As contract research organization, Sartorius BIA Separations’ facilities are fully equipped to handle process development for particles up to biosafety level 2. Our sales and technical support team will prepare a work plan per your requirements. You may choose to be involved throughout the development via regular contact with the project manager.
Downstream Process Development:
- Processes suited to different clinical phases up to market supply – developed exclusively on monolithic columns.
- Starting from lysis or capture, to final polishing and formulation of your biomolecule (viruses, pDNA, bacteriophages, extracellular vesicles, proteins, PEGylated proteins, etc.).
- Depending on your product and requirements the multistep process includes development of lysis method, chromatographic media selection and optimization, virus inactivation, filtration, tangential flow filtration.
- Recommendation of suitable analytical methods.
- Tech transfer of standard operating procedures (SOP) to your facility or CMO.
Contact Us
Fill out the form below or write to: cornerstone@biaseparations.com