Assay development and manufacturing services with a focus on creating tailored solutions to meet your specific research or diagnostic needs. We know each assay is different and our team leverages its decades of experience, across multiple platforms, and with varying design inputs, to bring you customized solutions for your project.  Whether it be visual or fluorescence, qualitative or quantitative, singleplexed or multiplexed, direct detection or competitive assays, the team at Gila Bioscience has experience with all in the platforms below:

• Lateral flow
• Flow Through
• ELISA
• Microfluidics

Contact us to discuss your next assay.

Scale up and tech transfer are requirements that are often overlooked when starting a project, but are crucial for bringing your development projects to market efficiently while maintaining acceptable standards of quality and performance.  The team at Gila have brought assays from protype to final product in the FDA and USDA markets, following all regulatory guidelines, and can help with many areas such as:

• Process Optimizations
• Scale-Up Planning and Protocols
• Quality Control and Risk Analysis
• Pilot Production Runs and Gap Manufacturing
• Post Transfer Monitoring
• Provide Technical Service
• Storage of Samples

Contact us to see how we can help you take your test from a prototype to a product.

Verification and validation work is critical in the development and transfer of diagnostics assays, ensuring that products meet specified requirements and are reliable for their intended use.  This is essential for ensuring that diagnostic assays are safe and effective, as well as meet performance and regulatory standards set by agencies like the FDA (Food and Drug Administration) and the USDA(Unites States Department of Agriculture).  With decades of experience working in both FDA and USDA licensed facilities, and bringing products to market in both, let us help you navigate the waters of analytical verification/validation and process validation by:

• Drafting Analytical Verification/Validation Plans and Protocols
• Execution of Analytical and Robustness Studies
• Sourcing Specific Samples
• Process Validations
• Master Validation Plan
• Consulting
• Testing Site
• On-going Stability and Environmental Studies

Contact the Gila team so we can put our years of experience to work for your product.

Each assay is different, and each requires a specific set of custom reagents, materials and chemistries to achieve the desired performance.  These custom reagents are essential for the development of an effective and reliable diagnostic assay.   Throughout our four decades of assay development experience, the team at Gila has developed many custom reagents across different platforms using various detector particles, enzymes and conjugation chemistries such as:

• Colloidal gold particles  – Contact us for pricing
• Custom passive and covalent conjugation to nanoparticles such as: colloidal gold, polystyrene latex, paramagnetic, cellulose nanobead and fluorophores
• Custom HRP (horseradish peroxidase) conjugates
• Small molecule and protein to protein conjugations

Contact us to see how we can help customize your assay to ensure the highest quality and best performance.

Our expert consulting services are dedicated to advancing your assay, offering comprehensive guidance across all stages of development, from early design to commercialization. With deep expertise in assay development, regulatory compliance, risk analysis, process optimization and manufacturing, let us help you to  meet the unique challenges of your project to deliver a high-quality, and robust product.

Contact the team at Gila Bioscience to see how we can help bring your idea to market.