Avance Biosciences delivers robust and reliable immunoassay services to support the biologics development and approval process, from pre-clinical testing through manufacturing. The FDA, EMA, and other regulatory agencies require rigorous protein analysis, using validated assays, to ensure drug efficacy and safety. Our CGMP and GLP-compliant protein analysis services are built on sound science and regulatory expertise, so we can develop and validate the best immunoassays for your program, perform accurate sample testing, and go above and beyond the needs of regulatory bodies.
Preclinical / Clinical
Our GLP-compliant lab provides accurate and reproducible off-the-shelf or custom immunoassays to accommodate your pre-clinical or clinical sample testing, even at large scales.
Biologics Manufacturing QC
Residual Host Cell Protein (HCP) Analysis
We precisely quantify residual HCPs for your manufacturing QC and lot release testing under GMP compliance, mitigating safety risks and ensuring your regulatory needs are met.
For decades, we’ve developed and validated GLP- and GMP-quality qPCR and sequencing assays for biodistribution studies and manufactured product release. Our protein analysis services are a natural addition to these core competencies, enabling you to access more complete and thorough HCP analysis and biodistribution services, with the same collaborative, experienced, and dedicated team.
We excel at finding creative, timely solutions to meet your needs. Whether you need an off-the-shelf or a custom assay, developed and validated from scratch, you can expect a thoughtful approach, catered to your timeline. Our liquid handling and automated Western blot instruments facilitate scalable sample testing so you can generate high-quality data and hit your milestones on time.
We value open and collaborative communication with our partners across the globe. Before we take on a project, we ensure that we have a solid understanding of your project. And if we can’t meet your expectation or run into problems along the way, we talk about it. We are dedicated to providing you with timely, high-quality service from the start of your project to the finish.
We are continuously expanding our portfolio of protein analysis services. If you’re interested in biomarker analysis, stability studies, immunogenicity assays, or other assays, reach out to us below.
Our Customers Say…
From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor…
Project Manager, Belgium
Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.
Program Manager, California
It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences’ services to colleagues and friends.
Senior Scientist, Singapore
When you partner with Avance Biosciences, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!
Dedication to Quality
The Avance Biosciences team is committed to strict adherence to GLP and CGMP regulations enacted by the US, European, Japanese, and other international regulatory agencies.
Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.
Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.
Cutting Edge Science
Avance Biosciences’ GLP/GMP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, digital PCR, Sanger sequencing, next generation sequencing, and more.