<H4id="coll-heading"text="Collaborations as part of a integrated human practice - but why?"/>
<p>Collaboration is at the heart of innovative science, especially in projects with significant societal and clinical implications such as ours. By actively engaging with stakeholders across disciplines, we ensured that our work addressed real-world needs and took ethical and practical considerations into account.</p>
<p>For example, partnerships with patients and advocacy groups provided a deeper understanding of living with CF and shaped our patient-centered approach. Discussions with medical professionals highlighted the clinical challenges and regulatory requirements we needed to address. Collaborating with other iGEM teams allowed us to share methodologies, refine protocols, and integrate diverse expertise into our project.</p>
<p>These interactions didn't just guide the scientific direction of our work - they emphasised the wider impact of synthetic biology. By combining our technical efforts with stakeholder input, we ensured that our solutions were not only innovative, but also feasible, ethical and impactful. Collaboration thus became the foundation of a truly integrated human practice, bridging the gap between science, society and application.</p>
<p>In conclusion, the entrepreneurial journey of developing RNA-based gene therapy for Cystic Fibrosis, as outlined in our experiences and interviews with industry founders, demonstrates that entrepreneurship is not only an interesting possibility but a necessary avenue to transform scientific innovation into real-world solutions. Our approach has been shaped by the challenges and opportunities in the biotech field, from understanding regulatory frameworks like GxP to navigating complex market dynamics and funding challenges. </p>
<p>Through key interviews, such as the one with Nicole Friedlein, we have gained insights into the pivotal role of regulatory standards in scaling our project. The completion of GxP training by one team member reflects our commitment to ensuring compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP), both of which are essential for advancing from proof-of-concept to clinical trials. This foundation is crucial for building investor confidence and meeting regulatory requirements.</p>
<H4id="colls2024-heading"text="Home University of Linköping"/>
<p>The University of Linköping is one of the bigger universities located in Sweden. Since its inception in 1975, it has become a very innovative and highly renowned institution. </p>
<p>The project of Linköpings iGEM 2024 team: (description taken from their website)</p>
<p>“The product composition will depend on the enzyme missing or malfunctioning in each of the disease types. We’re going to target autosomal recessive congenital ichthyosis, as this is the one our friend is struggling with. We will focus on the consequences of mutations in three different genes (TGM1, ALOXE3, ALOX12B) that can underlie this condition [5]. However, if our approach turns out to be successful, after some adjustments, the protocol could be applied for the remaining types of the disease as well. First of all, we’ll engineer E. coli to produce the chosen enzymes encoded by the corresponding genes we chose: transglutaminase 1, Epidermis-type lipoxygenase 3, Arachidonate 12-lipoxygenase and then we will purify them from the bacteria. Once this system is established and optimized, we’ll proceed to design a functioning delivery system that we will encapsulate the enzymes in. We have decided to produce modulated liposomes that will be able to keep the enzymes active while transporting them. Once the target skin layer is reached, the liposomes will fuse with the membranes of the cells of interest, delivering the product to its final destination. Functioning liposomes packed with the produced enzymes will then be incorporated into a suitable medium to facilitate the topical application for the patients”. </p>