<H5text="Role of GXP in Scaling and Proof-of-Concept"/>
<p>To take our RNA-based gene therapy for cystic fibrosis closer to clinical trials and potential market entry, investors and regulatory authorities need
confidence in the quality and reliability of our work. While the current iGEM proof-of-concept demonstrates feasibility, investors typically expect a
more sophisticated validation, especially in <b>In-Vivo models</b>. GXP would be fundamental in achieving this next step: </p>
<ul>
<li><b>Good Laboratory Practice (GLP)</b> would guide the experimental setup in animal models, ensuring that the results we generate are reproducible and meet regulatory standards for data integrity and safety. This is critical for progressing to preclinical trials. </li>
<li><b>Good Manufacturing Practice (GMP) </b> would play a key role as we look to scale our production. Not only would we need to produce our RNA constructs consistently, but we would also have to demonstrate that our manufacturing process can be scaled while maintaining quality and safety, which is essential for attracting investment. </li>
</ul>
<H5text="Insights from GXP Training"/>
<p>One of our team members recently completed an intensive GXP course, which reinforced the importance of standard operating procedures (SOPs) and rigorous documentation throughout the development process(HP_GXP course). This training has prepared us to implement practices such as Failure Mode and Effects Analysis (FMEA), a risk assessment technique that will help identify potential issues early in the development phase, ensuring we can preemptively mitigate risks. </p>
<p>As we aim to move towards clinical trials, GXP ensures that our product development pipeline is both ethical and compliant with international safety standards, which will be key in discussions with investors and regulatory bodies. By embedding these principles early, we not only enhance the quality and reliability of our data but also lay a foundation for future clinical applications. </p>
<H5text="Next Steps"/>
<p>As we move forward, our team plans to gradually integrate GXP standards into our development pipeline. The knowledge gained from the GXP course, along with expert consultations, provides us with a better understanding of the regulatory expectations in the biotechnology field. While we are still in the early stages of applying these standards, we aim to align our processes with industry requirements. This will ensure that, as we progress, we maintain a high level of quality and compliance, particularly as we scale up production and move closer to potential clinical applications. </p>
