Services That Solve Problems
Pair Q-Biotech expertise with the Inceptum™ platform to bridge the gap between ideas, validated workflows, and compliant production.
We blend molecular biology, chromatography engineering, and regulatory insight so you can navigate complex purification, assay development, and scale-up challenges with confidence.
Custom Purification & Assay Development
- Tailored purification protocols optimized for client samples such as IgG, His-tagged proteins, diagnostic antigens and others.
- Development of custom cartridges and workflows for unique applications.
Contract R&D & Pilot Manufacturing
- End-to-end antibody and protein purification services from small-batch R&D to pilot-scale runs.
- Expertise in scaling processes under cGMP and ISO 13485 frameworks.
Regulatory-Compliant Validation
- Development and validation of purification methods suitable for diagnostics, vaccines, and therapeutic applications.
- Consulting support for FDA and international regulatory submissions.
Scientific & Strategic Advisory
- Direct access to leadership with 30+ years of product development, 70+ patents, and success in diagnostics and vaccines.
- Support for biotech and diagnostics startups needing scientific, business, and IP strategy.
Training
- Hands-on workshops for academic and corporate labs adopting the Inceptum platform.
- Virtual training and help with Inceptum™ use and operation
Custom Instrumentation & IVD Sensor Development
- Design and build of benchtop or compact instruments integrating mechanics, electronics, and control firmware.
- Development of IVD sensors and cartridges (e.g., electrochemical/affinity capture) from rapid prototype to pilot builds.
- Experience advancing IVD systems toward 510(k) submission within ISO 13485–aligned quality frameworks.
- IP-backed solutions grounded in extensive diagnostics product and patent experience.
How we engage
- Discovery session to frame goals, constraints, and success metrics.
- Co-authored plan for experiments, documentation, and deliverables.
- Iterative execution with transparent data and weekly checkpoints.
- Technology transfer, training, and follow-on support as you validate or scale.
Scope & transparency
Q-Biotech delivers process development and validation support. We follow ISO 13485 and cGMP practices in our documentation, but we are not a certified manufacturer and do not provide pilot-scale production. Engagements are tailored to your team, timeline, and regulatory pathway.
Ready to start a project?
Share your objectives and constraints and we'll assemble the right scientists and engineers to help you move forward.