Your Trusted CDMO for Rapid Diagnostic Innovation
Delivering Rapid Testing Solutions Across Human, Animal, and Environmental Health
More Than a Development Partner
At Gila (pronounced HEE-luh) Bioscience, we’re more than a development partner—we are your dedicated Contract Development and Manufacturing Organization (CDMO), combining deep scientific knowledge with proven commercial experience to accelerate diagnostic innovation. Founded in 2024 and headquartered in Carlsbad, California, Gila was created to bridge the gap between concept and commercialization for point-of-care diagnostics.
With over 45 years of combined industry experience, our team brings extensive expertise across assay development, contract manufacturing, regulatory consulting, and custom reagent development. Whether you’re launching a human health test or scaling a veterinary or food safety assay, we act as a flexible, full-service CDMO to get you to market faster with confidence.
Our Mission
To transform diagnostic innovation into accessible, real-world solutions empowering our partners with rapid, high-performance testing that supports faster decisions and safer outcomes.
What We Do Best
Gila Bioscience serves as a full-spectrum CDMO, offering end-to-end support for companies developing point-of-care diagnostics. From early feasibility studies to scale-up, regulatory guidance, and GMP-compliant manufacturing, we customize every engagement to meet your needs.
End-to-End Capabilities
From prototype to submission, we handle all phases of assay development as your CDMO partner.
Deep Regulatory Expertise
Decades of experience navigating FDA, USDA, and IVDR requirements.
Custom Reagent Development
Proprietary conjugation chemistries and nanoparticle formulations tailored to your assay.
Transparency & Quality
ISO 13485–aligned practices with full documentation and client-owned design history files.
Application Diversity
Versatility across lateral flow, ELISA, flow-through, and emerging microfluidics platforms.
Industries We Serve
Human, Veterinary, Agriculture, Pharma, Environmental, Food Safety, and Biodefense.
Leadership
Joe Kaeller
Managing Partner
With over 25 years of experience in assay development, manufacturing, and regulatory consulting, Joe has led projects spanning lateral flow, molecular diagnostics, and biodefense. He has played pivotal roles in securing government contracts, developing FDA-cleared assays, and building ISO-compliant quality systems.
Bret Sheffield
Managing Partner
With over two decades in the IVD industry, Bret brings extensive experience in assay development, design transfer, regulatory documentation, and manufacturing across human, veterinary, and food safety markets. He has led cross-functional teams and successfully brought multiple assays to FDA and USDA markets.
Your Innovation Partner in Diagnostics
Whether you’re an early-stage biotech, an established diagnostics company, or a government program in need of a rapid assay, Gila Bioscience is the CDMO built to deliver. We offer flexible, collaborative partnerships backed by science, speed, and precision.
(833) 710-0912
info@gilabioscience.com