Process Development Services
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.