Biologic Manufacturing
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.
Clinical and commercial manufacturing success
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.
“We screened eight CDMOs before selecting Merck as a partner. Our choice came down to many factors including expertise, capabilities, timing, team chemistry, and efficient communication. It is also well-known that the company develops the equipment for manufacturing biologics – the insight from this aspect of their business is invaluable.”
— Client quote about our CDMO services
25+ years of experience in GMP manufacturing
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:
- mAbs: More than 60 GMP batches manufactured in scales from 200 L to 2,000 L
- Recombinant proteins: More than 15 GMP batches manufactured in scales from 200 L to 1,000 L
- Fab: More than 3 GMP batches manufactured in 200 L scale
- Fc-fusion: 1 GMP batch manufactured in 200 L scale
Our Track Record |
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Related Product Resources
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
Best Practices: Tech Transfer Key Considerations
Webinar: Tech transfer and Scale-up - Tips and tricks from a Biodevelopment Center
Webinar: A Scale up to 2000L, Blindfolded
CDMO Case Study: Be Ready for Commercial-Scale Single-Use Manufacturing
Whitepaper: Trends in Outsourcing the Development and Manufacturing of Biologics
Request information from our upstream and downstream process development experts:
Burlington, Massachusetts
- Fully single-use manufacturing capabilities
- Pilot production up to 200 L
- Non-GMP clinical production
- 100% success rate in client audits
- Footprint 1,500m²
Martillac, France
- Fully single-use manufacturing capabilities
- Pilot production up to 200 L
- GMP clinical production up to 4,000 L
- GMP commercial production in 2022
- 8 single-use bioreactors
- 3 manufacturing suites
- Footprint 4,100m²
- Quality Control lab 1,500m²
- Analytical methods development lab 400m²
- GMP-certified since 1995
- Audited and approved by the French Health Authority ANSM
- Audited by the U.S. FDA, Japanese, and Australian authorities as well as many biotech clients
Shanghai, China
- Fully single-use manufacturing capabilities
- Pilot production up to 200 L
- GMP clinical production up to 2,000 L
- Footprint 5,150m²
- Compliant to NMPA, U.S. FDA, and EMEA