Sevilito CMC Biotech

Value Proposition

Biotech startups often lack in-house CMC expertise but must meet stringent regulatory demands to progress to first-in-human trials. Sevilito CMC Biotech bridges this gap by:

• Focusing on the unique needs of small biotech companies.
• Offering expertise in global CMC regulatory environments.
• Scientific and technical expertise in developing and implementing robust manufacturing processes for biologics, conjugates, and radiopharmaceuticals.
• Helping clients accelerate timelines, minimize risk, and maximize resource efficiency during the critical transition from preclinical to clinical phases.
• Independent consultancy with no ties to other companies or interest.

From Lab to Clinic – Navigating CMC with Precision

Recognizing that the journey from discovery to clinical testing is filled with challenges and uncertainties, the Sevilito CMC Biotech approach is grounded in:

• Speaking the language of scientists and understanding the realities of GMP manufacturing.
• Providing steady, experienced guidance as projects evolve - and when turbulence inevitably strikes.
• Knowing what to do when – and what not to do …. at least right now.
• Maintaining a high-level perspective while solving complex, multi-stakeholder problems – always having the end goal in mind.