As you manufacture monoclonal antibodies for both the clinical and commercial stages of development, BioReliance® End-to-End Solutions is the CDMO partner to guide you down your chosen path. Whatever the scale of your work, we'll build a flexible partnership based on scientific knowledge, operational excellence, quality, and regulatory compliance, and tech transfer.
Our three biodevelopment centers across the USA, France, and China, allow us to reserve slots to fit your timeline. Plus, our industry-leading single-use technology, give us the flexibility to reserve slots for small batches or increase capacity for large ones in alignment with your needs.
Our highly experienced experts will help you to optimize, scale, and validate your manufacturing process to get you to late clinical and commercial success. And if at any point you need to tech transfer, we can facilitate late-stage tech transfer with a direct, efficient, and robust process wherever you need to go.
We can also provide commercial drug substance supply via our GMP commercial facility in Martillac, France or support you in your own facility anywhere in the world, ensuring full regulatory compliance wherever you produce.
Our regulatory expertise can help you mitigate risk, providing data in line with a robust validation strategy and by regular upfront interaction with regulatory authorities. We support your CMC content writing for your clinical and commercial applications, as well as develop a full-proof regulatory strategy. With 25+ years of experience in GMP biopharma manufacturing and 85+ GMP Drug Substance batches released, our dedicated team will design and manage your process with openness and transparency at every stage.
— Client quote about our CDMO services
We are an established CDMO and our multi-disciplinary team has more than three decades of experience with hundreds of biologics – providing technology, equipment, and expert counsel you can trust. Since 2012, we have used single-use technology to produce:
Webinar: Tech transfer and Scale-up - Tips and tricks from a Biodevelopment Center
Case Study: Optimize the Formulation for a Monoclonal Antibody
Case Study: Reduce the Host Cell Protein from Bioreactor Harvest
Case Study: Scale Your Process Directly from 3 L to 2,000 L
eBook: Optimize Your Analytical Package for Greater Risk Reduction
Request information from our upstream and downstream process development experts: