Accurate, Innovative, High-Quality Diagnostics

InBios is a leading biotechnology company based in Seattle, Washington (USA). They specialize in the design, development, and manufacture of immunodiagnostic devices for infectious diseases. As such, they have specifically targeted those diseases that afflict tens of millions of people worldwide. They serve the global public marketplace by providing superior quality products that are accurate, easy to use and cost effective.

They have a competent and dedicated staff. Their team of scientists and engineers have over 30 years of expertise in developing and manufacturing in vitro diagnostic tests. InBios’ staff of scientists and engineers develop and manufacture high-quality, cost-effective, and accurate immunodiagnostic products. They have recruited a diverse, well-trained and highly educated group of dedicated professionals, which enables them to bring you reliable and practical solutions for challenging infectious disease diagnoses.

InBios has a long history of market leadership with a number of its products. They have a world-class technology development program. A number of their quality reagents have been licensed for research and emerging disease threat diagnostic applications. They have partnered with other private companies, federal laboratories and academia to bring their customers the best scientific solutions for their diagnostic needs.

They offer an impressive line of FDA cleared and USDA licensed products. All of their products are manufactured in the United States under rigorous quality control and performance validation procedures. Their facility is ISO 13485:2003 certified. All diagnostic products are manufactured under GMP, and most are CE Marked according to EC IVD Directive 98/79/EC.

InBios products are available in a variety of convenient formats. They continue to develop new products to complement their existing product range through Research and Development. They can assist you by providing an Analyte Specific Reagent or a custom-built assay through their Contract Manufacturing business unit. They also have the capability to rapidly scale-up production in response to public health emergencies.

InBios Contract Manufacturing Services

Custom-made, High-quality Reagents and Assays

They know that their success depends on your success. They work efficiently to meet the needs of their customers while abiding by their commitment to quality. Here are five important reasons why you would want them to develop your reagent or build your assay:

• -InBios is a full service medical device diagnostic product cGMP manufacturer with ISO 13485 certification and FDA registration.
• -InBios employees are skilled in the development, validation, and packaging of diagnostic products. They have served a wide array of customers in many settings and applications.
• -InBios excels at providing personalized technical and customer service. Their broad array of process capabilities, foremost attention to quality, total responsiveness, and efficient operation offer excellent value.
• -InBios products are based upon solid scientific discovery, validation and quality assurance. A large portion of their staff have advanced degrees, extensive training and work in R&D and assay optimization.
• -InBios products are cost-effective and competitively priced, which will allow you to utilize them to meet your diagnostic or research needs.

Custom Assay Development Services

Assay development solutions tailored to your needs

When commercial off-the-shelf (COTS) products are not enough, trust InBios to develop a solution that will provide the quality results you require. InBios offers a range of custom development services including bioassays for agent identification, process development and basic research. Their team of molecular biologists and assay developers will work with you to deliver an immunodiagnostic solution that provides the quality results you expect.

Available Services:

• -Feasibility studies
•  -Production of conjugates, including various size gold particles
•  -Prototype & beta test development
•  -Full FDA compliance – design plan & design history files prepared
•  -Laboratory studies – accelerated stability, cross-reactivity, interference, precision
•  -Analytical sensitivity & specificity studies
•  -Clinical trial management
•  -FDA product submissions [510(k) & PMA]
•  -Full turnkey option available: feasibility study to FDA submission
•  -Expert regulatory guidance on all design & manufacturing issues
•  -Small & large scale manufacturing of rapid & ELISA based immunoassays