We’re excited to highlight our valued partnership with Coave Therapeutics, a clinical-stage biotechnology company headquartered in Paris, France. Coave Therapeutics is dedicated to developing innovative gene therapies targeting rare ocular and central nervous system (CNS) diseases. Their proprietary ALIGATER™ platform (Advanced Vectors-Ligand Conjugates)  introduce chemical modifications to AAV capsids or Lipid Nanoparticles (LNPs), effectively overcoming the limitations of current vectors in terms of efficacy, safety, and manufacturability.

At INITS, we share Coave Therapeutics’ passion for advancing the boundaries of biopharma. Over the past few years, we’ve had the privilege of supporting their development programs and collaborating on critical aspects of CMC strategy, regulatory affairs, and GMP compliance.

Here’s what Nicole Brument, VP CMC & Supply Chain at Coave Therapeutics, had to say about our partnership:

"I would like to express my sincere recommendation about INITS as a professional consulting and supporting partner. INITS’ highly skilled team supported our vision, focusing on our requirements, and entirely completed each task in the expected timing. INITS team was contracted for supporting the CMC development of several programs. Our requests ranged from specific advice on the development of manufacturing process and analytical characterization and quality controls, to support writing documentation dedicated to regulatory scientific advice. Each time, the well-experimented INITS team brought its experience, the last trends, and regulatory bodies expectations. They provided appropriate recommendations to support the development of compliant product and consistent advice to address technical issues.

The added values of INITS are its rapid responsiveness, their precise and well-founded answers, the fairness and honesty of their answers, a very good listening and friendly exchanges. INITS also provided a very complete GMP compliance training to most of the Coave Therapeutics team. In addition to the highly professional content, the pleasant atmosphere of the training eased the team learning."

At INITS, our mission is to empower biotech innovators like Coave Therapeutics by providing tailored, high-quality support. Guided by our core values — Synergy, Audacity, and Integrity — we deliver strategic solutions to help our partners meet their regulatory, quality, and CMC goals. From early-stage development to regulatory submissions, we tackle each challenge with agility, precision, and a passion for excellence.

A big thank you to Coave Therapeutics for their trust and collaboration. We look forward to continuing this exciting journey together and advancing the future of gene therapy!

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