Chromatography Development Services
Put Decades of Downstream Process Development Expertise to Work
Sartorius experts represent extensive experience in chromatography and purification of biomolecules as well as analytical methods development. Whether you need technical guidance to leverage all the benefits of monolithic chromatography or support in development to maximize productivity and efficiency while ensuring quality, Sartorius is committed to serve you with a wide range of custom solutions.
Monoliths Service Offering
Sartorius‘ facilities are fully equipped to handle process and analytical method development for biomolecules up to biosafety level 2. Our technical experts will prepare a work plan to meet your specific needs, while project managers ensure you stay connected throughout development.
Downstream Process Development
Downstream process development, starting from lysis or capture to final polishing and formulation of your biomolecule (viruses, pDNA, bacteriophages, extracellular vesicles, proteins, PEGylated proteins, etc.). Sartorius will create:
Processes suited to any stage – clinical phases to market supply – developed exclusively on monolithic columns.
A customized multistep process that can include development of lysis method, chromatographic media selection and optimization, virus inactivation, filtration, and tangential flow filtration.
Recommendations of appropriate analytical methods.
Tech transfer of standard operating procedures (SOP) to your facility or CMO.
Developing the Right HPLC Analysis
Impurity detection and removal is a crucial part of biomolecule downstream processing. HPLC is sensitive and has a broad dynamic range, providing a superior indication of purity. But designing the right application for specific products can be challenging. Sartorius‘ experts can develop the right on-line HPLC methods to get you to product release faster and with confidence.
HPLC Analytical Development
Development of HPLC analytical methods:
Methods for in-process control (PAT). Developed to increase control, improve efficiency and prevent rejection of batches of your upstream and downstream.
Methods for final control, that enable real-time release of products.
All methods can be validated. Sartorius‘ HPLC methods use CIMac™ Analytical Monoliths and are developed on PATfix® along with reference methods for characterization.
Analytical development Services also include method development of various analytical methods, validation and verification, transfer, and routine testing of pharmaceutical samples and biomolecules.
Affinity Columns, Designed for Purpose
Immobilization conditions suited to one particle might not be optimal for another despite apparent similarities. In affinity interactions, small changes in the conformation of the immobilized particle, as well as their environment, can affect their physio-chemical characteristics and affinity. Sartorius can create affinity columns tailored for your situation.
A range of activated monoliths provide the basis for immobilization of antibodies, proteins, peptides, enzymes, nucleic acids and small organic molecules. The ligand forms a stable covalent linkage with the monolith matrix and prevents leaching.
Our immobilization optimization service considers different activated monoliths, buffering systems, deactivation conditions and ligand densities and provides the right tools for the right applications.