conditions such as using OptiMEM for transfection, greatly improved our experimental design. We explored the potential and importance of chitosan in lipid nanoparticles, learned various techniques for characterizing LNPs, and implemented effective cultivation techniques and tips for cell culture, with a focus on contamination risks and the use of OptiMEM medium. Overall, Dr. Kolonko’s guidance has been instrumental in shaping the safety and efficacy of our project. </p>
<figure>
<divclassName="row">
<divclassName="col">
...
...
@@ -555,12 +556,13 @@ function AnalyseKolonko(){
)
}
functionAnalyseRnhale(){
const{goToPageAndScroll}=useNavigation();
return(
<Collapsibletitle="Dr. Benjamin Winkeljann – RNhale, Industry Expert & Researcher "id="rnhaleanalyseC">
<p>Dr. Benjamin Winkeljann from <ahref="https://rnhale.com/">Rnhale</a> provided crucial technical guidance that significantly enhanced our project. His expertise in spray-dried lipid nanoparticles (LNPs) allowed us to improve the shelf-life and scalability of our formulations. We learned about the limitations of CF therapies regarding international access, cost, and availability, which highlighted the need for sustainable solutions. </p>
<p>We discovered that spray drying is an effective method for stabilizing LNPs, enabling transport without refrigeration — a more environmentally friendly approach that reduces energy consumption. </p>
<p>Our close collaboration with RNhale will continue even after the wiki freeze, focusing on producing spray-dried LNPs and testing them on our primary cultures. We are also investigating how to enhance the stability of LNPs, particularly in protecting RNA from heat damage, and are seeking experts in chitosan for further support. </p>
<p>During discussions with a young startup entrepreneur, we explored the possibility of pursuing an entrepreneurship-oriented[Link] project but ultimately decided to focus on a human-centered approach that prioritizes the needs of CF patients over cost-driven industrial pathways. </p>
<p>During discussions with a young startup entrepreneur, we explored the possibility of pursuing an <aonClick={()=>goToPageAndScroll ('Further Engagement3H','/human-practice')}>entrepeneuship-oriented</a> project but ultimately decided to focus on a human-centered approach that prioritizes the needs of CF patients over cost-driven industrial pathways. </p>
