Bring your assays to clinical use
Translate your Biomarker Research into a diagnostic product either as RUO (Research Use Only), IVD (In Vitro Diagnostics), or LDT (Laboratory Developed Test) assay
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How to translate your innovation to a product
Problem
Converting biotech innovation to a diagnostic product necessitates stringent design control measures, compliance with regulations, and make-or-break business decisions.
Solution
GMP production provides the design control and regulatory framework to bring an assay to clinical use. With over 150 biomarker projects we bridge the chasm that often exists between research and commercialization.
What is the GMP production service for IVD, RUO, or LDT?
GMP production service refers to the design, development, production, and commercialization of your novel biomarker findings in order to be used in clinical practice either as RUO (Research Use Only), IVD (In Vitro Diagnostics), or LDT (Laboratory Developed Test) assay.
It’s surprising for many to learn that even a set of biomarkers with exceptional clinical performance may face numerous hurdles before it can be successfully deployed in a clinical or pharmaceutical setting.
Several crucial elements must be meticulously addressed for a research project to realize its full commercial potential. Compliance with In Vitro Diagnostic Regulations (IVDR), ISO13485 standards and other local regulations are essential to ensure the quality, safety, and efficacy of the diagnostic product. Strict adherence to Good Manufacturing Practices (GMP) can further secure consistent delivery of high-quality products in the market.
By adopting a quality and regulatory centered approach for development and manufacturing you can significantly enhance the commercial viability of your discoveries and contribute to practical improvements in healthcare.
Why choose a GMP production service?
Biomarker Translation:
Follow an established development process to translate your discoveries into clinical use.
Serology Assay Production:
Harness our expert knowledge to produce high quality and reliable serological assays for use in vaccine batch release.
GMP-grade assays for Pharma:
Rely on GMP-grade assays for use in your QC processes or clinical validation before batch release.
Advanced Material Testing and Optimization:
Utilize cutting-edge techniques for material identification, sourcing, preparation, and testing and ensure optimal performance of your product.
Risk Mitigation:
Minimize and mitigate your risk during the feasibility and development stages, ensuring a smoother path to market.
Adherence to Regulatory Standards:
Comply with ISO:13485 and IVDR regulation, ensuring the highest quality and reliability of your developed assays.
Transfer to Manufacturing:
Transition efficiently from development to manufacturing, with comprehensive documentation and quality management system integration.
Commercialization:
Create an aesthetically beautiful product under regulatory-compliant labeling and packaging processes and bring it to clinical use.
What platforms are supported?
Our specialized GMP service provides comprehensive support for a range of diagnostic platforms depending on the specifications.
LuminexTM: For advanced multi-protein diagnostic products
ELISA: For reliable and precise immunoassays
Lateral Flow: For rapid and user-friendly diagnostic testing
How it works
- Feasibility study
The initial step is to evaluate whether the assay can be developed in the selected platform:
- Material identification, sourcing & preparation
- Material testing (antibody pairwise testing)
- Detection of analyte in sample of interest
- Development & Optimization
The assay is developed to meet design requirements and verified according to ISO13485 and IVDR:
- Design initiation plan
- Material preparation and optimization
- Analytical performance verification
- Clinical performance validation
- Design freeze
- Transfer to Manufacturing
The assay is transferred to manufacturing with the accompanying documentation and manufacturing lots prepared for regulatory purposes:
- Preparation of technical specification documents
- Integration into company’s QMS
- Three lots produced for customer’s verification & validation purposes (CE marking or FDA submission)
- Consultation & Support
Support and consulting at all stages from feasibility to commercialization:
- Platform selection
- IP search
- Market research
- KOL support
- Regulatory strategy
Why Protavio?
20+ years of multiplex proteomics experience
GMP, ISO:9001, ISO:13485 compliant processes
Advanced bioinformatic analysis for proteomics
Orthogonal biomarker validation with multiple platforms
The Team
Leonidas Alexopoulos
PhD, Acting CEO, Professor, National Technical University of Athens
Leonidas is one of the pioneers of multiplex assays & systems biology with more than 20 years of experience in the field of proteomics. He has studied at Duke, MIT and Harvard and is currently a professor at National Technical University of Athens. Leonidas co-founded Protavio in 2011 with the ultimate goal of improving people’s health through innovation in proteomics.
Sophia Stamatatou
Co-founder, COO & Quality Director, MSc, MBA
Sophia holds an MSc in Robotics & Automation and an MBA from National Technical University of Athens. Her passion for engineering and entrepreneurship led her to co-found Protavio in 2011. Since 2018, she has held the position of Chief Operating Officer and Quality Director. Her decade long experience of business development and administration make her a key decision maker in Protavio.
Nikos Tsolakos
Chief Scientific Officer, Phd
Nikos holds a PhD from Imperial College London and has over 15 years of work experience in academic and industrial research positions in the field of proteomics. Nikos joined Protavio in 2017 as a Quality Assurance & Project Manager. Since 2023, he holds the position of Chief Scientific Officer to advance Protavio’s proteomic solutions.
Christos Fotis
Chief Innovation Officer, Phd
Christos holds a PhD in AI & Bioinformatics from National Technical University of Athens and has extensive experience in creating and managing R&D projects and consortia. Christos joined Protavio in 2021 as a Research & Innovation manager. Since 2023, he holds the position of Chief Innovation Officer to drive new innovative projects using proteomics.