We are thrilled to highlight our partnership with PulseSight Therapeutics, a pioneering ophthalmology biotech company dedicated to developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology. Their mission is to create life-changing solutions for patients suffering from severe retinal diseases leading to sight loss, with a focus on age-related macular degeneration (AMD), including wet AMD and late-stage dry AMD/geographic atrophy (GA).

PulseSight's proprietary non-viral gene therapy platform utilizes an electro-transfection system to deliver DNA plasmids encoding therapeutic proteins into the ciliary muscle, providing long-lasting gene expression and favorable distribution in the retina. This innovative approach has been validated in a Phase I clinical study, demonstrating a good safety profile and sustained clinical benefits.

Here’s what Thierry Bordet, CSO at PulseSight Therapeutics, has to say about working with INITS:

"INITS has been a crucial partner in advancing our CMC activities, providing exceptional expertise across process and analytical development, GMP manufacturing, quality support, and IMP management. Their comprehensive support in managing complex projects, from early-stage development to regulatory dossier preparation, has been instrumental in keeping us on track and meeting key milestones.

What sets INITS apart is their proactive approach. They not only help us overcome current challenges but also anticipate potential hurdles, offering tailored solutions that streamline both the technical and regulatory aspects of our projects. Their team’s ability to seamlessly integrate with our operations has been key to our success.

I highly recommend INITS to any company seeking reliable, expert consulting in CMC activities. They are true partners in every sense, and their technical knowledge, industry expertise, and commitment to quality have been critical in advancing our programs."

We are proud to stand alongside PulseSight Therapeutics as they advance their groundbreaking therapies toward clinical validation. Their commitment to addressing unmet medical needs aligns with our dedication to supporting transformative healthcare solutions.

Thank you, PulseSight Therapeutics, for your trust in INITS. We look forward to continuing our journey together, bringing innovative treatments to patients in need.

#Partnership #Biotechnology #Quality #CMC #GMP #IMP #Innovation #Biomanufacturing #Regulatory