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.
Request information from our upstream and downstream process development experts:
Leveraging our in-house expertise, we offer a complete range of process development (PD) services to improve yield and quality of your biologics.
As you move from cell line to upstream and downstream process development, we can help you build a robust, scalable process that brings you success now and into the future.
Our full cell line development capabilities and expertise span from DNA and vector constructs to top clonal selection, research and master cell banks, and stability studies.
We provide clinical and commercial drug substance supply globally based on harmonized templates and single-use equipment across drug development clinical and commercial manufacturing.
Our Fast-Track development service accelerates progress toward clinical and commercial milestones. We combine best-in-class templates, a multi-disciplinary team informed by three decades of technical experience, a full understanding of evolving regulatory requirements, and project managers fully vested in your success. Our single-use technologies offer unmatched flexibility for both clinical and commercial scale production, and for those times when demand changes unexpectedly. We are nimble, agile, and will advance your project quickly while mitigating risk – and that adds up to greater confidence for you.
Our Fast-Track capabilities span every step from DNA to commercial production.
Learn more about our Biologics fast track
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.
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:
Our Track Record
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 fool-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.
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
CDMO Case Study: Be Ready for Commercial-Scale Single-Use Manufacturing
Whitepaper: Trends in Outsourcing the Development and Manufacturing of Biologics
To continue reading please sign in or create an account.Don't Have An Account?